Reported trial results for Multiple Sclerosis
Every Multiple Sclerosis trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.
182 trials have reported results.
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
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NCT05123703 · results posted 15 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05123703) enrolled 93 people in the ocrelizumab group and 94 people in the fingolimod group — 187 participants in total — all of whom had multiple sclerosis (MS). The trial compared these two medicines and measured things like how often participants experienced MS relapses (periods when symptoms flare up or get worse), changes seen on brain scans, and how ocrelizumab moved through the body. Notably, the data shows that zero participants in either group were recorded as having "completed" the study, with all participants listed under "not completed"; no explanation for this was provided in the reported data. The reported data shows that, on average, participants in the ocrelizumab group had a relapse rate of 0.070 relapses per year, compared with 0.135 relapses per year in the fingolimod group. For brain scan findings, the total number of new or enlarging lesions (areas of change visible on a type of brain scan called an MRI) was 495 in the ocrelizumab group and 908 in the fingolimod group. At the 12-week mark, a different type of brain scan lesion — called a T1 Gd lesion (spots that light up when a special dye is used during the scan) — showed 5 in the ocrelizumab group and 33 in the fingolimod group. The trial also measured how ocrelizumab was absorbed and moved through the body, reporting a peak blood level of 142 micrograms per millilitre and a related exposure measure of 3,020 µg/mL·day; these figures were only measured for the ocrelizumab group. Data on adverse events (unwanted medical occurrences during the trial) was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04815967 · results posted 27 May 2026
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called MYOBLOC (a type of botulinum toxin) in people with muscle stiffness (a condition called spasticity). The trial had two phases: a blinded phase where 32 people were randomly assigned to receive either a high dose of MYOBLOC (10 people), a low dose of MYOBLOC (11 people), or a dummy treatment called a placebo (11 people), without knowing which they received. A further 24 people then entered an open-label extension phase, where everyone received MYOBLOC and knew they were doing so. The trial measured two main things four weeks after the injection: changes in muscle stiffness using a rating scale called the Modified Ashworth Scale (MAS), and a clinician's overall impression of how a person's ability to function had changed, using a scale called the Clinical Global Impression of Change (CGI-C). The reported data shows the following for muscle stiffness (MAS scores, where a more negative change from the starting score indicates less stiffness): the high-dose MYOBLOC group had an average starting score of 2.90 and a score of 2.05 at week four, giving a change of −0.85; the low-dose group went from 2.82 to 1.82, a change of −1.00; and the placebo group went from 2.73 to 2.65, a change of −0.05. For the clinician's impression of functional change (CGI-C, where lower numbers, below 4, suggest improvement), the reported data shows an average score of 2.4 for the high-dose group, 2.6 for the low-dose group, and 3.3 for the placebo group at week four. No outcome data was reported for the open-label extension phase. It is worth noting that all three groups in the blinded phase started with very similar average stiffness scores, and the numbers reported here are group averages — individual results within each group would have varied. No data was reported for the open-label extension phase completion, as all 24 participants who started that phase were listed as not having completed it, but no further explanation was provided in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04035005 · results posted 23 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04035005) enrolled around 505–508 people in the ocrelizumab group and 508 in the placebo group during the main double-blind phase. The trial was looking at a condition involving progressive disability — most likely primary progressive multiple sclerosis — and was primarily measuring how long it took before participants showed a meaningful, confirmed worsening in their disability. This worsening was tracked using two tools: a standard neurological scoring scale (where higher scores mean more disability) and a timed hand-and-arm test (where taking longer to complete it signals a decline). The trial also followed some participants through later open-label and follow-up phases. The reported data shows that, for the main (primary) outcome — time until a confirmed disability worsening sustained over at least 12 weeks — the ocrelizumab group reached that milestone at a reported median of approximately 204.9 weeks, while the placebo group reached it at approximately 133.6 weeks. For a separate subgroup analysis based on MRI activity, the data was not reported for the ocrelizumab group, while the placebo subgroup recorded 124.9 weeks. For the secondary outcomes, the reported data shows that time to a confirmed worsening on the hand-and-arm test alone (held for 12 weeks) was around 204.9 weeks for ocrelizumab and 203.3 weeks for placebo; for the neurological disability score alone (12 weeks), no value was reported for the ocrelizumab group, while placebo was 155.7 weeks. Similar patterns were reported for the 24-week versions of these measures, with some figures again not reported for the ocrelizumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04544436 · results posted 17 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04544436) enrolled 860 people with multiple sclerosis across two groups: 283 people received ocrelizumab at a dose of 600 mg, and 577 people received ocrelizumab at a higher dose of either 1,200 mg or 1,800 mg. The trial was designed to measure changes in disability over time, using three different tests — a standard neurological disability rating scale (called the EDSS), a timed 25-foot walking test, and a timed peg-placement hand test. The main question the trial was asking was how long it took before participants showed a confirmed worsening in any of these measures. The reported data shows that numerical results were not provided for any of the outcome measures — neither the primary measure (time to first confirmed disability worsening confirmed over 12 weeks) nor any of the secondary measures, which looked at worsening confirmed over 24 weeks and 48 weeks, worsening unrelated to relapses, and worsening on the individual walking and hand tests. All values are recorded as "NA" (not available) in the data submitted to ClinicalTrials.gov. The reported data also shows that zero participants in either group are recorded as having completed the study, with all 860 participants listed under "not completed," though no further explanation for this is provided in the submitted data. Because no numerical results were submitted for any of the outcome measures, it is not possible to describe what the trial found about the differences between the two dosing groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03594487 · results posted 3 February 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT03594487) enrolled a total of five participants — four in the group who received a faecal microbiota transplant (FMT, a procedure where gut bacteria from a donor are transferred to a recipient) and one in an observational comparison group who did not receive the treatment. All five participants completed the study. The trial was primarily measuring whether participants could complete the full schedule of study visits (at the start, then at 2, 4, 8, and 12 weeks, plus a longer-term safety check-in up to week 48), how the variety of bacteria in participants' guts changed over time, and whether any unwanted health events occurred. It also tracked levels of a particular type of immune cell in the blood (CD19+ B cells) as a secondary measure. The reported data shows that all four participants in the FMT group and the one participant in the observational group completed every study visit. To measure gut bacteria variety, researchers used something called the Shannon Index — a score where a higher number means a greater variety of bacteria present. In the FMT group, the reported Shannon Index score started at 0.87 at the beginning of the study and was recorded at 4.60 at week 2, 4.10 at week 4, 4.50 at week 8, and 4.10 at week 12. The reported data shows no serious unwanted health events (defined as moderate or worse in severity) were recorded at any time point in either group. One non-serious unwanted event was recorded at the start of the study in the FMT group, and none were recorded at any later time point or in the observational group. For the blood immune cell counts, the reported figures varied across time points; for example, in the FMT group the count was reported as 210 cells per microlitre at the start and 276 cells per microlitre at week 2, with subsequent time point data partially reported. Some data points across the secondary outcomes were not reported in the submitted results. It is worth noting that with only five participants in total, this was a very small study, and the data as submitted reflects that limited scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05888727 · results posted 30 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05888727) enrolled 23 people across two groups — 12 in an exercise training group and 11 in a wellness control group — though the recruitment goal recorded was 24 eligible participants overall. The study ran for 16 weeks and was primarily designed to test whether the trial itself was practical to run — in other words, could researchers recruit enough people, keep them involved throughout, and track any study-related unwanted events? These are known as "feasibility" measures, meaning the trial was checking whether a larger study could realistically be done in the future. The reported data shows that all 24 recruitment spots were filled within the target timeframe. Of the people who started, 10 out of 12 in the exercise group and 10 out of 11 in the wellness group completed the full 16 weeks, which the trial had set as an 80% or better retention goal. Regarding study-related adverse events (unexpected or unwanted experiences linked to the study), one participant in the exercise group had such an event reported, while none were reported in the wellness control group. The reported data also includes acceptability results — meaning how participants felt about the study. In interviews, 9 out of 10 exercise group completers and 8 out of 10 wellness group completers expressed positive views about their experience. On a post-study survey scored from 1 to 5 (where 5 means most acceptable), the exercise group scored an average of 4.5 and the wellness group scored 4.56. One secondary measure — changes in physical activity levels over the 16 weeks — was listed in the trial but no results data was reported for it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04230174 · results posted 30 December 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 20 people with multiple sclerosis, of whom 15 completed the study and 5 did not finish. The trial was measuring changes in brain scans over one year in people receiving a medicine called ocrelizumab. Researchers used specialised imaging to look at brain inflammation (using a type of scan called 11C-PBR28), the health of brain tissue (using a measure called magnetisation transfer ratio, or MTR — essentially a way of measuring how well the brain's structural proteins are holding together), the thickness of the brain's outer layer (cortical thickness), and the size of lesions (damaged areas) in the brain's white matter. The reported data shows the following numbers before and after one year of treatment. For the brain inflammation scan (SUVR — a standardised way of measuring how much of the imaging agent was taken up in different brain regions), values across various brain regions were reported as 0.9, 0.9, 1.31, 0.84, 0.83, and 1.23. For the brain tissue health measure (MTR), readings in two brain regions were reported as 27.9% and 17.3% at one time point, and 27.0% and 16.8% at another. For the brain's outer layer thickness, the reported measurements were 2.35 mm² at both time points. For white matter lesion size, the reported volumes were 6,248 cubic mm and 6,021 cubic mm at the two time points. It is worth noting that the data as submitted does not clearly label which measurements are "before" and which are "after" treatment, so the direction or size of any changes cannot be determined from the figures provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04353492 · results posted 12 November 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 562 people, all of whom received a treatment called ofatumumab. The trial was set up to measure how often participants experienced relapses (periods when multiple sclerosis symptoms flare up or worsen) over the course of the study. Specifically, it tracked the annualised relapse rate — that is, the average number of confirmed relapses per person per year. A total of 523 people completed the study, while 39 did not finish. The reported data shows that the average number of confirmed relapses per person per year was 0.06. To put that in plain terms, on average participants experienced fewer than one tenth of a relapse per year across the study period. The trial had set out to test whether this rate would come in below 0.18 relapses per person per year, and the reported figure of 0.06 sits below that threshold. The reported data also shows that, out of 562 participants, 509 experienced at least one adverse event (an unwanted or unexpected health occurrence during the study), and 33 experienced a serious adverse event (a more significant health occurrence). More specifically, 374 participants had injection-related reactions reported, 5 had abnormal laboratory results or vital signs that qualified as adverse events, and 33 had other adverse events recorded. It is worth noting that recording these events is a standard part of any clinical trial and does not on its own indicate anything about whether a treatment is safe or unsafe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05604170 · results posted 1 October 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05604170) enrolled 117 participants who were given ganaxolone oral suspension, taken three times a day. The trial was measuring a range of safety-related observations, including unwanted medical events (called adverse events), changes in vital signs such as heart rate and blood pressure, physical and neurological check-ups, developmental assessments in children, and heart rhythm readings (ECGs). The reported data shows that, when it came to unwanted medical events, 79 out of 117 participants experienced at least one treatment-emergent adverse event (meaning a medical occurrence that happened after starting the study drug). Of those, 21 participants experienced a serious adverse event — defined as one involving hospitalisation, a life-threatening situation, lasting disability, or death. The data also shows that 16 participants had their dose reduced due to an adverse event, and 6 participants withdrew from the study because of an adverse event. It is worth noting that the results data records zero participants as having "completed" the study, which may reflect how the trial's completion was defined rather than meaning all participants stopped early — however, no further explanation for this was provided in the reported data. For the remaining primary measures — clinically significant changes in vital signs, physical examinations, neurological examinations, developmental examinations (for participants aged 1–17), and ECG readings — the reported data shows zero participants had findings considered clinically significant in any of these areas. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04667949 · results posted 29 August 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04667949) looked at fingolimod, a tablet used for multiple sclerosis (MS), in two groups of people in Australia: 11 participants who were under 18 years old, and 87 who were 18 or older. The main thing being measured was how often participants had MS relapses — that is, episodes where MS symptoms appeared or got noticeably worse. The trial also looked at changes seen on MRI brain scans and recorded any unwanted medical events (called adverse events) that occurred while people were taking the medication. The reported data shows that, for the adult group (18 and over), the primary measure — an adjusted relapse rate calculated using a statistical model — came out at approximately 0.018 relapses per person per year. To put that in plain terms, the model estimated that, on average across the group, there was less than one relapse every 50 years per person, though this is a group average and not a prediction for any individual. A separate, simpler calculation of relapse rates was also reported: for the under-18 group this was around 0.20 relapses per person per year before adjusting, and 0.10 for the adult group. For MRI scans, the annualised rate of new or growing lesions (areas of MS activity visible on the scan) in the adult group was reported as approximately 1.3 per person per year. The average change in the number of new or enlarged lesions from the start of the study was reported as 1.8 for the under-18 group and 1.8 for the adult group at one time point, rising slightly at a later point. Regarding unwanted medical events, the reported data shows that all 11 younger participants and 86 of the 87 adult participants experienced at least one adverse event during the study. Serious adverse events were recorded for 3 participants in the under-18 group and 12 in the adult group. No deaths were reported in either group. These numbers describe what was observed and recorded during the trial; they do not on their own tell us whether events were caused by the medication. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05323734 · results posted 11 July 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called ganaxolone in people with a rare genetic epilepsy condition called CDKL5 deficiency disorder (CDD), which causes frequent and difficult-to-control seizures. A total of 129 participants took part — 64 received ganaxolone and 65 received a placebo (a dummy treatment with no active ingredient). The main thing the trial was measuring was whether ganaxolone changed how often certain types of seizures occurred over a 28-day period compared to the start of the trial. The reported data shows that, on average, participants in the ganaxolone group had a 7.5% reduction in their seizure frequency from their starting point, while participants in the placebo group actually had a 13.57% increase in seizure frequency over the same period. For a secondary measure — looking at how many participants had at least half as many seizures as they started with — the reported data shows 12 out of 64 participants in the ganaxolone group reached that level, compared to 8 out of 65 in the placebo group. The trial also asked parents or caregivers and clinicians to rate overall change on a 7-point scale (where 1 means "very much improved" and 7 means "very much worse"). The reported data shows that among parent/caregiver ratings, 5 ganaxolone participants were rated "very much improved" versus 8 in the placebo group, and 16 ganaxolone participants were rated "much improved" versus 15 in the placebo group. Clinician ratings showed a broadly similar spread across the two groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04934800 · results posted 24 June 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 256 people with multiple sclerosis (MS) who were treated with a medicine called cladribine. A total of 234 people completed the study, while 22 did not finish. The trial was measuring changes in how often participants experienced MS relapses (episodes where symptoms appear or worsen) over two years, as well as any changes in their level of disability. The reported data shows that the main thing being measured — the average number of relapses per year — went down by 1.12 relapses per year when comparing the 12 months before treatment to the 12 months leading up to the end of the two-year study. A similar secondary measurement looked at the first 12 months after starting treatment, and that showed a reported reduction of 1.01 relapses per year compared to before treatment. For disability, which was measured using a standard scale (scores ranging from 0, meaning no disability, to 10), the reported data shows that 1.6% of participants showed worsening of disability over six months when measured by that scale alone, and 4.7% showed worsening when three different disability tests were combined. On the other side, 1.6% of participants showed an improvement in disability on the main scale, and 4.7% showed improvement when all three tests were combined. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01450072 · results posted 18 June 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT01450072) involved 20 people with multiple sclerosis (MS) who had also been diagnosed with a condition called CCSVI — a proposed narrowing of veins that drain blood from the brain. Participants were split into two groups of 10: one group received a real balloon angioplasty procedure (a technique used to widen narrowed veins), while the other group received a sham (pretend) procedure involving only an imaging scan of the veins, with no actual treatment. The trial was measuring, firstly, how many people experienced serious unwanted medical events shortly after the procedure, and secondly, how many people showed improved blood flow through those veins one year later. The reported data shows that for the primary outcome — serious adverse events recorded shortly after the procedure and at one month — zero participants in either group were reported to have experienced such an event. For the secondary outcome — the number of participants showing more than 75% of normal blood flow at one year after the procedure — the reported figure was also zero in both groups. It is worth noting that one participant in the active treatment group did not complete the study, though the reason was not detailed in the submitted data. These results as described reflect only the numbers submitted to the registry; the reported data shows what was measured and counted, but does not on its own explain the broader meaning or context of those figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04411641 · results posted 18 June 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04411641) looked at a medicine called tolebrutinib (60 mg) compared to a placebo (an inactive dummy treatment) in people with multiple sclerosis (MS). In the main, double-blind phase of the trial — where neither participants nor their doctors knew who was getting which treatment — 377 people received the placebo and 754 received tolebrutinib. A smaller, open-label follow-on phase (where everyone knew they were receiving tolebrutinib) involved a further 196 participants. The trial's main focus was on measuring how long it took before a participant's disability, as measured by a standard MS disability scale called the EDSS (which runs from 0, meaning no disability, to 10), worsened in a meaningful and lasting way over at least six months. The reported data shows that, for the main outcome — time until a confirmed, lasting worsening of disability over six months — the placebo group reached that point at a median (middle value across the group) of approximately 11.97 months, while the tolebrutinib group reached it at approximately 12.04 months. For a similar measure tracked over three months instead of six, the figures were approximately 11.96 months (placebo) and 12.04 months (tolebrutinib). The reported data also shows that, on average, participants taking tolebrutinib had approximately 1.84 new or enlarging brain lesions per year on MRI scans, compared with approximately 2.95 in the placebo group. For the walking test and hand-dexterity test outcomes, as well as for the measure of disability improvement, the reported numbers between the two groups were broadly similar and close together. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04338022 · results posted 12 June 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04338022) compared two treatments for multiple sclerosis (MS) — teriflunomide and evobrutinib — over a main treatment period of 156 weeks (about three years), followed by an extension period of a further 96 weeks (roughly two more years). A total of 564 people were assigned to the teriflunomide group and 560 to the evobrutinib group at the start of the main period. The trial's main focus was on measuring how often participants experienced MS relapses (episodes of new or worsening symptoms lasting more than 24 hours), and it also tracked things like changes in disability levels and how participants felt about their own physical functioning. The reported data shows that, when looking at relapses per year, the teriflunomide group averaged 0.13 relapses per year and the evobrutinib group averaged 0.14 relapses per year across the combined treatment periods. For disability progression — meaning a measurable worsening of a participant's condition confirmed over either 12 or 24 weeks — the reported data shows that around 91% of participants in both groups had not experienced confirmed worsening at the 12-week mark, and around 92–94% had not at the 24-week mark. A small proportion of participants in both groups showed confirmed disability improvement: around 7.9–8.8% in the teriflunomide group and 9.4–10.1% in the evobrutinib group, depending on the time point. Changes in self-reported physical function scores were small in both groups across all time points measured. For the much smaller open-label extension phase (only 3 participants, all from the evobrutinib group), the reported data shows that 1 participant experienced an adverse event (an unwanted medical occurrence during the study period) and 0 participants experienced a serious adverse event. No adverse event data from the main 156-week or extension periods was reported under the primary outcome measures in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05116540 · results posted 7 May 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05116540) looked at quality of life in people with multiple sclerosis (MS). A total of 24 people took part — 12 in the treatment group and 12 in the placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). Of those, 11 people in the treatment group and 10 in the placebo group completed the study. The trial measured quality of life using a 54-question MS-specific survey called the MSQOL-54, which covers areas like physical health, mental health, emotional wellbeing, cognitive function (thinking and memory), health-related distress, and role limitations due to emotional problems. Each area is scored from 0 to 100, where a higher score means better quality of life. The reported data shows the scores at the start of the study and how much they changed by the end. For overall physical health quality of life, the treatment group started at around 53.9 out of 100 and showed a change of approximately +16 points, while the placebo group started at around 44.1 and showed a change of approximately +2 points. For overall mental health quality of life, the treatment group started at around 65.4 and changed by approximately +13.5 points, while the placebo group started at around 60.9 and showed a change of approximately −2.6 points. For individual sub-scores: cognitive function changed by about +9.6 points (treatment) versus −2.5 points (placebo); emotional wellbeing changed by about +12.4 points (treatment) versus −1.2 points (placebo); health distress changed by about +25 points (treatment) versus −2 points (placebo); and role limitations due to emotional problems changed by about +18.2 points (treatment) versus −10 points (placebo). The reported data does not include information about whether these differences were statistically meaningful (that is, whether they were large enough to be unlikely due to chance), so those figures were not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT06019611 · results posted 27 April 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT06019611) involved just 2 participants, both of whom completed the study. The trial was testing a technique called percutaneous epidural stimulation — where electrical signals are delivered to the spinal cord through the skin — in people with movement difficulties. The study measured a range of things including knee movement during walking, balance, muscle activity, muscle stiffness (called spasticity), and walking speed. Measurements were taken at the start of the study, at the end of the study with the stimulation turned off, and at the end of the study with the stimulation turned on, to allow comparisons. The reported data shows the following numbers across the outcome measures. For knee bending during walking, the reported changes were 15.5 degrees and 10 degrees across the two comparisons measured. For balance (with eyes open and eyes closed), the reported figures showed changes in the area of body sway ranging from −29% to −90%, where a negative number means the sway area got smaller. For muscle activity in the thigh muscles during walking, the reported changes were −7% and +20%. For muscle stiffness around the knee, one test (called the pendulum test) showed a change of 6.5 degrees; another standard clinical rating scale for stiffness (scored 0 to 4, where lower means less stiffness) showed scores ranging from 0 to 2 across different conditions and sides of the body. For walking speed, the reported changes were −25% (comparing start to end of study with stimulation off) and +15% (comparing stimulation off to stimulation on at the end of the study). It is worth noting that with only 2 participants, this was a very small study, and the results reflect the experience of just those two individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04942938 · results posted 18 April 2025
According to the results reported on ClinicalTrials.gov, this trial involved 7 people with multiple sclerosis (MS), and all 7 completed the study — none dropped out. The trial was looking at a treatment called "Neubie" (a type of electrical stimulation device) and measured three things: a standard disability score used in MS called the Expanded Disability Status Scale (EDSS, where higher numbers mean greater disability), a 12-question self-reported walking scale (where a lower change score suggests less walking difficulty), and a muscle strength test across different muscle groups in the body. The reported data shows that on the EDSS disability scale — which runs from 0 to 10 — the group's average score was 6.8 at both the first and final assessments, and the neurologist reported no change in any participant's score between the two time points. For the walking scale, which converts answers into a score out of 100 (where a drop in score suggests walking became less limited), two figures were reported: 0.89 and 0.7 — though it is not entirely clear from the submitted data whether these represent scores at different time points or different calculations. For the muscle strength test, a series of individual muscle group scores were reported across two sets of measurements, with values ranging from 3 to 7 on a 12-point scale used for data entry purposes. No overall summary figures (such as averages or changes over time) were provided for the muscle strength results beyond these individual scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05131971 · results posted 26 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 54 people in total. Fifteen participants received a placebo (an inactive treatment used for comparison), while the remaining 39 received one of seven different dose levels of the investigational medicine GSK3888130B — some given through a drip into the vein (IV) and some by injection under the skin (SC). All 54 participants who started the trial completed it. The trial was primarily focused on monitoring and counting any medical events or changes in blood and urine test results that occurred during the study period. The reported data shows that when it came to general medical events (called adverse events), 8 out of 15 placebo participants experienced at least one, while the numbers across the seven GSK3888130B dose groups ranged from 2 to 8 participants out of their respective group sizes. No serious adverse events — defined as those involving hospitalisation, being life-threatening, causing lasting disability, or resulting in death — were reported for any participant in any group, based on the data submitted. For blood count changes (haematology) and blood chemistry results, zero participants in any group were recorded as having a clinically significant change. A kidney marker called creatinine showed a Grade 1 increase (a mild worsening from their starting level) in 1 participant in Dose Level 6 IV, and zero in all other groups. Some shifts in a specific immune cell count (CD4+ T cells) and in urine test results were also tracked, with small numbers of participants across various groups showing changes, as noted in the detailed data — though the data for the higher grade categories in several measures was not fully reported in the submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04261790 · results posted 17 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people with multiple sclerosis (MS), and all 10 completed the study — none dropped out. The trial was looking at what happens in the immune system before and after participants received a medicine called ocrelizumab. Specifically, researchers wanted to track changes in certain immune cells (called B-cells and T-cells) and the chemical signals they produce, to better understand how the treatment interacts with the immune system. The reported data shows that for all five of the trial's primary (main) outcome measures — which covered changes in immune cell types and the inflammatory and anti-inflammatory signals they produce — no numerical results were submitted to ClinicalTrials.gov. The data for those measures was not reported, so it is not possible to describe what those findings were. For the one secondary (additional) outcome measure, researchers tracked how many participants showed a return of MS disease activity after the third month following their first infusion (measured by brain scan changes or a confirmed relapse). The reported data shows that out of 10 participants, 0 showed a return of disease activity by that measure. It is important to note that because the primary outcome numbers were not reported, a full picture of what the trial found is not available from this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03853746 · results posted 5 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 people, all of whom received a treatment called ocrelizumab. Nine participants completed the study, and one did not. The trial was looking at whether signs of multiple sclerosis (MS) activity returned after the third month following the first infusion. This was checked either by finding new or growing areas of concern on MRI brain scans, or by a clinical relapse — meaning a return of MS symptoms confirmed by a neurological examination. The reported data shows that, out of the 10 participants, 3 showed a return of disease activity in one measurement period and 6 showed a return in another measurement period (the data as submitted lists two separate figures for this primary outcome, though no further breakdown of these two figures was provided). For the secondary outcomes, the reported data shows a very small average change in disability scores — measured using a scale called the EDSS, where higher numbers mean greater disability — of minus 0.009 points per month over the study period. Separately, a fatigue-related quality of life score (where a higher score means more fatigue) changed by minus 0.012 points per month on average. These are very small numerical changes, and the data does not include information about what would be considered a meaningful difference on these scales. It is worth noting that this was a very small study of only 10 people, which limits how much can be drawn from the numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03046251 · results posted 22 January 2025
According to the results reported on ClinicalTrials.gov, this trial followed 30 people with multiple sclerosis (MS) in the period after giving birth — 4 in the natalizumab group and 26 in a control group who were on other MS treatments. All 30 participants completed the study. The trial was measuring how often relapses (flare-ups of MS symptoms) occurred in the year after delivery, and also tracked changes in disability levels, brain scan findings, and quality of life over roughly 52 weeks. The reported data shows that, for the main thing being measured — relapses in the year after birth — 2 out of 4 participants in the natalizumab group had a relapse, compared with 7 out of 26 in the control group. For the number of participants who remained relapse-free, the data reports 2 out of 4 in the natalizumab group and 17 out of 26 in the control group. Regarding disability (measured on a standard 0–10 scale called the EDSS, where higher numbers mean greater disability), the reported average score at around week 52 was 1.8 in both groups. No participants in the natalizumab group showed a worsening of their disability score, compared with 4 out of 26 in the control group. For brain scan (MRI) changes, the reported data shows 3 natalizumab participants and 5 control participants had new or growing lesions visible on one type of scan, and 1 natalizumab participant and 3 control participants had new lesions visible with contrast dye. Quality of life questionnaire data was collected from 3–4 natalizumab participants and 9 control participants across the different questionnaires, though detailed scores for those measures were not reported in the submitted data. It is worth keeping in mind that this was a very small trial — particularly the natalizumab group with only 4 participants — which means the numbers on their own are difficult to interpret broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05028634 · results posted 22 January 2025
According to the results reported on ClinicalTrials.gov, this trial involved 63 participants in total — 30 in the ozanimod group and 33 in the comparison group (people not taking ozanimod). Ozanimod is a medicine used for certain conditions, and the trial was looking at how well participants' immune systems responded to two vaccines — a tetanus booster and a pneumococcal (pneumonia-related) vaccine — while on or off this medicine. All but one participant completed the study. The reported data shows some differences between the two groups in how their bodies responded to the tetanus booster vaccine. When looking at whether participants mounted a strong enough immune response (meaning their antibody levels — proteins the body makes to fight infection — rose to a defined threshold), 10% of those in the ozanimod group met that response criteria, compared with 53.1% in the non-ozanimod group. However, when simply looking at whether participants had a baseline level of antibody considered protective against tetanus, 100% of both groups met that lower bar. For the pneumococcal vaccine, 69% of the ozanimod group and 87.5% of the non-ozanimod group showed a meaningful antibody response, while 66.7% and 71.9% respectively reached the defined protection level across the targeted strains. The reported data also shows that 11 participants in each group experienced adverse events (unwanted health occurrences recorded during the study period), and no serious adverse events — meaning events such as hospitalisation or life-threatening reactions — were recorded in either group. Some blood chemistry abnormalities (unusual results in blood tests) were noted in both groups, though the specific breakdown across different categories was not fully labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04783935 · results posted 22 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04783935) enrolled 219 adults with multiple sclerosis (MS) who were all treated with a medicine called cladribine. Of those, 206 people completed the study and 13 did not. The trial was an extension study — meaning participants had already been in an earlier ("parent") trial — and it followed them through years 3 and 4 of their overall treatment journey. The main thing researchers were tracking was called "NEDA-3," or "No Evidence of Disease Activity" across three measures: no relapses (flare-ups), no worsening of disability (measured on a standard MS scale called EDSS, which runs from 0 meaning no disability to 10), and no new signs of disease visible on MRI brain scans. The reported data shows that for the primary outcome — whether participants showed no evidence of disease activity across the whole of years 3 to 4 combined — approximately 54% of participants met that standard, based on a statistical method used to account for missing data over time. For the secondary outcomes, the reported data shows that at year 3 alone, around 82% of participants showed no evidence of disease activity, and at year 4 alone, around 79% did. When researchers looked back across the full four years from the very start of the parent study, the proportion showing no evidence of disease activity throughout dropped to approximately 32% by the end of year 3, and around 27% by the end of year 4. Among those who had shown no evidence of disease activity during years 1 and 2, the reported data shows that a higher proportion — ranging from around 83% to 93% depending on the specific timepoint — continued to show no evidence of disease activity into years 3 or 4. The reported median time to a first sign of any disease activity during the extension period (years 3–4) was approximately 24 months, while across the full four-year period it was reported as approximately 6 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03085810 · results posted 15 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT03085810) involved a single treatment group receiving ocrelizumab, a medicine used in multiple sclerosis. A total of 1,225 people began the main part of the study, of whom 1,010 completed it. A separate sub-study ran alongside the main study, looking at two different ways of giving the infusion (a conventional infusion and a shorter infusion), with 373 people in each of those two groups. The trial was mainly tracking changes in participants' disability levels over time, using a standard scale called the EDSS (which runs from 0, meaning no disability, to 10). Specifically, it measured how many people experienced worsening disability that lasted at least 24 or 48 weeks, and how many showed confirmed improvement in their disability score. The reported data shows that, during Year 1, between approximately 97% and 99.6% of participants did not experience confirmed disability worsening lasting 24 or 48 weeks, depending on the specific time point measured. For disability improvement (defined as a meaningful reduction on the EDSS score sustained over time), the reported figures ranged from around 83.5% to 95.1% at Year 1, and from approximately 90% to 100% at Years 2 and 4, again varying by the specific time point and threshold used. For the primary outcome measuring the overall time until disability worsening first occurred, the reported data shows the value was listed as "not available," meaning that particular result was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04574024 · results posted 17 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04574024) involved people with multiple sclerosis (MS) who were given a treatment called NBT-NM108. Seven participants were enrolled at the start of the study. Of those, three went on to take NBT-NM108 for eight weeks, and two continued for twelve weeks. The trial was measuring three things in the blood and stool: levels of a protein called TNF-alpha (which is linked to inflammation in MS), the abundance of a type of gut bacteria called *Anaerostipes* (which tends to be lower in people with MS), and levels of a stool marker called Lcn-2 (which can indicate an imbalance in gut bacteria). The reported data shows the following numbers across the three time points — before treatment (baseline), after eight weeks, and after twelve weeks. For TNF-alpha, measured in picograms per millilitre (a very small unit of concentration), the reported figures were 25.62 at baseline, 22.58 at eight weeks, and 20.73 at twelve weeks. For *Anaerostipes* gut bacteria, measured as a percentage of all bacteria present, the reported figures were 1.94% at baseline, 4.23% at eight weeks, and 4.52% at twelve weeks. For the stool marker Lcn-2, measured in nanograms per milligram, the reported figures were 68.7 at baseline, 24.4 at eight weeks, and 33.4 at twelve weeks. No additional context or comparison figures were provided in the submitted data beyond these numbers. It is worth noting that this was a very small study with only seven participants at the start and fewer at later time points, and no other outcome data beyond these three measures was reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04486716 · results posted 1 November 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04486716) enrolled 111 participants, all of whom received a treatment called ofatumumab at a dose of 20 mg. Of those, 102 were included in the main analysis, and 89 completed the core phase of the study. The trial was primarily looking at whether brain scans showed no increase — or a reduction — in a type of inflammation marker called gadolinium-enhancing lesions (bright spots visible on a specialised MRI scan that can indicate active inflammation in the brain) after 12 months of treatment. The reported data shows that, using a conservative counting method (where anyone who missed their 12-month scan was counted as not achieving the target), 86.6% of participants showed no increase or a reduction in these brain scan markers at month 12. When the analysis was restricted only to participants who actually had a valid 12-month scan, the reported figure was 100%. For secondary measures, the reported data shows that 95 participants were still on treatment at month 6, and 89 at month 12. The trial also measured levels of certain immune cells in the blood (CD19+ B cells and CD20+CD3+ T cells); both types showed a reported reduction from the starting levels at both 6 and 12 months, though the exact clinical meaning of these changes is not described in the submitted data. Additionally, a standard questionnaire about thoughts of self-harm (the C-SSRS) was used throughout the study; the reported data shows that some participants answered "yes" to items on this questionnaire both at the start and during the study, but no further breakdown of what this means in context was provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05422625 · results posted 9 October 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05422625) was designed to compare two versions of a nerve stimulation treatment — an active version (called PTNS, or percutaneous tibial nerve stimulation) and a sham (inactive/pretend) version — for bladder overactivity symptoms in people with multiple sclerosis (MS). The trial aimed to enrol participants in both groups, but the reported data shows that only 2 people were enrolled in the active treatment group and none in the sham group. Of those 2, only 1 person completed the trial. No results were reported for the sham group at all. The reported data shows the following numbers for the single participant who completed the active treatment arm. On the main outcome — a self-rated questionnaire called the PGI-I, where 1 means "very much better" and 7 means "very much worse" — that participant scored a 4, which on this scale means "no change." For the diary-based measures tracked over three days, the participant recorded 1 more toilet visit (void) than before treatment, 1 more urgency episode (a sudden strong urge to urinate), but 3 fewer leakage episodes (urgency incontinence). On a bladder quality-of-life questionnaire (scored 0–166.6, where lower means fewer symptoms and better quality of life), the participant's score went down by 47.69 points from their starting score, where a negative number indicates a move toward improvement on that scale. It is important to understand that these numbers come from just one person, which means no meaningful conclusions about the treatment can be drawn from this trial. The reported data shows the trial did not complete as planned. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04754542 · results posted 25 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04754542) was an extension study that followed on from an earlier trial. A total of 76 people took part — 31 in a group that continued their disease-modifying medication and 45 in a group that stopped (discontinued) their medication. The trial was mainly measuring how many participants in each group showed signs of new inflammatory disease activity — meaning either a clinical relapse (a flare of symptoms) or a new lesion detected on a brain or spinal cord scan (MRI). The reported data shows that, for the primary outcome, 2 out of 45 participants in the discontinuation group showed new inflammatory disease activity, compared with 1 out of 31 in the continuation group. For the secondary outcome, which tracked changes in disability using a standard rating scale called the EDSS (scored from 0 to 10, where higher scores mean more severe disability), the reported data shows the continuation group had an average change of 0 points from their original starting score, while the discontinuation group had an average change of 0.10 points — both very small numbers on that scale. The trial also collected participants' own ratings of things like arm and leg function, fatigue, and sleep disturbance using standardised quality-of-life questionnaires; the changes reported across both groups in all of these measures were small (ranging from approximately −0.6 to +0.6 on a standardised scale), though no further breakdown of what those numbers mean in practical terms was provided in the reported data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03157830 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people who had been taking a MS medication called natalizumab and then switched to a different MS medication called ocrelizumab (brand name OCREVUS). Forty-one of the 43 participants completed the study. The trial was measuring how many participants remained free of MS relapses (episodes of worsening symptoms) over 12 months after switching, as well as tracking brain scan changes and a disability score over that same period. The reported data shows that at the 12-month mark, 95.2% of participants had not experienced a relapse. Looking at earlier time points, 100% were relapse-free at both 3 and 6 months, and 97.67% at 9 months. For brain scan (MRI) results, the reported data shows that 92.31% of participants showed no sign of MS disease activity on their scans at the 3-, 6-, and 12-month checks. Regarding specific scan findings called "new or enlarging T2 lesions" (areas on the brain scan that can indicate MS activity), 4.65% of participants had these at 3 months, and none were detected at 6 or 12 months. Similarly, another type of scan finding called "Gd+ lesions" (spots that can show active inflammation) were present in 5.13% of participants at 3 months, and none at 6 or 12 months. A disability rating scale called the EDSS (where 0 means no disability and 10 means the most severe) was measured at the start and end of the study — the reported average score was 3.50 at both time points, meaning no average change in that score was reported over the 12 months. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04667117 · results posted 1 August 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04667117) enrolled 63 participants across three groups: Cohort 1 (22 people), Cohort 2 (22 people), and Cohort 3 (19 people). The trial was studying an influenza vaccine and measuring whether participants developed a level of immune response — specifically, a blood antibody level — considered to indicate protection against ten different influenza strains. The trial also had an extension period that Cohort 1 and Cohort 2 (but not Cohort 3) continued into. The reported data shows that the primary measure was the percentage of participants reaching a target antibody level (called "seroprotection") four weeks after vaccination, checked against ten influenza strains. When looking only at participants who had available data, 100% of participants in all three cohorts reached that target level for most of the strains tested, with two exceptions: for one strain, the figures were 80% (Cohort 2) and approximately 86% (Cohort 3). When a more conservative calculation was used — counting anyone with missing data as not having responded — the percentages were lower, ranging from roughly 56% to 100% depending on the cohort and the strain. For the secondary measure of "seroconversion" (a meaningful jump in antibody levels from before to after vaccination), the reported percentages varied widely across cohorts and strains, from 0% to 100%. The reported data also shows that 16 participants in Cohort 1, 6 in Cohort 2, and 2 in Cohort 3 experienced adverse events (unexpected health changes noted during the study); no participants discontinued due to an adverse event; and one participant in Cohort 2 experienced a serious adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03200899 · results posted 10 July 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 183 people with multiple sclerosis (MS) — 93 in a cognitive rehabilitation programme called MAPSS-MS (Memory, Attention, Problem Solving Skills in MS) and 90 in a comparison group that received usual care plus computer games. The trial measured several aspects of thinking and memory, including how well participants could learn and recall words, how often they used strategies to help their memory, how well they solved everyday problems, their confidence in managing situations, their ability to quickly find words, and their non-verbal (visual) memory. The reported data shows the following scores at the end of the study. For word learning and recall (out of a possible 80), the MAPSS-MS group scored 56.1 and the comparison group scored 53.6. For use of memory strategies (out of 76), scores were 40.2 and 39.5 respectively. For everyday problem-solving (out of 30), scores were 24.2 versus 23.5. On the secondary measures, confidence in managing situations (out of 85) was reported as 63.7 for MAPSS-MS and 61.1 for the comparison group; word-finding (number of words generated) was 39.5 versus 36.9; and visual memory (out of 36) was 21.9 versus 20.1. The reported data shows that scores across all measured areas were numerically similar between the two groups, with the MAPSS-MS group recording slightly higher figures on each measure. The data as submitted does not include information about whether these differences were considered statistically meaningful (that is, unlikely to be due to chance), so that context was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05062083 · results posted 27 June 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 5 people diagnosed with multiple sclerosis (MS), and all 5 completed the study. The trial was investigating two special imaging tracers — called [¹¹C]PS13 and [¹¹C]MC1 — that are used with a type of brain scan known as a PET scan. The goal was to measure how much of each tracer was taken up in MS-related brain lesions (areas of damage in the brain) compared to surrounding brain tissue. The researchers used a figure called a Standard Uptake Value Ratio (SUVR), which is simply a number representing how much tracer collected in the lesion area relative to a reference region of healthy brain tissue — a higher number means more tracer was detected in the lesion area. The reported data shows that when using the [¹¹C]PS13 tracer, the SUVR for brain lesions was reported as 1.380 (for lesions) and 1.408 (for the mirror-image tissue on the opposite side of the brain). For the [¹¹C]MC1 tracer, the reported SUVR figures were 1.455 (lesions) and 1.594 (opposite-side tissue). When looking specifically at a particular type of lesion called "chronic active lesions," the reported SUVR figures were 1.424 and 1.455 for [¹¹C]PS13, and 1.562 and 1.724 for [¹¹C]MC1. Two additional measurements were planned — repeating the scans after giving participants a blocking medication (ketoprofen for one tracer, celecoxib for the other) — however, the reported data shows those results were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT05119569 · results posted 12 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05119569) looked at a drug called fenebrutinib in people with a condition affecting the brain and nervous system. The trial had two stages. In the first stage — a double-blind phase, meaning neither participants nor researchers knew who received which treatment — 73 people received fenebrutinib and 36 received a placebo (a dummy treatment with no active ingredient) for 12 weeks. The main thing being measured was the rate of new brain lesions (areas of damage or inflammation) visible on MRI scans, specifically a type called "gadolinium-enhancing T1 lesions," which show up when a special dye is used during the scan. After completing the first stage, participants moved into an open-label extension phase, where all 99 continuing participants received fenebrutinib — but no results from that phase were reported in this data. The reported data shows that, over the 12-week double-blind period, the fenebrutinib group had an adjusted average of 0.077 new lesions per MRI scan, compared with 0.245 in the placebo group for the primary measure. For a secondary MRI measure — looking at lesions that were new or had grown on a different type of scan (T2-weighted) — the reported rates were 0.168 per scan for fenebrutinib and 0.634 for placebo. The reported data also shows that approximately 72.9% of participants in the fenebrutinib group had no new lesions of either type detected across the 12 weeks, compared with 50.0% in the placebo group. Regarding unwanted medical events (called adverse events), 28 out of 73 people in the fenebrutinib group and 12 out of 36 in the placebo group experienced at least one such event during the double-blind phase; no serious adverse events were reported in either group during that phase. Data for the open-label extension phase and for suicidal ideation assessments were listed as outcome measures but were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02688985 · results posted 4 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02688985) enrolled 131 people in total across five groups. There were four groups of people with relapsing multiple sclerosis (RMS) — 23, 31, 28, and 18 participants respectively — and one group of 31 people with primary progressive multiple sclerosis (PPMS). All participants received the drug ocrelizumab alongside a lumbar puncture (a procedure to collect fluid from around the spine). The trial was measuring changes in three things found in that spinal fluid: a protein called neurofilament light (NfL, which can be a marker of nerve cell stress), and two types of immune cells — CD19+ B cells and CD3+ T cells. Each group was measured at different time points ranging from 12 weeks to 52 weeks after starting treatment. It is worth noting that across all five groups, only one participant was recorded as having completed the study, while the rest did not complete it — this context is important when considering the reported numbers. The reported data shows the following changes from the starting (baseline) measurements. For the NfL protein (measured in picograms per millilitre, pg/mL), the four RMS groups showed reductions ranging from approximately −932 to −1,233 pg/mL at their primary time points, while the PPMS group showed a reported increase of about +262 pg/mL at its primary time point. For CD19+ B cells (a type of immune cell, measured per microlitre of fluid), the reported changes at the primary time points were small reductions across most groups, ranging from roughly −0.09 to −0.22 cells/μL, with the exception of one RMS group (Arm 4 at a later time point) which showed a small increase of +0.15 cells/μL. For CD3+ T cells (another type of immune cell), the reported changes at primary time points were also small, ranging from approximately −1.46 to −6.61 cells/μL reductions across groups, though some groups showed small increases at later time points. Some measurements across the later follow-up time points were not reported for all groups in the data submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04389970 · results posted 27 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04389970) looked at a dietary approach called Time Restricted Feeding — where people limit the hours of the day during which they eat — over an 8-week period. Twelve people enrolled in the study, and eleven completed it; one person did not finish. The trial measured walking speed as its main outcome, and also tracked self-reported pain, fatigue, sleep quality, and body composition as secondary outcomes. The reported data shows that for walking speed — measured using a standard 25-foot walk test — the average change from the start to the end of the 8 weeks was −0.3 feet per second. Because the change scores here were calculated as the starting value minus the end value, a negative number means participants were walking slightly slower on average at 8 weeks than at the start. For the pain questionnaire (scored 0–45, where higher means more pain), the reported change was −1.9, meaning scores were slightly lower at 8 weeks. For the two fatigue questionnaires, one (the Modified Fatigue Impact Scale, scored 0–84) showed a change of −1.3, while the other (the Fatigue Severity Scale, scored 9–63) showed a change of +2.3 — again, because of the way changes were calculated (baseline minus end), a positive number here means scores were slightly lower at 8 weeks. For sleep quality (scored 0–21, where higher means poorer sleep), the reported change was +0.2, meaning scores were very slightly lower at 8 weeks. The reported change in lean body mass as a percentage of total body weight was 0, meaning no average change was recorded. It is worth noting that this was a small study with only 12 participants and no comparison group, which limits what can be concluded from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03745144 · results posted 15 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03745144) looked at whether cladribine — a medicine used for multiple sclerosis — affects the way the body absorbs hormones from a common oral contraceptive pill called Microgynon (which contains two hormones, ethinyl estradiol and levonorgestrel). The trial had three groups: 28 people took Microgynon alone during a run-in period, and then 24 of those participants moved into the main part of the trial, split into two sequences — one group took cladribine with Microgynon first, then switched to a placebo (a dummy treatment) with Microgynon; the other group did the reverse. In total, 23 participants completed both periods of the main trial. The reported data shows that the trial measured several things about how much of each hormone appeared in the blood over time — including the total amount absorbed, the highest level reached, the lowest level, the level at the end of each dosing period, the average level, and how quickly the peak level was reached. For ethinyl estradiol, the reported numbers when taken with cladribine versus placebo were very similar across all these measures: for example, the total amount absorbed (AUCt,ss) was 789 versus 817 (in standard measurement units), the peak blood level was 88.3 versus 88.1, and the lowest level was 14.8 versus 14.7. For levonorgestrel, the figures were also close: total absorption was 91,400 versus 92,000, peak level was 7,950 versus 8,150, and lowest level was 2,520 versus 2,430. In both cases, the time to reach the peak blood level was reported as 1.00 hour in both the cladribine and placebo conditions. The reported data shows that these numbers were measured and recorded as the primary focus of the trial — they describe the hormone levels in the blood under each condition, not a clinical health outcome. What these figures mean in a broader medical context was not described in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04175834 · results posted 4 March 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 people in total — 9 in a group that received diphenhydramine (an older antihistamine, sometimes known by the brand name Benadryl) and 10 in a group that received cetirizine (a newer antihistamine, sold as Zyrtec or Zilarex in Australia) — as pre-medications before receiving infusions of a drug called ocrelizumab. The trial was measuring how many participants in each group experienced an "infusion-related reaction" (that is, an unwanted body response during or shortly after the drip) at three different time points, and also how participants rated their sleepiness, fatigue, and overall satisfaction with their medication experience. The reported data shows that on the first infusion day (Day 0), 5 out of 9 participants in the diphenhydramine group and 6 out of 10 in the cetirizine group had a reported infusion-related reaction. At the second infusion visit (Day 14), the numbers were 6 out of 8 completers in the diphenhydramine group and 8 out of 10 in the cetirizine group. At the later visit around week 24 (Day 168), it was 7 out of 8 and 8 out of 10 respectively. For sleepiness (scored 1–7, where higher means sleepier), the diphenhydramine group consistently reported higher scores (around 3.1) compared to the cetirizine group (around 1.9–2.3) across the three visits. For fatigue, the reported data shows mixed results across the two subscales and visits, with no single clear pattern between the groups. Satisfaction scores (0–100, where higher means more satisfied) were broadly similar between groups, with the cetirizine group reporting slightly higher scores at most time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03396822 · results posted 5 February 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03396822) enrolled 23 people with multiple sclerosis (MS) who were treated with a medicine called ocrelizumab. Of those 23 participants, 14 completed the study and 9 did not. The trial was measuring changes in something called "leptomeningeal enhancement" — bright spots seen on a specialised brain scan that can indicate inflammation in the layers of tissue surrounding the brain. The focus was on participants who already showed these bright spots at the start of the study (referred to as "baseline"). The reported data shows the following results, all measured only in the subgroup of participants who had these scan findings at the beginning of the trial. For the main (primary) outcome — the change in the number of these bright spots after one year of treatment — the reported figure was 0.07, meaning the average number of spots was almost unchanged from where it started. For one of the secondary outcomes, 8 participants were reported as having meningeal (brain lining) enhancement after treatment. For an additional pre-specified outcome, the reported data shows a change of −21.9 mm³ in the total volume (size) of these areas of contrast on the scan, indicating the volume was smaller at follow-up compared to the start — though the data does not report how many participants this figure is based on beyond the subgroup already described. It is important to note that this was a single group study with no comparison group, and the number of participants was small, which limits what can be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03824938 · results posted 27 October 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people across six groups, each of which took the three study treatments — a placebo (a dummy pill with no active ingredient), aspirin, and acetaminophen (a common pain reliever also known as paracetamol) — in a different order. In total, 29 participants completed the study. The trial was measuring two things during a cycling exercise test taken to the point of exhaustion: how long each person could keep exercising, and how much their body temperature changed from before to after that test. The reported data shows that, on average, participants exercised for about 552 seconds (roughly 9 minutes) after taking the placebo, about 332 seconds (roughly 5.5 minutes) after taking aspirin, and about 578 seconds (roughly 9.6 minutes) after taking acetaminophen. For body temperature change, the reported data shows an average rise of about 0.68 degrees Fahrenheit after placebo, 0.006 degrees Fahrenheit after aspirin, and 0.31 degrees Fahrenheit after acetaminophen. These numbers describe what was recorded and reported — they do not on their own explain why the differences occurred or what they mean in a broader sense. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03574610 · results posted 5 October 2023
According to the results reported on ClinicalTrials.gov, this trial enrolled 11 people with multiple sclerosis (MS) who also had bladder and urination difficulties. Ten participants completed the study, and one did not finish. The trial was testing a device called a Transcranial Rotating Permanent Magnet Stimulator (TRPMS) — a non-invasive machine that applies a rotating magnetic field to the head. The main thing researchers were measuring was whether brain activity related to bladder control changed after using the device, using a type of brain scan called a functional MRI (fMRI), which tracks blood flow as a sign of brain activity. They also measured a range of bladder-related outcomes before and after treatment, including how much urine was left in the bladder after going to the toilet, how fast urine flowed, and how participants rated their own urinary symptoms. The reported data shows that, for the primary brain scan measure, the researchers used a "T-value" to judge whether brain activity increased or decreased — values above 2.074 were defined as showing an increase in activity. The reported T-values across the 12 brain regions or time-points measured ranged from approximately 2.76 to 5.52, all above that 2.074 threshold. For the bladder measurements, the reported data shows figures for urine volume left after voiding, total voided volume, and bladder capacity at different time-points (baseline and after treatment), with values ranging from roughly 98 mL to 381 mL across those measures. The reported percentage of urine remaining after voiding relative to bladder capacity was 54% at one time-point, 29% at another, and 42% at a third. Peak urine flow rate was reported as 22.2, 31.0, and 25.5 mL per second across the time-points. On the self-reported symptom questionnaire (scored 0–4 per question, where higher means worse symptoms), the reported scores across the measured questions and time-points ranged from approximately 1.38 to 3.30. The reported data does not include clearly labelled before-and-after comparisons for every measure, so direct comparisons between time-points cannot be described with certainty from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03658668 · results posted 16 August 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03658668) involved 22 people in total — 13 in a group receiving active brain stimulation (called tDCS) combined with physical activity, and 9 in a group receiving a "sham" (inactive/pretend) version of the same brain stimulation also combined with physical activity. Most participants finished the trial: 12 from the active group and 8 from the sham group. The trial was measuring changes in how people walked — specifically their walking speed and stride length — as well as how they felt about the impact of their condition on walking and fatigue levels. The reported data shows that, for walking speed, the active tDCS group had an average increase of 0.33 metres per second, while the sham group had an average increase of just 0.01 metres per second. For stride length, the active group showed an average increase of 0.32 metres, while the sham group showed a very small average decrease of 0.02 metres. On a questionnaire asking participants how much their condition affected their walking (scored from 12 to 60, where higher means greater impact), the active group's average score went down by 4.9 points and the sham group's went down by 2.5 points — meaning both groups reported some reduction in walking impact. On a fatigue questionnaire (scored 0 to 84, where higher means more fatigue impact), the active group's average score went down by 12.4 points, while the sham group's average score went up by 1.6 points. The reported data also shows that all participants in both groups completed 100% of their scheduled brain stimulation sessions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04657666 · results posted 20 July 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04657666) involved 68 people in total, split into two groups in a "crossover" design — meaning each person received both the active treatment (nabiximols, a cannabis-based mouth spray) and a dummy treatment (placebo) at different points in the trial, just in different orders. The trial was measuring changes in lower limb muscle stiffness (sometimes called spasticity) using a standard rating scale, as well as a number of other measures including blood pressure, heart rate, and weight. The reported data shows that the primary measure — a combined score of muscle stiffness across six muscle groups in the legs, rated on a scale from 0 to 5 — changed by an average of −0.23 points for people when taking nabiximols, and −0.26 points when taking the placebo. A negative number means the score went down (i.e. towards less stiffness) from the starting point. A similar pattern was seen for a related four-muscle-group score, where nabiximols showed a change of −0.23 and placebo showed −0.28. The reported data also shows that 27 participants experienced at least one adverse event (an unwanted or unexpected health change) while taking nabiximols, compared with 15 while taking placebo. Small changes in blood pressure, heart rate, and weight were also recorded in both groups, as shown in the submitted data. It is worth noting that in a crossover trial like this, some results — such as the adverse event counts — can be influenced by the fact that participants took both treatments at different times. The reasons behind any of the numbers reported are not explained in the submitted data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT04115488 · results posted 3 July 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04115488) enrolled 264 people in total — 131 received PB006 (an investigational treatment being compared to an existing medicine called Tysabri/natalizumab) and 133 received Tysabri. At the halfway point (week 24), some participants in the Tysabri group were re-assigned: 30 were switched to PB006 and 95 continued on Tysabri. By the end of the study, 117 people in the PB006 group and 122 in the Tysabri group had completed the trial. The main thing the trial was measuring was the number of new active brain lesions spotted on MRI (brain scans) over 24 weeks — lesions are areas of inflammation or damage sometimes seen in conditions like multiple sclerosis. The reported data shows that, over the first 24 weeks, the average cumulative (total built-up) number of new active lesions was 1.4 in the PB006 group and 1.9 in the Tysabri group (these figures come from the "per-protocol" analysis, meaning participants who followed the study plan closely). Over the full 48 weeks, the reported data shows an average of 1.5 new active lesions for PB006 and 2.3 for Tysabri. For a more specific type of lesion seen on MRI (called gadolinium-enhancing T1 lesions — bright spots that can indicate active inflammation), the reported averages were very similar between the groups: roughly 0.3 lesions for PB006 and 0.4 for Tysabri, at both 24 and 48 weeks. In terms of how many individual participants had none of these specific lesions over 48 weeks, the reported data shows 105 out of the PB006 group and 80 out of the Tysabri group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03621761 · results posted 27 December 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 336 people in total across three groups: 114 received Cognitive Behavioural Therapy (CBT, a talking-based treatment), 114 received a medication called modafinil, and 108 received both treatments combined. The trial was measuring fatigue — specifically how much fatigue affected participants' daily lives and activities — in people who took part over a 12-week period. The vast majority of participants who started the trial completed it, with only 3–4 people dropping out in each group. The reported data shows that the main thing being measured was a fatigue questionnaire called the Modified Fatigue Impact Scale, scored from 0 to 84, where higher numbers mean fatigue is having a bigger impact on daily life. According to the results reported on ClinicalTrials.gov, all three groups reported lower scores at 12 weeks compared to where they started: the CBT-only group's average score dropped by 15.2 points, the modafinil-only group's dropped by 16.0 points, and the combined group's dropped by 17.3 points. The reported data shows that participants in all three groups also self-reported reductions in how intense their fatigue felt (on a 0–10 scale, drops ranged from 1.41 to 2.03 points) and in how much fatigue interfered with their activities (drops ranging from 1.41 to 1.78 points). A separate measure of "fatigability" — a ratio combining fatigue ratings with physical activity levels — also showed reductions across all groups, though the numbers reported were small in scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03808545 · results posted 18 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03808545) enrolled 11 people in total, split across two groups: one group (6 people) took part in a programme called BIPAMS, and the other group (5 people) took part in BIPAMS combined with a diet programme. The trial ran for 16 weeks and was measuring changes in body composition and certain health markers — specifically BMI (a number calculated from height and weight), waist size, body fat, blood pressure, and blood sugar levels. The reported data shows the following changes from the start of the trial to week 16. For BMI, the BIPAMS-only group had a reported change of +0.60 kg/m², while the BIPAMS-plus-diet group had a change of +0.49 kg/m². Waist circumference changed by +0.31 cm in both groups. For body fat (measured in pounds), the BIPAMS-only group showed a change of +2.14 lb, while the BIPAMS-plus-diet group showed a change of +0.05 lb. For the secondary measures, diastolic blood pressure (the lower number in a blood pressure reading) changed by −2.20 mmHg in the BIPAMS-only group and 0.00 mmHg in the combined group. Systolic blood pressure (the upper number) changed by −6.20 mmHg and −4.25 mmHg respectively. Blood sugar levels changed by −3.40 mg/dl in the BIPAMS-only group and 0.00 mg/dl in the combined group. It is worth noting that the trial started with very small numbers — only 9 of the 11 participants completed the study — so the reported figures come from a very small group of people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01970410 · results posted 20 October 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT01970410) looked at a medicine called teriflunomide in people with multiple sclerosis (MS) who had previously been treated with a different MS medicine called natalizumab. The main part of the study started with 55 participants, of whom 28 completed it. A separate sub-study, which looked at a specific antibody marker related to a virus associated with natalizumab use, started with 41 participants and 36 completed it. The trial tracked things like whether participants had MS relapses (sudden worsening of symptoms) over 24 months, changes visible on brain scans, and changes in disability levels. The reported data shows that in the main study, 25 out of 55 participants were free from relapses at the 24-month mark. For the brain scan measures, the reported average time until new areas of inflammation first appeared on scans (called "gadolinium-enhancing lesions," which are spots that light up on a special type of MRI) was 19.6 months. The reported average time until new or growing lesions of another type (called T2 lesions, another way of spotting MS-related changes on a brain scan) appeared was 19.2 months. The reported average time until a measurable worsening in disability scores — sustained over at least three months — was 22 months. In the sub-study, 20 out of 36 participants showed a reduction of at least 20% in a particular antibody level that researchers were monitoring. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03368664 · results posted 12 July 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03368664) enrolled 16 people with multiple sclerosis (MS). The study was designed in two phases: a first phase lasting four months where participants continued on their existing MS medication, followed by a second phase lasting eight months where 11 participants received a treatment called alemtuzumab. The trial was primarily measuring changes in brain MRI scans — specifically, looking at the number of new or enlarging lesions (areas of inflammation or damage visible on the scan) over time. The reported data shows that during the first phase (on existing medication), participants had an average of 3.53 new or enlarged lesions per MRI scan, and 10 out of the participants had at least one such lesion. During the second phase (after receiving alemtuzumab), the reported average was 0.13 new or enlarged lesions per MRI scan, with 3 participants showing at least one such lesion. The reported data also shows a small change in disability scores (measured on a standard MS scale from 0 to 10) of +0.05 points at the four-month mark and 0.00 points at eight months, meaning little to no change from the starting score was recorded. Several other planned measurements — including relapse rates, side effects, and thinking and memory tests — were not included in this results posting and are expected to be reported later, in December 2026. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02634307 · results posted 24 June 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT02634307) enrolled 1,057 people in total across three groups: 593 who were new to the study drug ALKS 8700 (also called monomethyl fumarate), 239 who had already been taking ALKS 8700 in an earlier study and continued here, and 225 who had previously been taking a related medicine called dimethyl fumarate (DMF) and switched across. The trial was primarily measuring a range of safety-related observations — including how many participants experienced medical events or serious medical events, changes in heart rate and blood pressure, heart rhythm readings, suicidal thoughts (using a standard rating scale), and notable changes in blood test results. A relapse rate over time was also recorded. The reported data shows that when it came to medical events that started or worsened during treatment, 519 out of 593 new participants, 212 out of 239 continuing ALKS 8700 participants, and 207 out of 225 DMF-rollover participants had at least one such event recorded. Serious medical events were reported in 69, 29, and 25 participants from those same three groups respectively. For heart rate and blood pressure readings outside pre-defined normal ranges, small numbers of participants across all three groups met those thresholds — the highest single count in any sub-category was 15 participants in the new-participant group. Heart rhythm readings of potential concern were seen in 15, 5, and 6 participants across the three groups for one threshold level, and 0, 0, and 1 participants for a stricter threshold. Regarding suicidal thoughts on the rating scale, no participants in any group scored at the higher levels of concern; one participant in the new-participant group registered at the lowest category on that scale. Notable abnormalities in blood test results were seen in small numbers across all groups. The reported data also shows an annualised relapse rate — that is, the estimated number of relapses per person per year — of 0.14 for the new-participant group, 0.11 for the continuing ALKS 8700 group, and 0.13 for the DMF-rollover group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03961204 · results posted 5 May 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03961204) enrolled 662 people with multiple sclerosis (MS) in a single group, with 655 completing the study and 7 not completing it. The trial was a long-term follow-up study looking at participants who had previously received a treatment in an earlier ("parent") study. Researchers were tracking disability levels over time using a standard MS scale called the EDSS (Expanded Disability Status Scale), which runs from 0 (no disability) to 10 (death from MS). They were particularly interested in how many participants had reached higher levels of disability, and also looked at characteristics such as age, how long participants had had MS, and whether they needed additional MS medication after the parent study ended. The reported data shows that 8.2% of participants had an EDSS score of 7.0 or higher — meaning they were essentially unable to walk more than about 5 metres and were largely reliant on a wheelchair. A secondary measure found that 13.9% had an EDSS score of 6.0 or higher, meaning they needed some form of walking aid (such as a cane or crutch) to walk around 100 metres. The reported data also shows that participants were divided into "long-term responders" (those who did not need additional MS disease-modifying medication for 4 years or more after their last dose in the parent study) and "non-responders" (those who needed such medication within 4 years). Average ages reported were 50.5 and 47.1 years for these two groups respectively, with average disease durations of approximately 19.8 and 16.8 years. The reported data also shows that, before entering the parent study, both the long-term responder and non-responder groups had an average of 1.3 relapses (episodes of worsening symptoms) in the prior year. Average EDSS disability scores at the start of the parent study were reported as 2.44 for long-term responders and 2.38 for non-responders, rising to 3.23 and 3.32 respectively by the time of the first visit in this follow-up study. Some additional participant characteristic data (such as gender, race, and employment) was collected but the individual category breakdowns in the submitted data are not labelled in enough detail to describe each figure separately. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03222973 · results posted 28 April 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03222973) tested a drug called BIIB033 (750 mg) against a placebo (an inactive treatment) in people with multiple sclerosis. The trial ran in two parts. In Part 1, which lasted about 72 weeks, 131 people received placebo and 132 received BIIB033. In Part 2, which ran from around week 73 to week 168, participants continued or switched treatments — 101 people were in the group that had previously received placebo and then moved to BIIB033, and 113 people continued on BIIB033. The trial was measuring, in Part 1, how participants' overall disability changed across several tests of walking, arm function, and general disability. In Part 2, the focus shifted to recording how many participants experienced unwanted medical events (called adverse events) or serious adverse events during that period. The reported data shows that in Part 1, the overall response score — a combined measure where a positive number suggests more improvement than worsening across the tests — was −0.04 for the placebo group and +0.11 for the BIIB033 group, on a scale running from −4 to +4. For the secondary measures in Part 1, the reported data shows that 37% of placebo participants and 39% of BIIB033 participants showed a confirmed improvement in at least one of the main physical tests (walking or arm function). When a cognitive processing test was also included, 60% of placebo participants and 52% of BIIB033 participants showed improvement in at least one measure. When a different cognitive test (symbol and number matching) was added instead, the figures were 63% for placebo and 75% for BIIB033. For the measure combining improvement without any worsening across all four physical tests, 31% of placebo participants and 28% of BIIB033 participants met that threshold. In Part 2, the reported data shows that 71 out of 101 participants in the placebo-to-BIIB033 group and 76 out of 113 participants in the continuous BIIB033 group experienced at least one adverse event, while serious adverse events were reported in 9 and 2 participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03499314 · results posted 9 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03499314) involved 65 people in total — 33 in the active treatment group (called RS-tDCS Stimulation, a type of mild electrical brain stimulation) and 32 in the sham (inactive/pretend stimulation) group. The trial was measuring something called "Preload Phase Duration," which is the time it takes a person to stabilise their grip on an object after their fingers first make contact with it — essentially, how long the gripping process takes to get going. Of the 65 who started, 60 completed the study (31 in the active group and 29 in the sham group). The reported data shows that the main measurement — grip stabilisation time — was recorded in seconds for both groups. For the active stimulation group, the reported figures were 0.152 seconds and 0.163 seconds (likely reflecting two different time points or conditions). For the sham stimulation group, the corresponding figures were 0.238 seconds and 0.202 seconds. The trial data does not include further detail in the submitted results to fully explain the context of each pair of numbers, so the precise meaning of each individual figure beyond what is described above cannot be confirmed from the available data alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03567057 · results posted 18 January 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 424 people in total across three groups. One group (159 people) started on a placebo and then switched to a 274 mg dose of the study drug ADS-5102; a second group (151 people) started on a lower 137 mg dose before moving to 274 mg; and a third group (114 people) received the 274 mg dose throughout. The trial was measuring the long-term safety and tolerability of ADS-5102, as well as tracking participants' walking speed and their ability to stand, walk a short distance, and sit back down. It is worth noting that a significant number of participants did not complete the study — 95, 87, and 46 people dropped out from each group respectively. The reported data shows that the primary thing being counted was how many participants experienced adverse events (unexpected health occurrences during the trial). In the placebo-then-274 mg group, 122 out of 159 participants reported at least one adverse event. In the 137 mg-then-274 mg group, 116 out of 151 did so, and in the 274 mg throughout group, 86 out of 114 did. For the walking speed test — where participants walked 25 feet as fast as safely possible — the reported data shows speeds remained broadly similar across all three groups from the start of the study through to week 52. For the "timed up and go" test — where participants stood from a chair, walked about 3 metres, turned around, and sat back down — baseline times were around 17 seconds across groups, and at week 24 the reported times ranged from about 15 to 17 seconds across the three groups. No week 52 data for the timed up and go was reported in the data provided. The reported data covers only what was measured and counted during this trial, and the numbers above are simply the figures as submitted by the trial's sponsor. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03277248 · results posted 6 December 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03277248) enrolled 545 people with multiple sclerosis — 272 received ublituximab (given by drip into a vein) plus a dummy tablet, and 273 received teriflunomide (a tablet) plus a dummy drip. The trial ran for up to 96 weeks and was primarily measuring how often participants experienced confirmed relapses (flare-ups of MS symptoms) over time. The reported data shows that the main outcome — the annualised relapse rate, which estimates how many confirmed relapses a person would have on average over one year — was 0.091 in the ublituximab group and 0.178 in the teriflunomide group. For the brain scan (MRI) outcomes, the average number of active "enhancing" lesions (spots on the scan that can indicate new inflammation) per scan was 0.009 in the ublituximab group and 0.250 in the teriflunomide group. New or enlarging lesions averaged 0.282 per scan in the ublituximab group and 2.831 in the teriflunomide group. The reported data also shows that 43.0% of participants in the ublituximab group had "no evidence of disease activity" (meaning no relapses, no new MRI lesion activity, and no confirmed disability worsening from Week 24 to Week 96), compared with 11.4% in the teriflunomide group. Regarding thinking and processing speed (measured by a symbol-matching test), 29.0% of the ublituximab group and 31.6% of the teriflunomide group showed a meaningful decrease in score. For the measure of time to confirmed disability worsening lasting at least 12 weeks, no numerical result was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03277261 · results posted 6 December 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03277261) enrolled 549 people with multiple sclerosis — 274 received ublituximab (given by drip into a vein) plus a dummy tablet, and 275 received teriflunomide (a tablet) plus a dummy drip. The trial ran for up to 96 weeks and was primarily measuring how often participants experienced confirmed relapses (flare-ups of MS symptoms) over time. The reported data shows that for the main outcome — the average number of confirmed relapses per person per year — the ublituximab group had a reported rate of 0.076 relapses per person-year, compared with 0.188 in the teriflunomide group. For the brain scan (MRI) outcomes, the ublituximab group had an average of 0.016 active "lit-up" spots (called gadolinium-enhancing lesions) per scan, compared with 0.491 in the teriflunomide group; and an average of 0.213 new or growing lesions per scan, compared with 2.789 in the teriflunomide group. The reported data shows that 44.6% of participants in the ublituximab group showed no signs of disease activity at all (no relapses, no new MRI lesions, and no worsening of disability) between weeks 24 and 96, compared with 15.0% in the teriflunomide group. Around 29.2% of the ublituximab group and 31.8% of the teriflunomide group showed a meaningful drop in a thinking-speed test (the Symbol Digit Modalities Test) at some point during the trial. The figures for time to confirmed disability worsening were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01324232 · results posted 22 November 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 209 people with multiple sclerosis (MS) who experienced pain. Participants were divided into four groups: one group received a placebo (an inactive treatment), and three groups received different dose levels of a drug called AVP-923 (doses of 20, 30, or 45 mg). The trial's main goal was to look at whether the amount of the active ingredient dextromethorphan measured in participants' blood was linked to changes in their self-reported pain scores over the course of the study. The trial ran for roughly 12 weeks, and participants rated their pain on a scale of 0 (no pain) to 10 (worst possible pain). The reported data shows that, on average, all four groups reported lower pain scores by the end of the study compared to where they started — meaning their numbers moved in a downward direction on the 0–10 scale. The placebo group's average pain score fell by about 2.0 points, the 20 mg group by about 2.1 points, the 30 mg group by about 2.7 points, and the 45 mg group by about 1.7 points. For the secondary measures — which looked at fatigue (rated on a separate questionnaire), disability level, and quality of life related to MS — the reported data also showed small reductions (improvements in score) across all groups, though the size of the changes varied between groups and between measures. Some secondary figures were not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02451696 · results posted 1 September 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02451696) enrolled 15 people in total — 5 in the "Treated Subjects" group and 10 in the "Reference Subjects" group. Of those, 4 treated participants and all 10 reference participants completed the study; one person in the treated group did not finish. The trial was measuring whether any unwanted health events (called adverse events) occurred, as well as tracking several substances in the blood and brain tissue, including levels of a medicine called everolimus, a protein involved in blood vessel growth (VEGF), and markers of biological activity in brain tissue. The reported data shows that, for the main (primary) outcome — the number of participants who experienced an adverse event — zero participants in either group had a recorded adverse event during the monitoring period. For the secondary outcomes, blood everolimus levels were reported as 12.35 ng/ml in the treated group and 2 ng/ml in the reference group. Blood VEGF levels were reported as 56.5 pg/ml (treated) and 50.85 pg/ml (reference). A measure of a particular protein signal in brain tissue (S6 phosphate, related to a pathway called mTOR) was reported as 0.49 in the treated group and 0.81 in the reference group, using a scale relative to another protein. Finally, a measure of a brain tissue protein called HMGB1 — where a higher number means more of the protein was detected — was reported as 14.85 in the treated group and 15.06 in the reference group. It is worth noting that this was a very small trial with only 15 participants, and the results should be understood in that context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01767493 · results posted 27 August 2021
According to the results reported on ClinicalTrials.gov, this trial involved 19 participants, all of whom received a brain imaging scan using a radioactive tracer called [18F]Florbetapir (a substance that shows up on a special type of scan known as a PET scan). The trial was exploring whether this type of scan could detect areas of damage in the brain associated with relapsing-remitting multiple sclerosis (MS) — a form of MS where symptoms come and go. Of the 19 people who started the study, 16 completed it and 3 did not. The reported data shows that the primary thing being measured was the total number of damaged brain areas (called lesions) that the PET scan was able to detect across all participants. According to the results reported on ClinicalTrials.gov, the scan identified a total of 194 lesions across the group. The reported data also notes that the size of a lesion appeared to matter — lesions smaller than 5 millimetres were described as less easy to pick up on the scan. No other outcome figures were reported in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04032171 · results posted 5 August 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT04032171) was studying evobrutinib (combined with a dummy version of Avonex®) compared to Avonex® (combined with a dummy version of evobrutinib) in people with multiple sclerosis (MS). The trial was designed to run for 96 weeks and planned to measure things like how often relapses occurred, whether disability worsened over time, how participants felt physically and how fatigued they were, and the number of certain lesions visible on brain scans. According to the reported data, only one participant was enrolled in the evobrutinib group, and no participants were enrolled in the Avonex® comparison group — meaning the trial was effectively stopped before it could properly get underway. The reported data shows that because enrolment was so limited — just one person started and no one completed the trial — no results were recorded for any of the outcome measures. This includes the main measure (how often relapses occurred over 96 weeks), as well as all the secondary measures such as disability progression at 12 and 24 weeks, physical function scores, fatigue scores, and MRI scan findings. For every single measure, the data was not reported, rather than there being numbers to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02255656 · results posted 23 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02255656) enrolled 1,062 people who received the drug alemtuzumab, a treatment being studied for multiple sclerosis. Participants were split into two groups: those who received alemtuzumab from the start of the study (called the Initial Alemtuzumab Treatment, or IAT, group) and those who switched to alemtuzumab after starting on a different treatment (called the Delayed Alemtuzumab Treatment, or DAT, group). The trial tracked participants for up to around 5.6 years. Of the 1,062 who started, 592 completed the study and 470 did not. The reported data shows that the primary focus of this trial was on monitoring and recording adverse events — that is, any unwanted medical occurrences during the study period. Across all alemtuzumab participants, 879 out of 1,062 experienced at least one adverse event during the treatment period, and 237 experienced a serious adverse event (one serious enough to require hospitalisation, be life-threatening, or cause lasting disability, among other criteria). Reactions during or within 24 hours of the infusion (the drip used to give the drug) were recorded in 164 participants overall. Certain pre-specified events of special interest — such as autoimmune conditions, serious infections, and malignancy (cancer) — were recorded in 70 participants across the full group. Abnormal results on specific blood tests were also noted across varying numbers of participants in each category. The reported data shows that for the secondary outcomes, the average number of relapses per person per year was 0.20 in the DAT group and 0.16 in the IAT group. The proportion of participants who remained relapse-free over the course of the study was reported as approximately 29.6% in the DAT group and 36.9% in the IAT group. These are numbers describing what was observed and recorded during the study period only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02660138 · results posted 16 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02660138) involved 227 participants split into three groups: 76 people received a placebo (inactive treatment), 76 received a 600-unit dose of Dysport®, and 75 received an 800-unit dose of Dysport®. Dysport® is a botulinum toxin product injected into the bladder. The trial was measuring changes in urinary incontinence (UI) — that is, unplanned leakage of urine — as well as several bladder function measurements taken during a specialised bladder-filling test. It is worth noting that only a small number of participants were recorded as completing the full study (6 in the placebo group, 2 in the 600-unit group, and 3 in the 800-unit group), with the large majority recorded as not completing it. The reported data shows that the primary outcome — the average change in the weekly number of UI episodes after six weeks — was a reduction of 12.7 episodes per week in the placebo group, 23.5 in the 600-unit group, and 24.9 in the 800-unit group. These are averages calculated using a statistical modelling method, not simple averages. For the secondary outcomes, the reported data shows changes in bladder capacity (how much the bladder could hold): the placebo group saw a small decrease of 8.5 mL, while the 600-unit group increased by 152.4 mL and the 800-unit group by 180.7 mL. Pressure inside the bladder during filling (maximum detrusor pressure) was reported to decrease by 5.4 units in the placebo group, 29.8 units in the 600-unit group, and 34.1 units in the 800-unit group. The volume of fluid in the bladder at the point of the first involuntary bladder contraction increased by 14.0 mL in the placebo group, 169.4 mL in the 600-unit group, and 195.7 mL in the 800-unit group. When looking at individual participants, 3 people in the placebo group, 21 in the 600-unit group, and 21 in the 800-unit group were reported to have no UI episodes at week six. Additionally, 6 participants in the placebo group, 20 in the 600-unit group, and 42 in the 800-unit group were reported to have no involuntary bladder contractions detected during the bladder-filling test at week six. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02660359 · results posted 16 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02660359) enrolled 257 adults across three groups: 86 received a placebo (inactive treatment), 86 received Dysport® at a dose of 600 units, and 85 received Dysport® at a dose of 800 units. The trial was measuring changes in urinary incontinence (UI) — that is, unintentional leaking of urine — over a six-week period following treatment. Participants kept a bladder diary for seven days at a time to track how often leaking occurred. The reported data shows that, at six weeks, the average weekly number of leaking episodes fell by approximately 12.9 in the placebo group, 21.8 in the 600-unit group, and 22.6 in the 800-unit group. For the secondary measures, the reported data shows that complete resolution of leaking episodes (zero episodes recorded) was reported in about 1.3% of the placebo group, 36.6% of the 600-unit group, and 26.0% of the 800-unit group. Looking at those who saw their leaking episodes reduce by at least 50%, the reported figures were 38.2% (placebo), 72.0% (600-unit), and 61.6% (800-unit). The median time before participants sought re-treatment was reported as 132 days for the placebo group, 238.5 days for the 600-unit group, and 210 days for the 800-unit group. Changes in bladder capacity (how much the bladder could hold) were also measured; the placebo group showed an average increase of 3.5 mL, while the 600-unit and 800-unit groups showed average increases of 178.5 mL and 171.9 mL respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01006265 · results posted 11 June 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called ponesimod in people with multiple sclerosis (MS). A total of 464 participants were enrolled across four groups: some received ponesimod at one of three different daily doses (10 mg, 20 mg, or 40 mg), and others received a placebo (a dummy treatment with no active ingredient). The trial ran for 24 weeks and was mainly measuring the number of new brain lesions visible on MRI scans — a type of brain imaging — that "lit up" with a special dye (called gadolinium-enhancing lesions), as a way of tracking MS disease activity. The reported data shows that for the main measurement — the cumulative number of these new MRI lesions counted between weeks 12 and 24 — the placebo group had an average of 6.2 lesions, while the ponesimod groups had averages of 3.5 lesions (10 mg), 1.1 lesions (20 mg), and 1.4 lesions (40 mg). For one of the secondary measurements, the reported average number of confirmed MS relapses per year was 0.601 in the placebo group, compared with 0.297, 0.396, and 0.224 in the 10 mg, 20 mg, and 40 mg ponesimod groups respectively. A relapse here means a new or worsening MS symptom lasting at least 24 hours, confirmed by a neurological examination. The reported data also shows that, over the 24-week period, 25 out of 121 placebo participants experienced their first confirmed relapse, compared with 14 out of 108 in the 10 mg group, 17 out of 116 in the 20 mg group, and 10 out of 119 in the 40 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03126760 · results posted 3 June 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03126760) involved 35 people with multiple sclerosis (MS) — 18 received a treatment called Acthar Gel and 17 received a placebo (an inactive substitute). The trial was measuring scores on something called the Expanded Disability Status Scale, or EDSS — a 10-point scale used to assess neurological impairment in people with MS, where 0 means a normal neurological examination and 10 means death due to MS. Scores were recorded at the start of the trial (baseline) and again at Day 42. The person collecting these scores did not know which treatment each participant had received. The reported data shows that at the start of the trial, the average EDSS score was very similar between the two groups — 3.86 for the Acthar Gel group and 3.85 for the placebo group. By Day 42, the reported data shows the Acthar Gel group had an average score of 2.92, while the placebo group had an average score of 3.62. No other outcome measures were included in the structured data submitted to ClinicalTrials.gov, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT03364036 · results posted 27 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03364036) enrolled 270 participants, all of whom received the study treatment Mavenclad® (cladribine tablets). All 270 participants completed the study with none recorded as having dropped out. The trial was primarily measuring changes in brain and spinal cord lesions detected by MRI scans — specifically a type called "combined unique active" (CUA) lesions, which are areas of inflammation or new damage visible on the scans. The study also tracked changes in the levels of different immune cells (the cells the body uses to fight illness) in the blood over two years. The reported data shows that, compared to the period before treatment began, the average number of CUA lesions on MRI scans fell across three different measurement windows during the first six months. The reported changes were a reduction of approximately 1.2 lesions in the first window, 1.5 lesions in the second, and 1.5 lesions in the third. Regarding immune cells, the reported data shows notable percentage reductions from baseline in two types of immune cells — B cells and T cells (both involved in the body's immune response) — at various time points over two years, with reductions ranging roughly from around 25% to 80% depending on the cell type and time point measured. A third type of immune cell, NK cells (natural killer cells), showed smaller and more variable percentage changes, with some time points showing slight increases and others showing reductions of up to around 33%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03041025 · results posted 24 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03041025) enrolled 35 people in total across three groups: 8 received a placebo (a dummy treatment with no active ingredient), 3 received a lower dose of the investigational medicine GSK2330811 (100 mg), and 24 received a higher dose (300 mg). The trial was primarily measuring safety-related information — specifically, how many participants experienced medical events (called adverse events) while on the study, and whether certain blood test values changed during the trial period. The reported data shows that when it came to medical events, all 8 placebo participants and all 24 participants in the 300 mg group experienced at least one non-serious adverse event, as did all 3 in the 100 mg group. Serious adverse events — defined as medical occurrences that were life-threatening, required hospitalisation, caused lasting disability, or were otherwise judged significant by a doctor — were reported in 1 out of 8 placebo participants, 0 out of 3 in the 100 mg group, and 2 out of 24 in the 300 mg group (noting that two of these serious events were reported after participants had already finished the study). The reported data also shows changes from the starting point in a range of blood measurements (such as red and white blood cell counts, haemoglobin levels, and platelet counts) across the three groups. The numbers for most of these blood values showed small shifts up or down from the starting point in all three groups; the specific figures for each measurement at each time point were reported but the data submitted does not include the full set of time-point values for every measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00613171 · results posted 21 May 2021
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called STI571 (also known as imatinib) in people with systemic sclerosis, a condition that causes the skin and other tissues to harden and thicken. A total of 27 people started the trial, 13 completed it, and 14 did not finish. The trial was measuring two main things: changes in skin thickness over time using a scoring tool called the Modified Rodnan Skin Score (MRSS), and how many participants experienced unwanted medical events (called adverse events) during the study. The reported data shows that the average skin thickness score at the start of the trial was 25.7 out of a maximum possible 51 (where a higher number means more severe skin thickening). The scores reported at various points during the study fluctuated, with some time points showing scores slightly higher than the starting point and later time points showing a reported drop — the last recorded figure showed a change of around −12.61 points from baseline, meaning the average score appeared lower than at the start. Regarding unwanted medical events, the reported data shows that all 27 participants experienced at least one adverse event, and 5 participants experienced a serious adverse event. For the secondary outcome measuring how participants responded based on their skin scores at up to 48 weeks, the reported data shows that the majority of participants at each assessed time point fell into the "non-response" category (meaning less than a 25% reduction in their skin score), with small numbers recorded as having a partial response and very few or none recorded in the higher response categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01854359 · results posted 19 May 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people — 31 in the active treatment group and 30 in the placebo (dummy treatment) group. The trial was measuring disability levels in people with multiple sclerosis (MS) over time. The main thing being tracked was a combined disability score called CombiWISE, which pulls together four different tests of movement and function into a single number ranging from 0 (no disability) to 100 (maximum disability). Participants were followed across three phases: a lead-in period before any treatment, a two-year double-blind phase (where neither participants nor doctors knew who received what), and a one-year extension phase. By the end, 26 people in the active treatment group and 22 in the placebo group completed the trial. The reported data shows the following CombiWISE scores across the phases (expressed as a time-adjusted area under the curve — essentially a summary of how scores accumulated over each period): in the placebo group, the score went from 1.55 before treatment, to 0.80 during the double-blind phase, and 0.46 in the extension phase; in the active treatment group, it went from 0.89 before treatment, to 0.75 during the double-blind phase, and 1.30 in the extension phase. For the secondary measures, the reported data shows that the time taken to walk 25 feet increased slowly in both groups during the main trial (by about 0.04 seconds per year in the placebo group and 0.04 seconds per year in the active treatment group). The disability scores from the EDSS neurological scale also crept upward at similar rates in both groups (roughly 0.11–0.14 points per year). The fine motor (hand) test and the Scripps neurological scale showed similarly small changes across both groups. No data appears to have been reported on statistical comparisons between groups for these measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02907177 · results posted 18 May 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02907177) involved 136 people with multiple sclerosis (MS), split into two groups of 68. One group received a combination of two medicines — ponesimod and dimethyl fumarate (DMF) — while the other group received a dummy (placebo) treatment alongside DMF. The trial was measuring things like how often MS relapses (sudden worsening of symptoms) occurred, whether disability progressed over time, and what unwanted medical events (called adverse events) participants experienced. Notably, the data shows that zero participants in either group completed the study, and all 136 were recorded as "not completed," though the reasons for this were not detailed in the reported data. The reported data shows that the ponesimod-plus-DMF group had an average of 0.237 confirmed relapses per year, compared to 0.187 in the placebo-plus-DMF group. For disability worsening measured over 96 weeks (roughly two years), 18.7% of participants in the ponesimod-plus-DMF group showed a confirmed increase in disability scores, compared to 11.9% in the placebo-plus-DMF group. The reported data also shows that 33.6% of participants in the ponesimod-plus-DMF group experienced a confirmed relapse over 96 weeks, compared to 25.7% in the placebo-plus-DMF group. Regarding unwanted medical events, 48 out of 67 treated participants in the ponesimod-plus-DMF group and 53 out of 68 in the placebo-plus-DMF group were reported to have experienced at least one adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02830074 · results posted 22 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02830074) involved 63 people in total — 32 in a group called "The BEST Program" and 31 in a group receiving "Sleep Education and Standard Sleep-disordered Breathing Treatment." All participants completed the study with no drop-outs reported. The trial was looking at people who use a breathing device called PAP (positive airway pressure) — commonly known as CPAP — and was measuring things like how consistently they used that device, their sleep quality, mood, quality of life, lung function, and day-to-day functioning. The reported data shows that, for the main outcomes, the BEST Program group used their PAP device for an average of about 22 nights out of 90 where they wore it for 4 or more hours, compared to around 18.5 nights in the comparison group. On the Pittsburgh Sleep Quality Index — a questionnaire where lower scores mean better sleep quality (scale 0–21) — the BEST Program group scored an average of about 7.0, while the comparison group scored about 9.1. For depressive symptoms (scale 0–27, where lower is better), the reported averages were roughly 5.0 for the BEST Program group and 8.4 for the comparison group. On quality of life (measured across four areas, each scored 0–100 where higher is better), the BEST Program group scored between approximately 60 and 74 across the four areas, compared to roughly 55 to 70 for the comparison group. The reported data also shows results for lung function and day-to-day functioning, though these figures covered multiple sub-scores and the data was not always straightforward to separate out. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00678496 · results posted 17 March 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people with multiple sclerosis (MS) — 12 in each group. One group used a computerised cognitive behavioural therapy (CBT) program called "Beating the Blues," while the other received their usual care. The trial was measuring changes in self-reported depression symptoms and the impact of MS on daily life. Not everyone completed every stage: by the end of the study, 10 people in the computerised CBT group and 8 in the usual care group had fully completed the trial. The reported data shows that depression symptoms were tracked using a questionnaire called the BDI-II, where higher scores indicate more severe symptoms (the scale runs from 0 to 63). At 21 weeks from the start, the computerised CBT group reported an average reduction of 5.33 points, while the usual care group reported an average reduction of 1.17 points. A separate measurement at an earlier timepoint showed a reduction of 2.00 points in the CBT group, compared with a small increase of 0.25 points in the usual care group. For quality of life related to MS (measured on a 0–100 scale where higher scores mean greater impact on daily life), the reported data shows reductions across both groups at both the 8-week and 21-week points, with the computerised CBT group generally reporting somewhat larger reductions than the usual care group at each timepoint. It is worth noting that this was a very small trial, and the results as reported reflect averages across a small number of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02861014 · results posted 3 February 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 680 people with multiple sclerosis (MS) who were all given a medicine called ocrelizumab. There was no comparison group — everyone received the same treatment. The main thing the trial was set out to measure was how many participants showed "no evidence of disease activity" (sometimes called NEDA) over a roughly two-year period (96 weeks). Disease activity was defined as having at least one of the following: a relapse, worsening disability that lasted at least 24 weeks, or new or changed areas of damage visible on MRI brain scans. Of the 680 who started, 641 completed the primary analysis period. The reported data shows that 74.8% of participants had no evidence of disease activity over the full 96-week period, as defined by the trial's criteria. Looking at shorter time windows, 87.1% were free from a defined disease activity event at 24 weeks, and 82.6% at 48 weeks. For the measure tracking "time to first disease activity event," the data was not reported as a usable figure. The trial also tracked participants' disability scores using a standard MS scale (EDSS, which runs from 0 to 10). The reported data shows the average score at the start of the trial was 2.09 points. The reported changes from that starting score to 96 weeks were very small (ranging from –0.03 to +0.01 points across different sub-measurements). In terms of how individual participants' scores shifted, 72.2% were reported as staying in the same disability category, 13.4% moved to a lower (better) category, and 14.4% moved to a higher (worse) category. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00835770 · results posted 31 December 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT00835770) enrolled 868 people in each of two groups — one taking BG00012 (also known as dimethyl fumarate) twice a day (BID) and one taking it three times a day (TID) — giving a total of 1,736 participants. This was a long-term follow-on study for people with multiple sclerosis (MS), and it tracked untoward medical events (called adverse events), MS relapses, disability scores, and brain scan findings over a number of years. Notably, around 44% of participants in each group completed the study, with the remainder not finishing for various reasons (which were not broken down further in the data provided here). The reported data shows that the primary thing measured — the number of people who experienced at least one adverse event (any unwanted medical occurrence during the study) — was 824 out of 868 in the twice-daily group and 814 out of 868 in the three-times-daily group. For relapses (defined as new or returning neurological symptoms lasting at least 24 hours), the reported percentage of participants who had at least one relapse ranged from 31% to 41% across the different subgroups, depending on what treatment they had received before entering this study. The rate of relapses per year across those subgroups ranged from approximately 0.16 to 0.21. On the disability scale (which runs from 0, meaning no disability, to 10, meaning death), the reported average scores at the final measurement point ranged from about 2.43 to 2.68 across subgroups, with changes from the starting point ranging from approximately 0.26 to 0.53 of a scale point. Brain scan measurements of inflammation-related lesions (bright spots seen on MRI scans using a special dye) showed average counts of between 0.1 and 0.6 lesions across the different subgroups at the time points reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02201108 · results posted 30 November 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 166 participants across two main groups during the double-blind phase: 57 received a placebo and 109 received teriflunomide (a medicine being studied). The trial was designed to look at how long it took for participants to experience their first confirmed neurological relapse (a new or returning episode of neurological symptoms lasting at least 24 hours), and also tracked brain scan changes over time. The study ran in several phases, with the double-blind period lasting up to about two years (96 weeks), followed by an open-label period and a longer extension phase. The reported data shows that, during the double-blind period, the average time to a first confirmed relapse was reported as approximately 39 weeks in the placebo group and approximately 75 weeks in the teriflunomide group. For the secondary measures, the reported data shows that the estimated proportion of participants who remained relapse-free was higher in the teriflunomide group at most time points measured — for example, at around the two-year mark (Week 96), approximately 60 in every 100 teriflunomide participants were reported as relapse-free, compared with approximately 44 in every 100 in the placebo group. Brain scan results reported that participants in the teriflunomide group had an average of about 5.7 new or enlarged lesions (areas of change in the brain) per scan, compared with about 11.1 in the placebo group. Similarly, another type of brain lesion measured per scan averaged about 1.5 in the teriflunomide group versus about 2.7 in the placebo group. Changes in the total volume (size) of brain lesions were also measured at multiple time points, with the reported figures generally showing smaller increases in the teriflunomide group, though the differences varied across the different time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02936037 · results posted 23 November 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02936037) looked at a treatment called MD1003 in people with progressive multiple sclerosis. A total of 316 people were assigned to a placebo (a dummy treatment with no active ingredient) and 326 were assigned to MD1003, making 642 participants in the main double-blind phase — meaning neither the participants nor the researchers knew who was receiving which treatment. The trial was primarily measuring whether participants showed an improvement in either their disability score (a standard scale used to assess MS-related disability, called the EDSS) or their walking speed over a 25-foot course, with those improvements confirmed at set timepoints. After the main phase, 528 participants continued into an open-label extension, where everyone received MD1003. The reported data shows that for the main outcome — the proportion of people who showed a confirmed improvement in their disability score or walking speed — 9.2% of those in the placebo group and 12.0% of those in the MD1003 group met this measure. For the secondary outcomes (such as time to disability worsening, participants' and doctors' global impressions of change, and changes in walking speed), no numerical results were included in the data submitted to ClinicalTrials.gov, so those figures cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01526356 · results posted 26 October 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 179 people across three groups: 59 received a 1% rapamycin cream, 63 received a 0.1% rapamycin cream, and 57 received a placebo (an inactive cream). Of those, 51, 53, and 45 people respectively completed the study. The trial was measuring changes in the appearance of facial angiofibromas — small skin growths on the face that are associated with a condition called tuberous sclerosis — using a scoring system called the Angiofibroma Grading Scale (AGS), as well as quality-of-life questionnaires completed by participants, children, and their families. The reported data shows that, on the primary measure (the AGS score, which runs from 0 to 202 with higher numbers meaning more severe appearance), the average score change from the start of the trial was −13.89 points in the 1% rapamycin group, −12.71 points in the 0.1% rapamycin group, and −1.39 points in the placebo group — meaning all groups had lower scores at the end, with the rapamycin groups showing larger reductions. For a secondary measure where independent photo reviewers rated whether each participant's skin looked "better, same, or worse" compared to their starting photos, 45 participants in the 1% group and 38 in the 0.1% group were rated as "better," compared with 13 in the placebo group; 5, 11, and 15 were rated "same"; and 5, 9, and 23 were rated "worse." Quality-of-life score changes (on scales of 0–30, where lower means less impact) were small across all groups, and the data for skin sensitivity events at the application site was also reported, with 6, 5, and 2 events in the placebo group across three categories, compared with generally lower numbers in the rapamycin groups — though the trial was not specifically designed to measure this. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02792218 · results posted 19 October 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02792218) enrolled 927 people with multiple sclerosis — 465 received a treatment called OMB 20 mg and 462 received a comparison treatment called TER 14 mg. The main thing the trial was measuring was the **annualised relapse rate (ARR)** — that is, the average number of confirmed MS relapses per person per year across each group. Several secondary measurements were also recorded, including how many participants experienced their disability level worsening or improving over time, as measured by a standard MS disability scale (EDSS). The reported data shows that the ARR was 0.11 in the OMB group and 0.22 in the TER group — meaning, on average, the OMB group had roughly 0.11 relapses per person per year and the TER group had roughly 0.22. For the secondary measures looking at disability worsening confirmed over three months, the reported data shows figures of around 9–11% of participants in the OMB group and around 14–15% in the TER group experienced worsening (results were reported both for this study alone and combined with a related study). For disability worsening confirmed over six months, the reported figures were around 7–8% in the OMB group and around 11–13% in the TER group. The reported data also shows that around 10–11% of the OMB group and around 8% of the TER group showed a confirmed improvement in disability scores sustained over six months. It is worth noting that the trial was not specifically designed with enough participants to draw firm conclusions from the disability worsening and improvement measures on their own, and those results were intended to be combined with a separate related study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02792231 · results posted 19 October 2020
According to the results reported on ClinicalTrials.gov, this trial compared two treatments for multiple sclerosis (MS): ofatumumab (OMB) at 20 mg and teriflunomide (TER) at 14 mg. A total of 481 people were assigned to the OMB group and 474 to the TER group, making 955 participants overall. Of those, 399 and 390 respectively completed the study. The trial's main goal was to measure how often participants experienced MS relapses (sudden worsening of symptoms) over the course of a year. It also tracked changes in participants' disability levels over time, using a standard MS disability rating scale (EDSS — a numbered scale that measures how much MS affects a person's movement and daily functioning). The reported data shows that the average number of confirmed relapses per year (called the annualised relapse rate) was 0.10 in the OMB group and 0.25 in the TER group. For the secondary measurements, the reported data shows that when looking at disability worsening confirmed over at least three months (drawing on combined data from this and a related trial), 9.4% of the OMB group and 13.5% of the TER group showed worsening — with a second analysis from this study alone showing 9.3% versus 13.2%. For worsening confirmed over at least six months, the combined data showed 7.8% (OMB) versus 10.7% (TER), while this study alone showed 8.0% versus 10.0%. The reported data also shows that when measuring disability *improvement* sustained for at least six months (combined data), 10.1% of the OMB group and 7.6% of the TER group showed an improvement, with this study alone reporting 11.0% versus 8.2%. It is worth noting that the disability worsening and improvement measurements were not originally designed to be assessed in this trial alone — the trial was intentionally combined with a second related study to have enough participants to draw meaningful conclusions from those figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02544763 · results posted 23 September 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02544763) looked at a cannabis-derived medicine called GWP42003-P (also known as cannabidiol) in people with tuberous sclerosis complex (TSC), a genetic condition that can cause seizures. A total of 224 participants took part — 75 received the lower dose (25 mg/kg/day), 73 received the higher dose (50 mg/kg/day), and 76 received a placebo (a dummy treatment with no active ingredient). The trial's main goal was to measure how much the number of TSC-related seizures changed from the start of the trial to the end of the treatment period. The reported data shows that, for the main outcome, participants in the lower-dose group had an average reduction in TSC-associated seizures of about 43%, those in the higher-dose group had a reduction of about 37%, and those in the placebo group had a reduction of about 20% — all compared to their own seizure counts at the start of the trial. For one of the secondary outcomes, the number of participants whose seizures fell by 50% or more was reported as 27 in the lower-dose group, 29 in the higher-dose group, and 17 in the placebo group. When looking at all seizure types combined, the reported reductions were approximately 35% for both dose groups and about 20% for the placebo group. Caregivers and participants also rated overall condition on a 7-point scale (where 1 means "very much improved" and 7 means "very much worse"); the reported average scores were around 3.0–3.1 for the lower-dose group, 3.1–3.2 for the higher-dose group, and 3.5 for the placebo group. Regarding severe unwanted events that occurred during treatment, the reported data shows 7 participants in the lower-dose group, 9 in the higher-dose group, and 1 in the placebo group experienced a severe treatment-emergent adverse event (an unwanted health event that happened after starting the study medicine). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02258217 · results posted 1 September 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02258217) enrolled 30 people with multiple sclerosis (MS), and all 30 completed the study — no one dropped out. The trial had a single group, meaning everyone received the same treatment with no comparison group. The study was measuring how participants responded to treatment for an MS relapse (a flare-up of symptoms), using two patient-reported questionnaires: the ARMS survey (which looks at how a relapse affects daily life and how a person feels after treatment) and the MSIS-29 (which asks people to rate how much MS has affected their physical and psychological wellbeing over the previous two weeks). The reported data shows the following ARMS questionnaire scores. For day-to-day activities (ADL, scored 0–9 where higher is better functioning), the score before treatment was 3.1 and after treatment was 4.9. For return to previous health (RSH, scored −1 to 10 where higher means a more complete return), the score before treatment was 4.6 and after treatment was 4.4. A combined score called the Partial Composite Score (PCS, scored 0–20) was 7.7 before treatment and 9.2 after. A Total Composite Score (TCS, scored 0–30, measured after treatment only) was reported as 14.3. For the MSIS-29 questionnaire — where higher scores mean a greater negative impact — the physical score (range 20–100) was 58.5 before treatment and 56.0 after, and the psychological score (range 9–45) was 29.4 before treatment and 26.3 after treatment. These numbers represent what was recorded and reported for this group of 30 participants. Because there was no separate comparison group in this trial, the reported figures reflect only the scores within this single group at two points in time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01982942 · results posted 28 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT01982942) enrolled 255 people with multiple sclerosis — 129 received a medicine called ibudilast and 126 received a placebo (a dummy capsule with no active ingredient). The trial ran for 96 weeks (about two years). Its main goals were to measure changes in brain size over time using a specialised brain scan, and to record how many participants experienced unwanted side effects. Several additional measurements were also taken, including brain scans that look at water movement in nerve fibres, myelin content (the protective coating around nerve fibres), and the thickness of a layer of the retina (the light-sensitive tissue at the back of the eye). The reported data shows that, for the primary brain-size measurement, both groups showed a small decline in brain tissue over the study period. The ibudilast group had a rate of change of −0.00168 (a unit called brain parenchymal fraction, which is simply the proportion of the skull's interior taken up by brain tissue), while the placebo group had a rate of change of −0.00392. Regarding unwanted events, 92.2% of participants in the ibudilast group and 88.1% in the placebo group were reported to have experienced at least one adverse event (an undesirable experience during the study). For the secondary scans measuring water movement in nerve fibres, myelin content, and retinal thickness, the reported numbers were small differences between the two groups; for example, the magnetisation transfer ratio (a myelin-content measure) was reported as 0.325 for the ibudilast group and 0.247 for the placebo group, and average retinal nerve fibre layer thickness was 83.0 micrometres for the ibudilast group versus 79.5 micrometres for the placebo group. The reported data also shows that the number of new brain lesions (areas of damage visible on scans) seen since the start of the study was 0.355 for the ibudilast group and 0.317 for the placebo group. These figures are averages across each group. It is important to note that this summary only describes the numbers as submitted to the clinical trial registry; it does not interpret whether any differences between groups are meaningful or not. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03257358 · results posted 21 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03257358) enrolled a total of 382 participants across two groups — 165 people in Cohort 1 and 217 people in Cohort 2. The trial was measuring changes in specific types of immune cells (white blood cells that play a role in the body's immune system) in the blood over six months. Several subtypes of these cells — known as CD4+ T cells — were tracked, including "naive," "central memory," "effector memory," and other specialised varieties. Blood samples of roughly 60–80 ml were collected at set points during the study and analysed by a central laboratory. The reported data shows the starting levels (baseline) of these immune cell types and how they changed after six months, measured in cells per microlitre of blood. For Cohort 1, the starting counts were notably higher across all cell types measured — for example, naive CD4+ T cells started at around 404 cells/µL and were recorded at about 7.6 cells/µL at Month 6, representing a reported change of approximately −411 cells/µL. Similar downward trends were reported for the other cell subtypes in Cohort 1. For Cohort 2, starting levels were much lower across all cell types — for instance, naive CD4+ T cells began at around 3.4 cells/µL and showed a reported change of approximately +0.8 cells/µL at six months, meaning counts in Cohort 2 remained comparatively stable throughout the period measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT04355663 · results posted 17 July 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT04355663) enrolled 92 people in total across three groups, each receiving a different type of physical therapy for multiple sclerosis: Motor Program Activating Therapy (42 people), Vojta's Reflex Locomotion (29 people), and Functional Electric Stimulation (21 people). Not everyone finished the trial — 40, 14, and 17 people completed it in each group respectively. The trial was measuring brain white matter structure using a brain scan technique, as well as balance, walking ability, and how much MS was affecting participants' daily lives and walking, as rated by the participants themselves. The reported data shows that for the primary measure — a brain scan score called fractional anisotropy (FA), which reflects certain properties of nerve fibres in the brain on a scale from 0 to 1 — the Motor Program Activating Therapy group scored 0.50, the Vojta's Reflex Locomotion group scored 0.52, and the Functional Electric Stimulation group scored 0.47. For the secondary measures, the reported data shows balance scores (where higher is better, out of 56) were 49.8, 47.9, and 32.8 for the three groups respectively. On the walking time test (where a shorter time is better), the groups recorded average times of 10.2 seconds, 10.3 seconds, and 16.9 seconds. On the self-rated walking limitation scale (0–100, where higher means more limitation), scores were 61.6, 59.8, and 73.9. On the self-rated MS impact scale (0–100, where higher means greater impact on daily life), scores were 32.9, 33.4, and 43.5. It is important to note that the reported data shows only the scores recorded at the end of the study for each group — starting scores and any comparisons between groups were not included in the submitted results data, so it is not possible from these numbers alone to draw conclusions about changes over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03093324 · results posted 14 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 254 people in the ALKS 8700 group and 252 people in the Dimethyl Fumarate (DMF) group — 506 participants in total. The trial was comparing these two treatments (both used for multiple sclerosis) by tracking how often participants experienced stomach and gut symptoms such as nausea, vomiting, upper and lower abdominal pain, and diarrhoea. Participants rated these symptoms daily using a diary app, on a scale from 0 (no symptom) to 10 (extreme). The main thing being measured was the proportion of days on which any one of those symptoms reached a score of 2 or more out of 10. The reported data shows that, for the primary measure, participants in the ALKS 8700 group recorded gut symptom scores of 2 or above on approximately 1.5% of their days on treatment, compared with approximately 2.5% of days for the DMF group. For the secondary measures, when a lower threshold of 1 or above was used, the reported figures were 2.9% of days for ALKS 8700 and 3.9% for DMF. When a higher threshold of 3 or above was used, the figures were 0.9% and 1.5% respectively. A separate overall gut symptom score (rating all symptoms together as a single impression) showed figures of 2.1% versus 2.8% of days at a threshold of 1 or above, and 1.1% versus 1.5% of days at a threshold of 2 or above. In a subset of the study period examined separately, the reported figures for the main measure were 1.3% of days for ALKS 8700 and 2.2% for DMF. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03060759 · results posted 13 May 2020
According to the results reported on ClinicalTrials.gov, this trial looked at two different types of light therapy and their relationship to fatigue levels in people with multiple sclerosis. A total of 35 people took part — 20 in the first light therapy group (Spectrum 1) and 15 in the second group (Spectrum 2). By the end of the study, 15 people had completed the first group and 12 had completed the second group, meaning 8 people across both groups did not finish the trial. The reported data shows that the trial measured fatigue using something called the Fatigue Severity Scale (FSS). This is a questionnaire that produces a score between 9 and 63, where a lower number means a person reported feeling less fatigued. The results reported for the primary outcome show average FSS scores at the end of the study — the first light therapy group (Spectrum 1) had an average score of 45.8, and the second group (Spectrum 2) had an average score of 46.7. It is worth noting that the outcome measure is described as "change" in fatigue scores, but starting (baseline) scores were not included in the data submitted, so it is not possible to describe how much scores may have shifted from the beginning of the trial. No secondary outcome measures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02987621 · results posted 5 February 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT02987621) involved 14 people in total, split into two groups of 7. It used a "crossover" design, meaning everyone received both the real treatment and a sham (dummy) version at different times, with a 7-day break in between. The trial was looking at whether a form of mild electrical brain stimulation called tDCS (transcranial direct current stimulation) had any effect on leg muscle strength and endurance in participants. All 14 people who started the trial completed it, with no drop-outs reported. The reported data shows that when leg muscle strength was measured (using a force test of the knee muscles, recorded in Newtons), the figures reported were 323 Newtons and 330 Newtons across the two conditions — though the data as submitted does not clearly separate which figure belongs to the real tDCS condition and which to the sham condition. For muscle endurance — measured as how long participants could hold a leg muscle contraction before stopping, recorded in seconds — the two reported figures were 1,087 seconds and 872 seconds. Again, the submitted data does not clearly label which result corresponds to tDCS and which to sham. For the third primary measure, a 6-Minute Walk Test (how far participants could walk in 6 minutes), no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01337986 · results posted 30 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people with multiple sclerosis across two groups of 23 each. It used a crossover design, meaning each group took the study drug (dalfampridine, a tablet sometimes used in MS) for one period and a placebo (a dummy pill) for another period. The trial was measuring whether dalfampridine had any effect on visual function — specifically how well participants could see low-contrast images, which is a common challenge for people with MS. By the end of the trial, 20 people in one group and 18 in the other had completed the study. The reported data shows that the main measure of vision used was something called a LogMAR contrast sensitivity score — essentially a standardised way of counting how many letters on a low-contrast eye chart a person can read (a lower score generally means better performance on this type of chart). When participants were taking dalfampridine, the reported average score improvement from their starting point ranged from 0.04 to 0.06 LogMAR units depending on the analysis used; when taking placebo, the reported improvement ranged from 0.05 to 0.08 units. In terms of actual letters read, both the dalfampridine and placebo periods were associated with participants reading 2–4 more letters than at their starting visit. A separate brain-signal measurement (called visual evoked potential, which tracks how quickly the brain responds to a visual signal) showed an average response time of 121.6 milliseconds on dalfampridine and 120.2 milliseconds on placebo. For the secondary measures, the reported data shows that about 9.7% of eyes improved by two lines (10 letters) on the contrast chart while on dalfampridine, compared with 11.1% on placebo; 11.1% also improved during both treatment periods and 68.1% improved during neither. For a smaller improvement of one line (5 letters), 11.1% of eyes showed this on dalfampridine, 15.3% on placebo, 37.5% during both periods, and 36.1% during neither period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02019927 · results posted 18 January 2020
According to the results reported on ClinicalTrials.gov, this trial looked at whether a device that delivers small electrical pulses through a contact lens placed on the eye (called transcorneal electrical stimulation) could change vision in people with one of three eye conditions: a condition called non-arteritic ischaemic optic neuropathy (NAION, where blood supply to the optic nerve is reduced), optic nerve damage related to multiple sclerosis, or eye injury (ocular trauma). For each condition, some participants received the active device and others received a "sham" version — meaning the device was applied but not actually switched on — so the two groups could be compared. In total, 97 people started the trial across all six groups, and 84 completed it. The reported data shows that the main thing being measured was change in visual sharpness (how clearly a person can read letters on a chart) from the start of the trial to week 8, using a standard scale called logMAR — on this scale, a lower (more negative) number means letters were read more clearly. The NAION active group showed a reported average change of −0.23, compared with −0.14 in the NAION sham group. The multiple sclerosis active group showed a reported change of −0.08, compared with −0.06 in the sham group. The ocular trauma active group showed a reported change of −0.29, compared with −0.05 in the sham group. The trial pre-defined a change of −0.2 or more as a meaningful improvement. The reported data also includes several secondary measurements — eye pressure, visual field (the width of what a person can see), and the thickness of nerve fibre layers at the back of the eye — with small numerical changes recorded across all groups; these varied in direction and size between active and sham groups, and the full details are available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02234713 · results posted 18 January 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 63 young people with multiple sclerosis — 31 in a behavioural intervention group (which included feedback on their medication-taking) and 32 in a video attention control group (who watched videos instead). The trial was measuring how well participants stuck to their disease-modifying medication (called "adherence") over six months, using both electronic bottle/injection caps that recorded each time medication was accessed, as well as questionnaires filled in by patients and their parents. By the end of the study, 25 people in the behavioural group and 27 in the control group had completed the trial. The reported data shows the following numbers across the two groups at three time points — baseline (the start), three months, and six months. For the electronic cap measure (where 1.0 would mean taking every single dose), the behavioural group started at 0.95, then was recorded at 0.81 at three months and 0.81 at six months; the video control group started at 0.86, then 0.82 at three months and 0.66 at six months. On the Morisky questionnaire (scored 0–8, where 8 means the highest adherence), the behavioural group scored around 6.28 at the start and 5.93 at six months, while the control group scored around 6.40 at the start and 5.94 at six months. For the MSTAQ questionnaire (a separate adherence and barriers tool scored 0–100), scores across both groups hovered closely around the 49–50 range at all time points, with little apparent difference reported between groups. Parental involvement — meaning how often parents reminded, supervised, or administered medication — was also tracked as a percentage, with the behavioural group going from about 45% at baseline to 36% at six months, and the control group from about 38% to 30%. Quality of life scores (PedsQL, 0–100 with higher being better) were also reported as a secondary measure, with both groups scoring in the low-to-mid 70s to low 80s across the study period; the data was not reported in a way that breaks this figure down further by subgroup at every time point. The Well-Being outcome was listed but no measurements were reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02555215 · results posted 22 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02555215) enrolled 20 people, all of whom received a medicine called dimethyl fumarate. Seventeen of the 20 participants completed the study, while three did not finish. The trial was measuring how many participants experienced unwanted medical events (called adverse events) and serious adverse events, as well as tracking brain scan changes and any relapses (episodes of worsening neurological symptoms) over time. The reported data shows that 18 out of 20 participants experienced at least one adverse event during the study, and 2 participants experienced a serious adverse event — meaning a medical event considered potentially life-threatening, requiring hospitalisation, or otherwise significant. No participants stopped taking the study medicine because of an adverse event. For the brain scan results, the data shows the number of new or growing lesions (areas of change visible on MRI scans) detected at two different time points, though the way the numbers were reported across multiple categories makes a straightforward summary difficult; the reported figures ranged from 0 to 12 participants depending on the lesion count category and time point. Regarding relapses, the reported data shows that 10% of participants experienced one or more relapses during the study, and the average relapse rate across the group was reported as 0.1 relapses per person-year (meaning, on average, roughly one relapse per ten years of follow-up across all participants combined). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01201356 · results posted 7 November 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 4,125 people with relapsing forms of multiple sclerosis (MS), all of whom took fingolimod 0.5 mg once a day. Of those who started, 4,083 were included in the safety analysis and 3,481 completed the study. The trial was measuring two main things: first, how often participants experienced unwanted health events (called adverse events), serious adverse events, or deaths; and second, how often participants experienced MS relapses (a return or worsening of MS symptoms) and changes seen on brain scans over time. The reported data shows that, out of the 4,083 participants in the safety group, 2,125 experienced at least one adverse event (an unwanted health occurrence of any kind), 515 experienced a serious adverse event, and 16 deaths were recorded. Regarding MS relapses, the reported data shows an "annualised relapse rate" — that is, an estimate of how many relapses per person per year — starting at 0.325 in the first period and gradually falling to 0.170 by the end of follow-up. The number of participants who had experienced at least one relapse grew over time as the study continued, reaching 3,072 by the final time point, which reflects the longer time participants had to potentially experience a relapse. Brain scan results (measuring areas of MS activity called T2 lesions) also showed changing numbers across the study period, but no comparative or control group data was reported for these figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02038049 · results posted 30 October 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02038049) looked at a treatment called VAY736 compared to a placebo (an inactive dummy treatment) in people with relapsing-remitting multiple sclerosis (MS — a condition where the immune system attacks the brain and spinal cord). A total of 8 people took part — 4 received VAY736 and 4 received the placebo. Three people in the VAY736 group and all 4 in the placebo group completed the study. The trial used brain MRI scans (detailed imaging) at several points over 16 weeks to count specific types of lesions — areas of damage visible on the scans — as a way of tracking MS activity in the brain. The reported data shows the following lesion counts from the MRI scans. For the primary measure — new lesions seen on a type of scan called T1-weighted with a special dye (gadolinium) at weeks 8, 12 and 16 combined — the VAY736 group had counts of 5, 5, and 6 lesions respectively, while the placebo group had 1, 2, and 3. For all T1-weighted lesions (not just new ones) across weeks 4, 8, 12 and 16, the VAY736 group showed totals of 19, 20, 20, and 21, compared to 2, 2, 3, and 4 in the placebo group. A separate measure counted the total volume of a different type of lesion (T2-weighted); the VAY736 group's figures ranged from around 18,103 to 20,109 cubic millimetres across the time points, while the placebo group's ranged from around 15,996 to 17,919 cubic millimetres. The trial notes that only descriptive statistics were performed — meaning no formal statistical comparison between the two groups was carried out, likely because the number of participants was very small. The reported data also shows how many participants showed no new MRI activity at each time point: at week 4, this was 4 out of 4 in the VAY736 group and 2 out of 4 in the placebo group; at week 8, it was 1 and 0; at week 12, it was 0 and 1; and at week 16, it was 3 and 3. It is important to note that with only 4 people in each group, these numbers are far too small to draw any broad conclusions, and the trial itself did not attempt a formal statistical comparison. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02373098 · results posted 30 September 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02373098) enrolled 66 people with relapsing-remitting multiple sclerosis (RRMS) who were treated with a medicine called fingolimod (also known as FTY720), and 60 healthy volunteers for comparison. Of the RRMS group, 54 people completed the study, while 12 did not finish; all 60 healthy volunteers completed their part. The trial was measuring levels of certain proteins in the blood — called cytokines and chemokines — which are substances the immune system produces. Researchers looked at these levels before treatment started and at several follow-up visits, using two different laboratory methods: a test called ELISA (which measures protein levels in the liquid part of blood) and a method called flow cytometry (which counts and analyses individual blood cells). The reported data shows that at the start of the study, before any treatment, people with RRMS and healthy volunteers had somewhat different protein levels in their blood. For example, one protein measured by ELISA showed a level of about 404 pg/ml (picograms per millilitre, a very small unit of measurement) in the RRMS group, compared with about 212 pg/ml in healthy volunteers. Another protein read about 67 pg/ml in the RRMS group versus less than 1 pg/ml in healthy volunteers. When the blood cell counts were examined, one cell type showed roughly 1,611 cells in the RRMS group compared with about 2,048 in healthy volunteers. The reported data also shows changes in some of these protein levels across three study visits in the RRMS group during treatment — for instance, one protein measured at about 67 pg/ml at Visit 1, dropping to around 50 pg/ml at Visit 2, then rising to approximately 150 pg/ml at Visit 3. Some measurements across visits were not broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02606604 · results posted 30 September 2019
According to the results reported on ClinicalTrials.gov, this trial involved 15 people with Multiple Sclerosis — 8 in a group that used Functional Electrical Stimulation (FES) Cycling (where gentle electrical pulses help the muscles pedal a stationary bike) and 7 in a group that did regular cycling only. Fourteen of the 15 participants finished the study; one person in the FES Cycling group did not complete it. The trial was measuring walking speed and self-reported fatigue at different points in time. The reported data shows that walking speed — measured by timing how long it took participants to walk 25 feet — was recorded at multiple time points for both groups. For the FES Cycling group, the reported speeds across the four measurement points were 1.33, 1.34, 1.39, and 1.44 metres per second. For the Cycling Only group, the reported speeds were 1.40, 1.42, 1.45, and 1.42 metres per second. On the fatigue questionnaire (scored from 0 to 81, where higher numbers mean fatigue was felt to have a bigger impact on daily life), the reported data shows the FES Cycling group scored 42 at one time point and 32 at another, while the Cycling Only group scored 47.13 and 39.57 at those same time points. It is worth noting that this was a small study with fewer than 20 participants, so the numbers above reflect a very limited group of people. No additional breakdown of the data (such as averages with ranges or comparisons between groups) was included in what was submitted to ClinicalTrials.gov, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02881567 · results posted 24 September 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 41 participants, all of whom received a treatment called daclizumab. The trial was looking at how many people with relapsing multiple sclerosis (MS) went without a relapse — defined as new or returning neurological symptoms lasting at least 24 hours, with no fever or infection to explain them — over a period of up to 12 months. Of the 41 people who started the trial, 23 completed it and 18 did not. The reported data shows that for the main outcome being tracked, approximately 66.6% of participants were estimated to be relapse-free at the six-month mark, based on a statistical method (called a Kaplan-Meier estimate) that accounts for participants who left the study at different points in time. For two secondary outcomes related to brain scan findings — using a type of MRI scan to look for new areas of activity or change in the brain — the reported data shows that 3 participants had new gadolinium-enhanced or T1 lesions, and 3 participants had new or newly enlarged T2 lesions, both measured across the six- and twelve-month period combined. The reported data shows that several other planned secondary outcomes — including the percentage of participants relapse-free at 12 months, the rate of relapses requiring hospitalisation or steroid treatment, and the overall annual relapse rate at 12 months — were not reported in the data submitted to ClinicalTrials.gov, so no figures are available for those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02315872 · results posted 13 August 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 8 people in total — 4 in the ACTH (a hormone medication) group and 4 in the placebo (dummy treatment) group. The trial was measuring self-reported fatigue, depression, daytime sleepiness, and quality of life in participants at 28 weeks, using standard questionnaires. Of the 8 who started, only 4 finished the trial — 1 person in the ACTH group and 3 in the placebo group completed it, meaning the numbers involved are very small. The reported data shows the following scores at 28 weeks. For fatigue, the ACTH group recorded scores of 56.5 (on one fatigue scale) and 55.0 (on a second fatigue scale), while the placebo group recorded 29.0 and 40.0 respectively — on both scales, higher numbers indicate greater fatigue impact. For depression, the ACTH group scored 16.5 and the placebo group scored 40.0, where a higher number indicates greater depression severity. For daytime sleepiness, the ACTH group scored 11.0 and the placebo group scored 7.0, with higher scores meaning more daytime sleepiness. For quality of life (measured across two components), the ACTH group scored 39.5 and 37.5, compared to 49.0 and 45.0 for the placebo group — here, higher scores indicate less difficulty with daily life. It is important to note that because so few people participated and only one person in the ACTH group completed the trial, the reported numbers reflect an extremely small sample. The reported data shows scores across the two groups, but no further statistical analysis data was included in what was submitted to ClinicalTrials.gov, so broader conclusions cannot be drawn from these figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00203021 · results posted 18 July 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT00203021) involved 208 people with Multiple Sclerosis — 107 in a "delayed start" group and 101 in an "early start" group, referring to when they began receiving glatiramer acetate (a medication used in MS). The trial tracked participants over a very long period — up to 288 months (24 years). The two main things being measured were: how many participants experienced any unwanted medical events (called adverse events), and how disability levels changed over time using a standard MS disability scale called the EDSS, which runs from 0 (normal) to 10 (death due to MS). The reported data shows that when it came to adverse events (any unwanted medical occurrence), 107 out of 107 participants in the delayed-start group and 100 out of 101 in the early-start group experienced at least one adverse event of any kind. Serious adverse events were reported in 44 participants in the delayed-start group and 38 in the early-start group. Regarding disability scores, the reported data shows that at the 288-month (24-year) point, the average change in EDSS score from the start of the study was 1.64 points in the delayed-start group and 1.06 points in the early-start group — meaning both groups showed some increase in their disability score over that time. It is worth noting that only 28 and 24 participants respectively completed the full study period, so results at that final timepoint are based on a much smaller number of people than started. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02939079 · results posted 14 May 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02939079) enrolled 50 people with multiple sclerosis, split evenly into two groups of 25. One group took the medication fingolimod together with fish oil supplements, and the other took fingolimod together with a placebo (a dummy supplement with no active ingredient). The trial was measuring levels of certain proteins in the blood — known as inflammatory markers — that the immune system produces. These included TNF-α, IL-1β, IL-6, and IFN-gamma (all chemical messengers involved in the body's immune response). By the end of the trial, 21 people in the fish oil group and 20 in the placebo group had completed the study. The reported data shows the following blood protein levels (measured in picograms per millilitre, a very small unit of concentration) at the end of the study period. For TNF-α, three separate measurements were recorded across what appear to be different time points: the fish oil group returned figures of 37.16, 28.03, and 21.20, while the placebo group returned 28.79, 17.18, and 16.47. For IL-1β, the fish oil group recorded 13.76 and the placebo group recorded 14.00. For IL-6, the fish oil group recorded 6.19 and the placebo group recorded 6.33. For IFN-gamma, the fish oil group recorded 6.38 and the placebo group recorded 6.98. No further context about the timing of the individual TNF-α measurements was provided in the submitted data, and no additional detail about statistical analysis was reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00745615 · results posted 27 March 2019
According to the results reported on ClinicalTrials.gov, this trial involved people with multiple sclerosis (MS) and tested a medicine called laquinimod at two different daily doses — 0.3 mg and 0.6 mg. The trial had two main stages: a double-blind extension phase lasting 36 weeks (where neither participants nor doctors knew who was receiving which treatment), followed by a longer open-label phase lasting up to approximately 10.5 years (where everyone knew which treatment was being taken). In the double-blind phase, 257 participants were enrolled across four groups. In the open-label phase, 209 participants continued across two groups. The primary outcomes were focused on tracking adverse events (that is, any unwanted medical occurrences during the study) and how many people stopped the study early and why. The reported data shows that during the double-blind phase, the number of participants who experienced at least one adverse event ranged from 23 to 66 people depending on the group. During the open-label phase, 86 out of 96 participants in one group and 100 out of 113 in the other group reported at least one adverse event. Regarding early drop-outs during the double-blind phase, between 1 and 7 participants per group left the study for any reason, with between 1 and 3 per group leaving specifically due to adverse events. In the open-label phase, the large majority of participants did not complete the full period — 91 out of 96 and 108 out of 113 did not finish — though only 1 and 9 participants respectively left due to adverse events. For the secondary outcomes, the reported relapse rates across all double-blind groups were similar, ranging from approximately 0.36 to 0.39 relapses per year, and the percentage of participants who had no relapses during the double-blind period ranged from about 64% to 73% across the four groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00950248 · results posted 7 March 2019
According to the results reported on ClinicalTrials.gov, this trial involved people with a neurological condition and was conducted in two main stages. In the first year, 85 people were observed without any treatment (77 completed this phase). After that, 77 of those participants were randomly assigned to receive either idebenone (39 people) or a placebo — a dummy treatment with no active ingredient (38 people) — for a further two years. The trial's main goal was to track changes in an overall disability score called CombiWISE, which combines several standard tests of walking, hand function, and general neurological ability into a single number ranging from 0 (no disability) to 100 (maximum disability). The reported data shows that for the primary outcome — changes in the CombiWISE disability score over the two-year treatment period — the idebenone group recorded an average change of −0.13 units per year, while the placebo group recorded −1.04 units per year. For the secondary outcomes, the reported data shows that brain ventricle volume (fluid-filled spaces in the brain, where enlargement can signal tissue loss) changed by −244 ml per year in the idebenone group compared with +35.4 ml per year in the placebo group. The median time until a measurable worsening of disability (as measured by a combined score called EDSS-plus) was reported as 23.1 months in the idebenone group and 23.7 months in the placebo group. Changes in walking speed, hand function, and a separate neurological exam score were also measured; the reported figures for all of these were small in both groups, and the full details are available in the trial record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02575365 · results posted 27 February 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02575365) enrolled 4 participants, all of whom were placed in a single group receiving fingolimod, a medication used in multiple sclerosis (MS). The trial was designed to look at changes in cognitive (thinking and memory) abilities over time in people with MS, using a set of established tests, and to also examine brain changes on MRI scans and certain markers measurable in the blood. The study was planned to run for up to 24 months. The reported data shows that none of the 4 participants completed the trial — all 4 withdrew or did not finish for reasons not detailed in the submitted data. Because no participants completed the study, no results were recorded for any of the outcome measures. This includes the primary outcome — a battery of cognitive tests called the BICAMS, which covers memory, attention, and information-processing speed — as well as the secondary outcomes, which included additional thinking tests (the PASAT and Stroop tests), MRI measurements of brain tissue changes, and blood-level measurements of several biological substances. The reported data shows no numerical results for any of these measures, as the data was not reported. It is worth noting that a trial with only 4 participants enrolled and none completing is considered very small and incomplete, meaning no conclusions about the treatment can be drawn from these results. The reported data shows only that the study did not reach its intended completion. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01498887 · results posted 25 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 347 people in total — 200 who had not previously been treated for their condition (described as "naïve or de novo" participants) and 147 who had already been on a first-line disease-modifying therapy. The trial was measuring how often relapses (episodes of new or worsening neurological symptoms) occurred over 12 months in people taking 0.5 mg of fingolimod, as well as a number of secondary measures including disability scores, brain volume changes on MRI, and the proportion of participants who remained relapse-free. The reported data shows that the average number of relapses per year — known as the annual relapse rate — was 0.29 for the previously untreated group and 0.35 for the previously treated group. Around 71.9% of previously untreated participants and 66.7% of previously treated participants had no relapses during the 12-month period. For the disability scale (which runs from 0, meaning a normal neurological examination, to 10), the reported change from the start of the trial was 0.00 for the untreated group and −0.077 for the previously treated group, where a negative number indicates a small improvement. Brain volume, measured by MRI, showed a reported percentage change of −0.595% in the untreated group and −0.387% in the previously treated group, where a negative figure indicates a reduction in brain volume. For the time-to-first-relapse measure, the data was not reported in the submitted results. Regarding relapse severity among those who did relapse, the reported data shows that in the untreated group approximately 42.6% of relapses were mild and 57.5% were moderate-to-severe; in the previously treated group, approximately 38.5% were mild, 56.4% were moderate-to-severe, and 5.1% were classified as severe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02949908 · results posted 18 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT02949908) enrolled only 2 participants, both of whom were being treated with Rebif (interferon beta-1a) for relapsing-remitting multiple sclerosis (RRMS) — a form of MS where symptoms flare up and then partially or fully ease. Neither participant completed the study; both withdrew before it finished. The trial was primarily measuring how satisfied participants were with their medication, using a standard questionnaire called the TSQM v II, where people rate their satisfaction on a scale of 1 (extremely dissatisfied) to 7 (extremely satisfied). It also tracked things like how often relapses occurred, whether participants stuck to their treatment schedule, and quality of life. The reported data shows that on the main satisfaction measure, the average score recorded was 5 out of 7, which on that scale corresponds to "Satisfied." A second version of the same primary satisfaction measure had no data reported. For the secondary outcomes, the reported data shows that 1 out of 2 participants was recorded as adhering to (following) their treatment as prescribed. The quality-of-life questionnaire (MusiQoL) returned an average score of 4 out of 6, and 1 participant was recorded as having stopped their initial MS treatment. The annualised relapse rate — a measure of how many relapses occurred per year on average — was not reported in the submitted data. It is important to note that because only 2 people participated and neither completed the trial, the numbers above are based on an extremely small group and should be interpreted with great caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01047319 · results posted 9 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01047319) enrolled 1,047 participants across three groups: 345 people who had been taking laquinimod from the start of the earlier study ("Early Laquinimod"), 350 people who had previously been on a placebo and then switched to laquinimod ("Switch From Placebo"), and 352 people who had previously been on a different medication called Avonex and then switched to laquinimod ("Switch From Avonex"). The trial was primarily measuring how many participants experienced unwanted medical events — called adverse events — after starting or continuing treatment. It also tracked things like blood pressure and heart rate readings, blood test results, and heart tracing (ECG) results. The reported data shows that, for the primary measure of unwanted medical events, 290 out of 345 participants in the Early Laquinimod group, 303 out of 350 in the Switch From Placebo group, and 279 out of 352 in the Switch From Avonex group recorded at least one such event during the study. Serious events — meaning those involving hospitalisation, life-threatening situations, significant disability, or other major medical concerns — were recorded in 20, 28, and 23 participants respectively across the three groups. For the secondary measures, relatively small numbers of participants showed notable changes in vital signs such as blood pressure or pulse. Similarly, small numbers showed significant shifts in blood chemistry or blood count results. For heart tracings (ECGs), shifts from a normal reading at the start to a clinically significant abnormal reading at any point during the study were recorded in 5, 7, and 20 participants across the three groups — though the data was not reported in a way that explains the reasons for those shifts. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00988052 · results posted 8 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 839 participants in total — 423 in the "Early Laquinimod" group (who received the study drug throughout) and 416 in the "Switch From Placebo" group (who started on a dummy treatment before switching to laquinimod). The trial was primarily focused on tracking unwanted medical events (called adverse events) that occurred during treatment, as well as monitoring things like blood pressure, heart rate, blood test results, and heart tracings (ECGs). The reported data shows that in the primary outcome — tracking any unwanted medical events during treatment — 375 out of 423 participants in the Early Laquinimod group and 374 out of 416 in the Switch group experienced at least one such event. Serious medical events (those involving hospitalisation, life-threatening situations, or significant disability) were recorded in 108 participants in the Early Laquinimod group and 92 in the Switch group. For the secondary outcomes, notable changes in vital signs (such as blood pressure or pulse reaching certain thresholds) were seen in 36 Early Laquinimod participants and 34 Switch participants. Potentially significant changes in blood chemistry tests were recorded for small numbers of participants across both groups, and changes in blood count tests were seen in 36 and 29 participants respectively. For heart tracings (ECGs), shifts from a normal reading to a clinically significant abnormal reading were reported in 2 Early Laquinimod participants and 3 Switch participants. It is worth noting that the data shows zero participants recorded as having "completed" the study in the formal milestone tracking, though the reason for this is not explained in the submitted data. The reported figures above reflect what was submitted to ClinicalTrials.gov, but no explanation for missing completion data was provided, so that detail cannot be clarified here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02044510 · results posted 7 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 32 people in total — 16 received a medicine called mirabegron and 16 received a placebo (a dummy treatment with no active ingredient). The trial was looking at bladder function in people with neurogenic bladder, a condition where nerve damage affects bladder control. The main thing the researchers measured was bladder capacity (how much urine the bladder could hold), tested using a procedure called urodynamics. The trial also planned to measure a number of other things, including bladder diary results, urine leakage amounts, and quality of life, though results for those measures were not reported in the data submitted to ClinicalTrials.gov. The reported data shows that, at the end of the study, the average bladder capacity in the mirabegron group was 305 millilitres, while in the placebo group it was 369 millilitres. These are the only numbers provided in the submitted results. As noted above, the secondary outcome measures — which included voiding diary recordings, pad weight tests (measuring urine leakage over 24 hours), and three separate quality-of-life questionnaires — did not have any numerical results reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02743312 · results posted 6 November 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 5 people in total — 3 in the group that tried torso weights first followed by sham (dummy) weights, and 2 in the group that tried sham weights first followed by torso weights. All 5 participants completed the study. The trial was looking at whether wearing torso weights (small weights worn on the body) had any measurable impact on things like daily step counts, balance, walking speed, and how people with multiple sclerosis (MS) felt about their movement and confidence. It used a "crossover" design, meaning each person tried both the real weights and the sham weights at different times, allowing a comparison within the same individuals. The reported data shows the following changes measured during each condition. For the balance test (scored 0–100, where higher means better balance), the torso weights group showed a reported change of +7.4 points compared to +1.0 point for the sham weights group. For walking speed, the torso weights group showed a reported change of +0.125 metres per second, while the sham weights group showed –0.03 metres per second. For self-reported movement ability (scored 0–6), both groups showed small reported changes: +0.36 for torso weights and +0.30 for sham weights. For self-reported balance confidence (scored 0–100), the reported changes were +1.5 for torso weights and +3.0 for sham weights. For the MS impact scale (where lower numbers mean less impact from MS), the reported changes were –6.7 (torso weights) and –5.25 (sham weights) on the physical side, and –4.4 (torso weights) and –6.1 (sham weights) on the psychological side. The primary outcome — daily step counts — was listed in the trial but no numerical results were reported in the data submitted to ClinicalTrials.gov. It is worth noting that with only 5 participants, this was a very small study, and the reported numbers describe what was observed in this specific group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01067521 · results posted 9 October 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01067521) involved people with relapsing multiple sclerosis and looked at a medicine called glatiramer acetate (GA) given as a 40 mg injection three times a week. A total of 1,404 participants took part in the first (placebo-controlled) phase — 943 in the "Early Start" group, who received the active medicine straight away, and 461 in the "Delayed Start" group, who received a dummy (placebo) injection for the first year before switching to the active medicine. The trial measured how often participants had relapses (periods when MS symptoms temporarily worsen), as well as changes visible on brain scans. The reported data shows that during the placebo-controlled period, the Early Start group had an adjusted average of 0.331 confirmed relapses compared to 0.505 in the Delayed Start (placebo) group. When expressed as relapses per year across the whole study, the reported figures were 0.26 for the Early Start group and 0.31 for the Delayed Start group. For brain scan findings, the Early Start group had an adjusted average of 3.65 new or enlarged T2 lesions (areas of concern visible on MRI) combined across months 6 and 12, compared to 5.59 in the Delayed Start group. For a different type of MRI lesion (gadolinium-enhancing lesions, which can indicate active inflammation), the adjusted averages were 0.91 for the Early Start group and 1.64 for the Delayed Start group. Brain volume change over 12 months was reported as −0.71% for the Early Start group and −0.65% for the Delayed Start group. Over the longer term (covering months 6, 12, and 36 combined), the reported data shows the Early Start group continued to have lower average numbers of new or enlarged T2 lesions on brain scans compared to the Delayed Start group at each time point, with figures of 2.87 versus 3.90 at month 6, 4.48 versus 7.09 at month 12, and 5.84 versus 8.76 at month 36. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01892722 · results posted 19 September 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01892722) compared two treatments for multiple sclerosis — fingolimod and interferon beta-1a — in a group of 215 participants (107 in the fingolimod group and 108 in the interferon beta-1a group). The trial ran for up to 24 months and was primarily measuring how often participants experienced relapses (episodes where MS symptoms flare up or worsen) during that time. By the end of the study, 100 participants in the fingolimod group and 88 in the interferon beta-1a group had completed the full trial period. The reported data shows that the main outcome was measured using something called the annualised relapse rate — simply put, the average number of confirmed relapses per person per year. The fingolimod group had a reported rate of 0.122 confirmed relapses per year, while the interferon beta-1a group had a reported rate of 0.675 confirmed relapses per year. These are the numbers as submitted by the trial sponsor. For the secondary outcomes — which included things like changes on MRI brain scans, time to a first relapse, the proportion of people who had no relapses, and how the body processed the fingolimod medication — no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02499900 · results posted 20 August 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02499900) involved 861 people with multiple sclerosis — 430 in one group and 431 in another. Both groups took a medicine called Copaxone (glatiramer acetate), but on different schedules: one group took a 20 mg dose every day, and the other took a 40 mg dose three times a week. The main thing the trial was measuring was how satisfied participants were with their medication over six months, using a simple 1-to-7 rating scale (where 1 means extremely dissatisfied and 7 means extremely satisfied). The trial also looked at a range of other things, including how convenient participants found their treatment, how fatigue affected their daily life, mental health, and symptoms of depression. The reported data shows that at the six-month mark, the average satisfaction score was 5.4 out of 7 for the daily-dose group and 5.7 out of 7 for the three-times-a-week group. For convenience (scored 0–100, where 100 is most convenient), the reported scores were 69.7 for the daily group and 79.2 for the three-times-a-week group. On the fatigue scale (where a negative change means less impact from fatigue), both groups showed small reductions from their starting scores, with the daily group reporting a change of around −2.8 and the three-times-a-week group around −3.6 out of a possible range of 0–84. Mental health scores and depression scores also shifted slightly in both groups, with the reported numbers showing small changes from baseline in each direction depending on the subscale measured. The reported data also notes how many participants experienced adverse events — that is, any health changes recorded during the study. In the main study period, 219 out of 427 participants in the daily-dose group and 231 out of 430 in the three-times-a-week group had at least one recorded adverse event. Serious adverse events (defined as those leading to hospitalisation, significant disability, or other major outcomes) were reported for 8 participants in the daily group and 13 in the three-times-a-week group during the core period, with lower numbers in the extension period. No deaths were reported in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02410278 · results posted 24 July 2018
According to the results reported on ClinicalTrials.gov, this trial involved 102 people who first went through a run-in period where they all took a medicine called dimethyl fumarate (DMF). Of those, 64 completed this first stage. Those who developed stomach and gut symptoms during that time were then randomly placed into one of two groups for the main part of the trial: 31 people received a placebo (a dummy treatment with no active ingredient) and 33 received a medicine called montelukast. The trial was measuring gut-related symptoms — things like stomach pain, nausea, and discomfort — using a questionnaire called the GSRS, which scores symptoms from 0 (no symptoms) to 6 (the worst possible). The goal was to see whether montelukast could reduce the gut symptoms that some people experience when taking DMF. The reported data shows that for the main question the trial was designed to answer — how many participants saw their gut symptoms get worse over the first 10 days — 17% of people in the placebo group and 33% of people in the montelukast group recorded a worsening in their scores. For the secondary measures, the reported data shows that both groups started with a baseline GSRS score of around 0.80 to 0.84. Over the following days and weeks, both groups recorded reductions in their scores (meaning fewer reported symptoms), with the placebo group showing a change of around −0.28 to −0.37 and the montelukast group showing a change of around −0.21 to −0.31 across the various time points measured. The reported data also shows that the median time to a first worsening of symptoms was 10 days in the placebo group and 7 days in the montelukast group, and that both groups had a median recovery time of 1 day back to their starting score after their worst point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02545868 · results posted 6 June 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT02545868) enrolled 102 people across three groups — Group A1 (33 people), Group A2 (35 people), and Group B (34 people). The trial was measuring how the immune systems of participants in these groups responded to a tetanus vaccine, as well as to a separate test substance called KLH (keyhole limpet haemocyanin), which researchers use as a tool to assess how well the immune system produces antibodies — proteins the body makes in response to a foreign substance. Very few participants completed the study in the traditional sense: only 2 in Group A1, 1 in Group A2, and none in Group B, with the large majority recorded as "not completed," though the data does not explain the reasons in detail. The reported data shows that for the primary outcome — the percentage of participants who showed a meaningful rise in tetanus antibody levels eight weeks after vaccination — 23.9% of the combined Group A participants met this threshold, compared with 54.5% of Group B participants. A similar pattern was reported at four weeks: 24.2% in Group A and 60.6% in Group B. When a slightly different measure was used (either reaching a certain antibody level or doubling their antibody level), the reported figures were 40.9% for Group A and 87.9% for Group B. The reported data also shows mean (average) antibody levels for tetanus and the KLH test substance across different time points, with Group B generally showing higher average antibody levels than Group A at later measurement points, though the data does not label which time points each set of numbers corresponds to. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01896700 · results posted 5 April 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01896700) enrolled 24 people in total — 12 in a group that received methylphenidate (a medication sometimes known by brand names like Ritalin) and 12 in a group that received a placebo (an inactive dummy treatment). The trial ran for 6 weeks and was measuring changes in balance, walking speed, sleep quality, fatigue, and a reflex that helps keep vision steady during head movement. Of those who started, 8 people in the methylphenidate group and 6 in the placebo group completed the study. The reported data shows the following changes from the start of the trial to 6 weeks. For the main measure — a timed test of standing up, walking a short distance, and sitting back down (called the Timed Up and Go test) — the methylphenidate group's average time changed by −0.7 seconds (slightly faster) and the placebo group's by −1.3 seconds (also slightly faster). For a 25-foot walking speed test, the methylphenidate group changed by −0.3 seconds and the placebo group by −0.6 seconds. On a fatigue questionnaire (scored 0–84, where higher means more fatigue), the methylphenidate group's average score changed by −3.8 points and the placebo group's by −9.8 points. On a sleep quality questionnaire (scored 0–21, where higher means poorer sleep), the methylphenidate group changed by +0.3 points and the placebo group by −0.3 points. For a balance reflex measure (automatic postural response latency), the methylphenidate group changed by −9.2 milliseconds and the placebo group by −5.3 milliseconds. Several additional measurements of a different balance reflex (vestibular-ocular reflex gain, which tracks how well the eyes compensate for head movement) were also recorded across different test conditions, with a range of small positive and negative changes in both groups, as reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01834586 · results posted 13 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 participants, all of whom received a topical anaesthetic patch called Synera (a combination of two numbing medicines applied to the skin). Twenty-nine of the 30 participants completed the trial, with one person not finishing. The trial was measuring pain levels — specifically, how much pain participants felt at the injection site, both at the moment of injection and over the following 24 hours. Pain was rated on a scale from 0 to 10, where 0 means no pain at all and 10 means the worst pain imaginable. The reported data shows that, right after the injection, participants rated their pain at an average of 5.7 out of 10 on that scale. For the secondary outcome — average injection-site pain tracked over the 24 hours following the injection — three separate measurements were reported, coming in at 2.24, 1.23, and 1.39 out of 10. The trial record does not provide further detail explaining what each of those three 24-hour figures individually represents (for example, whether they reflect different time points), so that context was not reported in the data available. It is worth noting that this trial had only one group, meaning there was no comparison group (such as a placebo or a different treatment) included in the results as submitted. The reported figures describe only what was measured in the Synera group alone, and no comparison numbers are available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01194570 · results posted 26 December 2017
According to the results reported on ClinicalTrials.gov, this trial looked at a drug called ocrelizumab (600 mg) compared to a placebo (an inactive treatment) in people with primary progressive multiple sclerosis. A total of 732 people took part — 244 in the placebo group and 488 in the ocrelizumab group. The trial was mainly measuring how long it took for participants to experience a confirmed worsening of their disability, as measured by a standard MS disability scale (where 0 means no disability and 10 means death from MS), with that worsening needing to last at least 12 weeks. The reported data shows that for the two main time-to-disability-worsening measures — one confirmed at 12 weeks and one at 24 weeks — the results were listed as "NA" (not available), meaning specific time figures were not reported in the submitted data. For the secondary outcomes where numbers were provided: the reported data shows that walking speed (measured by a timed 25-foot walk test) worsened on average by about 55% from the start in the placebo group, compared to about 39% in the ocrelizumab group. The volume of lesions visible on brain scans (areas of damage) increased by about 7.4% in the placebo group, while it decreased by about 3.4% in the ocrelizumab group. Overall brain volume change (measured from week 24 to week 120) was reported as a decrease of about 1.09% in the placebo group and about 0.90% in the ocrelizumab group. The reported data also shows that a self-reported quality-of-life score focused on physical health (on a 0–100 scale where higher means less disability) changed by about −1.1 points in the placebo group and about −0.7 points in the ocrelizumab group from the start of the trial to week 120. It is worth noting that a large proportion of participants in both groups did not complete the study — 155 out of 244 in the placebo group and 270 out of 488 in the ocrelizumab group — though the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02040116 · results posted 20 September 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants, all of whom completed the study. The trial was looking at what happened when people received rituximab (a type of infusion treatment given through a drip) in two different ways: a standard-speed infusion on the first visit, and then a faster "rapid" infusion — given over 90 minutes — on a second visit roughly two weeks later. The main things being measured were whether any reactions occurred during the drip, and how severe those reactions were. A secondary measurement looked at how much time participants spent in the day hospital. The reported data shows that zero infusion reactions were recorded for both the standard infusion and the rapid infusion. Regarding the severity (grade) of any reactions, the data for that outcome measure was not reported in the results submitted to ClinicalTrials.gov, so no numbers are available to describe here. For the secondary outcome, the reported data shows that the time spent in the day hospital changed by minus 10 hours — meaning participants spent 10 fewer hours in the day hospital at the rapid infusion visit compared to the standard infusion visit. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01247324 · results posted 18 July 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 821 adults with relapsing multiple sclerosis — 411 received interferon beta-1a (given by injection under the skin, 44 micrograms) and 410 received ocrelizumab. The trial ran for 96 weeks and was primarily measuring how often participants experienced MS relapses over that time. It also looked at several other things, including changes in disability levels and the number of new lesions (areas of damage) visible on brain scans. The reported data shows that, for the main outcome, the interferon beta-1a group had an average of 0.292 relapses per person per year of treatment, while the ocrelizumab group had an average of 0.156 relapses per person per year. For the brain scan results, the total number of a type of active lesion called "T1 gadolinium-enhancing lesions" (spots on the brain that light up on a special scan, suggesting recent activity) was 337 in the interferon group and 21 in the ocrelizumab group across the whole treatment period. The total count of new or growing T2 lesions (another type of scan marker) was 1,916 in the interferon group and 430 in the ocrelizumab group. Regarding disability improvement, 12.42% of eligible participants in the interferon group and 20.00% in the ocrelizumab group showed a confirmed improvement in their disability score over at least 12 weeks. The reported data for the two disability progression time-based outcomes shows "NA" (not available) for both groups, meaning those specific figures were not reported in this dataset. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00731692 · results posted 14 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 970 people with multiple sclerosis (MS) across three groups over a core study period of 36 months. One group (336 people) took a 0.5 mg daily dose of a drug called FTY720 (fingolimod) throughout the study, another group (487 people) started on a placebo (a dummy treatment with no active ingredient) and later switched to 0.5 mg FTY720, and a third, smaller group (147 people) started on a higher 1.25 mg dose before switching to 0.5 mg. The trial was measuring disability progression in people with primary progressive MS — that is, whether their MS-related physical difficulties worsened over time — using a combination of three tests: a standard disability rating scale (scored 0–10, where higher means more disability), a timed walking test, and a hand and arm function test. The reported data shows that, for the main (primary) outcome — the combined risk of disability worsening sustained over at least three months — 77.2% of participants in the FTY720 0.5 mg group and 80.3% of participants in the placebo group reached that threshold by the end of the study. For the disability rating scale alone, the figures were 54.3% and 58.7% respectively. For the hand and arm test, the reported numbers were nearly identical: 25.0% (FTY720) and 24.9% (placebo). For the walking test, the figures were 54.8% (FTY720) and 56.7% (placebo). On brain volume change, both groups showed a similar small reduction of around 1.49%–1.53% from their starting point. One secondary measure — the average number of new or growing brain lesions visible on MRI scans per year — was reported as 0.13 for the FTY720 group and 0.50 for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02342704 · results posted 9 June 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02342704) enrolled 108 people with multiple sclerosis — 54 in a group receiving natalizumab and 54 in a group receiving fingolimod. The trial was designed to compare these two treatments by looking at changes in brain lesions over time, measured using MRI scans. Very few participants completed the full study: only 1 person in the natalizumab group and 3 in the fingolimod group were recorded as completing it, with the large majority not completing the trial for reasons not detailed in the submitted data. The reported data shows that for the primary outcome — tracking a specific type of long-lasting brain lesion (called T1-hypointense lesions) that developed from active lesions seen on MRI scans — no numerical results were submitted to ClinicalTrials.gov, so those figures are not available. For the secondary outcomes, the reported data shows that the average cumulative number of new active brain lesions visible on MRI (called T1-Gd+ lesions, meaning lesions that "light up" with a special dye) was reported as 0.62 for the natalizumab group compared with 1.69 for the fingolimod group at one time point, with similar patterns at later time points. The average number of new or enlarging lesions on a different type of MRI scan (T2 lesions) was reported as 1.33 for natalizumab and 1.94 for fingolimod. Changes in total lesion volume from the start of the study were also reported across both scan types and time points, with figures varying between the two groups. The proportion of participants showing "no evidence of disease activity" — a combined measure of no relapses, no worsening disability, and no new lesions — was not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00930553 · results posted 15 May 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT00930553) enrolled 1,314 people with multiple sclerosis (MS) who had previously taken part in one of three earlier studies. All participants received the drug alemtuzumab during this extension phase. The trial was measuring how often participants experienced MS relapses (sudden worsening of symptoms) over time, and whether their level of disability — scored on a standard scale — changed. Of the 1,314 who started, 1,091 completed the study and 223 did not. The reported data shows that for participants who had been on alemtuzumab throughout, the average number of relapses per person per year (called the annualised relapse rate) ranged from approximately 0.12 to 0.24 across different follow-up periods and participant groups. For people who had previously been on a different MS medicine (interferon beta-1a) and then switched to alemtuzumab, the reported relapse rate before switching was 0.42 and 0.60 (depending on which earlier study they came from), and after switching it was reported as 0.14 and 0.15 respectively. For people who received an additional course of alemtuzumab, the reported relapse rate before that extra course was 0.79, and afterwards ranged from 0.18 to 0.30 across different measurement windows. On the disability scale (which runs from 0 to 10, with higher numbers meaning greater disability), the reported data shows that 79 and 118 participants (from the two main groups) experienced a confirmed worsening in disability that lasted at least six months. The reported data also shows that 74 and 130 participants (from the same two groups respectively) experienced a sustained improvement of at least one point on the disability scale lasting six months or more. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00676715 · results posted 11 May 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 218 people across four groups. Each group received a different combination of treatments over several phases: one group started on a placebo before switching to ocrelizumab 600 mg, one received ocrelizumab 600 mg throughout, one started on a higher dose of ocrelizumab (1000 mg) before moving to 600 mg, and one started on Avonex (a separate multiple sclerosis medicine) before switching to ocrelizumab 600 mg. The trial used brain scans (MRI) to count certain types of lesions — areas of inflammation in the brain — as its main way of measuring what was happening in participants over time. The reported data shows that for the primary measure — the average number of active (gadolinium-enhancing) brain lesions seen on MRI scans at weeks 12, 16, 20, and 24 — the placebo group had an average of 5.6 lesions, the ocrelizumab 600 mg group had 0.6, the ocrelizumab 1000 mg group had 0.2, and the Avonex group had 6.9. For the secondary measures, the reported annualised relapse rate (the estimated number of relapses per year) was 0.557 for the placebo group, 0.127 for ocrelizumab 600 mg, 0.213 for ocrelizumab 1000 mg, and 0.364 for the Avonex group. The reported data shows that the percentage of participants who had no relapses by week 24 was 75.9% in the placebo group, 85.5% in the ocrelizumab 600 mg group, 87.3% in the ocrelizumab 1000 mg group, and 77.8% in the Avonex group. Changes in the total volume of a different type of brain lesion (T2 lesions) from the start to week 24 were also reported, with the placebo group showing a reduction of about 112 cubic millimetres, the ocrelizumab 600 mg group a reduction of about 879 cubic millimetres, the ocrelizumab 1000 mg group a reduction of about 601 cubic millimetres, and the Avonex group an increase of about 1,040 cubic millimetres. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02133664 · results posted 3 May 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02133664) enrolled 54 people in total — 26 in the group taking a combination of lipoic acid and omega-3 fatty acids, and 28 in the placebo (dummy treatment) group. By the end of the 12-week study, 21 people in each group had completed it. The trial was measuring changes in four thinking and memory tasks commonly used in multiple sclerosis research: a number-adding attention test (PASAT), a colour-word test (Stroop), a word memory test (CVLT-II), and a word-generation test (COWAT). The reported data shows the following changes from the start of the study to 12 weeks. On the number-adding attention test, the lipoic acid and omega-3 group answered an average of 2.24 more questions correctly, while the placebo group answered 3.38 more correctly. On the colour-word test, both groups took less time to complete the task — the supplement group's time dropped by an average of 5.59 seconds and the placebo group's by 2.87 seconds. On the word memory test, both groups recalled a similar number of additional words on average (1.57 for the supplement group and 1.65 for the placebo group). On the word-generation test, the supplement group produced an average of 0.70 more words and the placebo group 0.39 more words. It is worth noting that these figures simply describe the average changes recorded in each group over the study period; no further breakdown or additional detail was included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00288626 · results posted 4 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people, all of whom received a treatment called high-dose immunosuppressive therapy followed by a stem cell transplant using their own cells (referred to as HDIT and HCT). The trial was measuring what happened to participants over five years after the transplant, specifically looking at "event-free survival" — meaning how many people went through that period without losing neurological function, having a relapse (a new or worsening episode of symptoms), or developing two or more new brain lesions on an MRI scan. Of the 24 who started, 17 completed the study and 7 did not. The reported data shows that the estimated probability of being "event-free" at three years after the transplant was approximately 0.784, and at five years it was approximately 0.692. In plain terms, these figures — calculated using a standard statistical method called Kaplan-Meier estimation — suggest that roughly 78 out of every 100 participants (in a group like this one) would be expected to remain free of those defined events at three years, and roughly 69 out of 100 at five years, based on what was observed. For overall survival (simply being alive), the reported probability remained at 1.0 (meaning all participants were alive) through the first two years, then was reported as approximately 0.957 at three years, 0.911 at four years, and 0.863 at five years. No deaths were recorded as being related to the treatment itself across all five years. The reported data also shows that 100% of participants experienced at least one serious adverse event (graded 3 or higher on a standard medical scale, meaning significant but not necessarily life-threatening). The reported data shows that no deaths were recorded as being directly related to multiple sclerosis disease progression in the first four years, with a probability of approximately 0.906 at the five-year mark. It is worth noting that this was a small trial with only 24 participants, and figures from small studies can shift considerably with just a few additional cases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01455220 · results posted 31 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01455220) enrolled 45 people with multiple sclerosis (MS). The study looked at whether natalizumab — a medication used to treat MS — was associated with any changes in sexual function and overall quality of life over six months. These things were measured using a series of questionnaires completed by participants at the start of the study and again at six months. Of the 45 people who started, 15 completed the study, and 30 did not complete it. The reported data shows the following changes in questionnaire scores from the start of the study to the six-month mark. For sexual dysfunction (measured by the MSISQ-19 questionnaire, where a higher score means more dysfunction), the reported average change was −0.697 — meaning scores shifted very slightly in the direction of less dysfunction on a scale that runs from 19 to 95. For a separate sexual function measure (part of the MSQOL-54 questionnaire, where a higher score means better function on a scale of 0 to 100), the reported average change was +0.29. For overall quality of life (also from the MSQOL-54), the reported average change was +0.73. For health-related quality of life measured by the FAMS questionnaire (which runs from 0 to 176, with higher scores indicating better function), the reported average change was +2.57. It is worth noting that only 15 of the 45 participants completed the study, which the data does not explain further. The reported changes in scores across all measures were small. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01333501 · results posted 21 March 2017
According to the results reported on ClinicalTrials.gov, this trial compared two treatments for what appears to be a neurological condition — fingolimod and interferon beta-1b — with a focus on measuring changes in thinking and memory abilities. A total of 106 people were assigned to the fingolimod group and 51 to the interferon beta-1b group at the start. Not everyone completed the trial: 97 people in the fingolimod group and 30 in the interferon beta-1b group finished. The trial used a standard set of thinking and memory tests (called the Brief Repeatable Battery) to measure things like verbal memory, visual-spatial memory, attention, and information processing speed. The reported data shows the changes in test scores from the beginning of the trial to the end, where a higher number means a better result on all tests. For verbal memory (how well people stored and recalled words), the fingolimod group showed average score changes of 6.32 and 5.93, compared to 4.46 and 3.96 for the interferon beta-1b group. For visual-spatial memory (reproducing patterns on a checkerboard), the fingolimod group showed a change of 1.46 compared to 3.06 for the interferon beta-1b group. For information processing speed (matching symbols to numbers quickly), the reported changes were 2.19 for fingolimod and 3.93 for interferon beta-1b. For working memory and attention tests (adding numbers heard out loud), the changes were 7.14 versus 6.68 (at the slower pace) and 4.79 versus 4.42 (at the faster pace). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01462318 · results posted 14 March 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01462318) looked at a medicine called DAC HYP and involved three groups of participants. The main study enrolled 113 people, of whom 105 completed it. A smaller sub-study focused on how DAC HYP might interact with other common medicines enrolled 20 participants, and all 20 completed it. A separate extension phase, which allowed participants to continue receiving the treatment for longer, started with 115 people and 70 completed it. The trial was primarily measuring whether the body developed immune responses to DAC HYP (in the form of binding antibodies and neutralising antibodies), and also examined how DAC HYP behaved in the bloodstream and whether it affected the way the body processed other medicines. The reported data shows that, when looking at binding antibodies (a type of immune response the body can produce against a medicine) across the main study, the numbers of participants who tested positive at various time points ranged from 21 to 92 out of those assessed. For neutralising antibodies (a stronger type of immune response that can block a medicine's action), the reported numbers of participants who tested positive at different time points ranged from 4 to 8, while between 104 and 109 participants did not show this type of response at those same points. In the smaller sub-study measuring how DAC HYP might affect other medicines processed by the body, the reported drug-exposure figures (a measure of how much of each test medicine was present in the blood over time) were broadly similar before and after DAC HYP was given, though the data was not reported with a full breakdown that would allow a simple before-and-after comparison in plain numbers. The reported data also shows that, in a group of 26 participants who had their blood tested more intensively, the peak level of DAC HYP in the bloodstream was reported as approximately 12.63 micrograms per millilitre at one dose and 29.07 at another, with the time to reach that peak being around 9 days and 6 days respectively. These figures describe how the medicine moved through the body, not whether it produced any particular health outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02019550 · results posted 7 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 97 people in total across two groups. It was a crossover study, meaning participants each tried both injection devices — the Rebif Rebidose autoinjector and the Rebiject II autoinjector — for four weeks each, just in a different order depending on which group they were in. The trial was measuring how easy participants found each device to use, based on their answers to a questionnaire. The reported data shows that when participants were asked to rate each device's overall ease of use as "easy" or "very easy," the percentages varied depending on the device and the order in which it was used. Looking at overall results across both periods combined, 29.2% of participants rated the Rebif Rebidose as easy or very easy at one time point, rising to 39.6% at another, while 47.9% rated the Rebiject II as easy or very easy at one time point, dropping to 30.2% at another. For secondary measures, the reported data shows that when participants who had travelled overnight were asked about their satisfaction with using each device while away from home, only small numbers responded (for example, 10 people in each group agreed or strongly agreed they were satisfied). Regarding satisfaction with the time taken to complete an injection, roughly 47.8% to 50% of participants in each group agreed or strongly agreed they were satisfied with the time needed. For satisfaction with the number of steps involved, around 47.8% to 52.2% agreed or strongly agreed they were satisfied in one group, compared to 26% to 42% in the other. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02045732 · results posted 16 January 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02045732) enrolled just 4 participants in total — 1 person received a placebo (an inactive substance used for comparison) and 3 people received the study drug, PF-06342674, at a dose of 0.25 mg/kg. Of those, 2 participants in the drug group and none in the placebo group completed the study. The trial was primarily measuring a range of safety-related observations, including any unwanted medical events (called adverse events), changes in blood test results, changes in vital signs such as blood pressure and pulse, heart tracing (ECG) readings, and whether participants' immune systems produced antibodies against the study drug. The reported data shows that all 3 participants who received PF-06342674 experienced at least one adverse event that emerged during the treatment period, compared with 0 participants in the placebo group. Across those 3 participants, a total of 7 individual adverse events were recorded, all of which were graded as mild (meaning they did not significantly interfere with daily functioning). No serious adverse events and no withdrawals due to adverse events were reported in either group. All 3 participants in the drug group also showed at least one abnormal laboratory test result, and all 3 were found to have developed antibodies against the study drug. No participants in either group showed clinically significant changes in vital signs, and no participants in the drug group had abnormal ECG readings (1 participant in the placebo group did). Because the trial was so small — only 4 people — the reported figures are very limited in what they can indicate. It is worth noting that the reported data shows no efficacy (disease or treatment response) outcome measures were included in what was submitted to ClinicalTrials.gov; only the safety-related measurements described above were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT02217982 · results posted 6 January 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT02217982) enrolled a very small number of participants — 1 person in the Control Group and 4 people in the Treatment Arm, giving a total of 5 participants. The trial was measuring gastrointestinal (gut-related) symptoms — that is, things like stomach discomfort and diarrhoea — in people taking a medication called DMF. The main goal was to compare symptom severity between the two groups using a scoring tool called the MAGIS scale. The reported data shows that for the primary outcome — gut symptom severity — both the Control Group and the Treatment Arm recorded a score of 0. Similarly, for the secondary outcome measuring diarrhoea reduction, both groups also recorded a value of 0. It is worth noting that only 3 of the 4 participants in the Treatment Arm and none of the 1 participant in the Control Group completed the study, which means the numbers involved are extremely small. For a third pre-specified outcome looking at pre-existing gut conditions among participants, no measurement data was reported. Given the very small number of participants and the zero values recorded across the outcomes, it is difficult to draw any meaningful conclusions from these numbers alone. No data was reported for the pre-existing conditions outcome, so those results are simply not available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01480076 · results posted 4 November 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 901 people with multiple sclerosis (MS) who were all given fampridine, a tablet used to try to improve walking. Of those, 835 were included in the main analysis group, and 611 completed the full 12-month study. The trial was measuring changes in participants' self-reported quality of life and daily functioning over time, using several questionnaires. Based on their walking response to fampridine during the trial, participants were sorted into two groups — "responders" (those who showed a walking improvement) and "non-responders" — so that scores between the two groups could be compared. The reported data shows that the primary outcome focused on a physical wellbeing score (called the Physical Component Scale, or PCS) from a general health questionnaire, tracked across four check-in points. Among responders, the average score on this scale — which runs from 0 (worst) to 100 (best) — rose by 4.2 points at 3 months, 3.4 points at 6 months, 3.2 points at 9 months, and 2.9 points at 12 months from where it started, with higher numbers meaning a better result. The reported data also shows differences between responders and non-responders across several other questionnaires: responders recorded larger positive shifts on mental wellbeing scores and larger reductions (improvements) on two MS-specific scales measuring how much the condition affected daily physical and psychological functioning, compared to non-responders, whose scores showed little change or small fluctuations across the same period. For the daily activities questionnaire, the reported data shows responders recorded score reductions (indicating improvement) ranging from around 0.8 to 2.3 points across the four time points, while non-responders showed small increases (indicating worsening) at most time points. It is worth noting that this was a single-group trial with no placebo comparison group, so all participants received fampridine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01064401 · results posted 11 July 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01064401) enrolled 1,841 people with multiple sclerosis (MS) — 922 in the interferon beta-1a group and 919 in the daclizumab high yield process (HYP) group. The trial ran for up to 144 weeks (roughly three years) and was measuring things like how often MS relapses (episodes of new or returning symptoms) occurred, changes seen on brain scans, disability progression, and how participants felt the disease was affecting their daily life. The reported data shows the following numbers across the two groups. For the main (primary) outcome — the average number of confirmed relapses per year — the interferon beta-1a group had a reported rate of 0.39 relapses per year, while the daclizumab HYP group had a reported rate of 0.22 relapses per year. For brain scan activity (new or growing lesions detected by MRI up to week 96), the reported adjusted average number of lesions was 9.44 in the interferon beta-1a group and 4.31 in the daclizumab HYP group. Regarding disability worsening sustained over at least 12 weeks, the reported proportions were 0.203 (roughly 20 in every 100 participants) for interferon beta-1a and 0.162 (roughly 16 in every 100) for daclizumab HYP. The reported proportion of participants who had no confirmed relapse by week 144 was 0.508 (about 51 in 100) for interferon beta-1a and 0.673 (about 67 in 100) for daclizumab HYP. Finally, when measuring how much MS was physically affecting participants' daily lives using a patient-reported questionnaire (MSIS-29), 23% of the interferon beta-1a group and 19% of the daclizumab HYP group reported a meaningful worsening in their physical score at 96 weeks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00853762 · results posted 24 May 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT00853762) enrolled 74 people across four groups, each receiving a different dose or dosing approach of a medicine called atacicept: 16 people in the 25 mg group, 19 in the 75 mg group, 17 in the 150 mg group with a loading dose, and 22 in the 150 mg group without a loading dose. The trial was an extension study that focused on measuring physical monitoring data — such as blood pressure, pulse rate, body temperature, heart electrical activity (ECG), immune protein levels in the blood, and any unwanted health events (called adverse events) that occurred during the study period. Notably, the reported data shows that none of the participants formally "completed" the study under the trial's own definition, with all 74 recorded as not completing it. The reported data shows that when it came to unwanted health events (adverse events), between 5 and 13 people per group experienced at least one such event, with the 150 mg without-loading group having the highest count (13 out of 22). Serious adverse events — those involving hospitalisation, life-threatening situations, or significant disability — were reported in 2 to 6 people per group. One person in the 150 mg without-loading group was reported to have a malignancy (a cancer-related event); none were reported in the other three groups. Small changes in blood pressure, pulse, and body temperature were recorded across groups, but the reported figures were all modest in size. No ECG measurement data was reported in the submitted results. Regarding immune proteins in the blood (immunoglobulins IgA, IgG, and IgM), the reported data shows that a number of participants in each group had levels shift from normal at the start of the study to below-normal ranges during the study. The shifts were most commonly seen in IgM, where 7, 6, 14, and 7 people respectively across the four groups showed a worsening shift. The 150 mg with-loading group consistently showed the highest numbers of participants with shifts across all three protein types. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00642902 · results posted 24 May 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called atacicept (tested at three different doses — 25 mg, 75 mg, and 150 mg) compared to a placebo (a dummy treatment with no active ingredient) in people with multiple sclerosis. A total of 255 people were enrolled across the four groups (roughly 63–65 per group). The trial mainly measured brain lesions — areas of inflammation visible on a special type of MRI scan called a T1 gadolinium-enhancing scan — to see how many appeared over time in each group. The reported data shows that the average number of these brain lesions per person per scan was 3.07 in the placebo group, 2.26 in the 25 mg atacicept group, 2.30 in the 75 mg group, and 2.49 in the 150 mg group. For a secondary measure — the percentage of participants who had no relapses (no return or worsening of symptoms) during the 36-week treatment period — the reported figures were 81.0% for placebo, 69.8% for the 25 mg group, 71.9% for the 75 mg group, and 61.5% for the 150 mg group. The data also shows that treatment-emergent adverse events (unexpected medical occurrences that happened after starting treatment) were recorded in 46 placebo participants, 40 in the 25 mg group, 39 in the 75 mg group, and 52 in the 150 mg group. Serious adverse events were reported in 1, 3, 3, and 1 participants in those same groups respectively. It is worth noting that a relatively large proportion of participants in every group did not complete the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01490840 · results posted 12 May 2016
According to the results reported on ClinicalTrials.gov, this trial involved people with multiple sclerosis (MS) who were divided into two groups: one group received an e-training program ("E-training") and the other waited without the training ("Waiting"). In the first phase, 94 people started in the E-training group and 84 in the Waiting group. The trial was primarily measuring changes in fatigue levels, and also looked at muscle strength, leg endurance, and quality of life. The reported data shows that for the main measurement — a fatigue questionnaire called the Modified Fatigue Impact Scale, scored from 0 (no fatigue) to 84 (most fatigue) — the E-training group's score changed by −3.57 points from the start, while the Waiting group's score changed by −2.10 points. A negative number on this scale means the score moved in the direction of less fatigue. For a second fatigue questionnaire (the WEIMuS scale), the E-training group's score changed by −1.90 points and the Waiting group's by −1.12 points, again where a negative number reflects movement toward less fatigue. For the sit-to-stand muscle power test, the E-training group's result changed by +0.03 watts per kilogram of body weight, while the Waiting group's changed by +0.27. For leg strength endurance, the E-training group changed by +51.28 joules compared to +130.80 joules in the Waiting group. Quality-of-life scores (where lower is better) showed small changes in both groups across several areas, with the E-training group's total score shifting by −0.11 and the Waiting group's by −0.02. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01963611 · results posted 11 May 2016
According to the results reported on ClinicalTrials.gov, this trial enrolled 255 people in total across five groups. Participants were given one of four different doses of an investigational medicine called plovamer acetate (0.5 mg, 3 mg, 10 mg, or 20 mg) or a comparator medicine called Copaxone (20 mg), which is an existing treatment for multiple sclerosis. The trial was measuring brain scan activity — specifically looking at the number and type of lesions (areas of damage or inflammation) visible on MRI scans — as well as how often participants experienced relapses (periods of worsening MS symptoms). Notably, the reported data shows that none of the participants in any group were recorded as having completed the trial. The primary thing being measured was the average number of a particular type of brain lesion — called T1 gadolinium-enhancing lesions (bright spots on a special MRI scan that can indicate active inflammation) — seen per person, per scan. The reported data shows the averages across multiple sets of scans ranged from about 1.0 to 2.5 lesions per person per scan across the five groups, with some variation between groups and across different scan timepoints. For the secondary measures, the reported annualised relapse rate (an estimate of how many relapses a person might have in a year) was 0.3 for the lowest plovamer acetate dose group and 0.2 for all other groups including the Copaxone group. The reported data shows that the percentage of participants who remained relapse-free during the trial ranged from 86.3% in the lowest plovamer acetate dose group up to 94.2% in the 10 mg and 20 mg groups, with 90.0% in the Copaxone group. Additional MRI lesion counts (new active lesions, enlarging lesions, and so-called "black holes") were also reported across the groups, with figures varying across different scan timepoints; some later timepoint data appears only partially reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01874145 · results posted 14 January 2016
According to the results reported on ClinicalTrials.gov, this trial looked at two different dosing schedules of a medication called glatiramer acetate (GA), used for multiple sclerosis. One group received a 20 mg/mL dose every day during the first part of the trial (the "core period"), then switched to a 40 mg/mL dose three times a week in the second part (the "extension period"). The other group received the 40 mg/mL dose three times a week throughout the whole trial. In total, 101 people started in the first group and 108 in the second. The trial's main focus was on measuring reactions at or around the injection site — such as redness, chest tightness, flushing, or anxiety shortly after injecting — across both the core and extension periods. The reported data shows that during the core period, the group taking daily injections experienced an estimated rate of about 70 injection-related reactions per person per year, while the group taking three-times-a-week injections had an estimated rate of about 35 reactions per person per year. For the extension period — when the daily-injection group had switched to the three-times-a-week schedule — the reported rate was about 23 reactions per person per year for the switchers, compared to about 28 per person per year for those who had been on the three-times-a-week schedule all along. The trial also measured participants' self-reported sense of how MS affected their physical and psychological wellbeing using a questionnaire (scored so that a lower number means less impact). The reported data shows small changes from the starting score in both groups, with the figures close to zero in most cases, meaning little average change was recorded over the measurement period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01405820 · results posted 29 July 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01405820) tested different ways of giving the medicine natalizumab to people with multiple sclerosis. A total of 290 people were enrolled across six groups, each receiving a different dose (300 mg or 150 mg), delivery method (into a vein, known as intravenous or IV, or by injection under the skin, known as subcutaneous or SC), and timing (every 4 weeks or every 12 weeks). The trial had two phases: a randomised treatment period — where participants were assigned to one of the six groups — followed by an open-label period, where everyone knew which treatment they were receiving. The main thing the trial measured was the total number of new or growing brain lesions (areas of change in the brain visible on MRI scans) counted up to 60 weeks. The reported data shows that the group receiving 300 mg by vein every 4 weeks had an average of 0.23 lesions per person, and the group receiving 300 mg by injection under the skin every 4 weeks had an average of 0.02 lesions per person. By comparison, the groups receiving treatment every 12 weeks had noticeably higher average lesion counts: 3.84 (300 mg IV), 3.08 (300 mg SC), 6.09 (150 mg IV), and 6.44 (150 mg SC). It is worth noting that a large proportion of participants in the every-12-weeks groups did not complete the randomised treatment period, which may affect how these figures should be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01874340 · results posted 1 June 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT01874340) tested three different doses of a medicine called AIN457 (15 mg/kg, 7 mg/kg, and 3 mg/kg) compared to a placebo (an inactive treatment) in people with a neurological condition. A total of 28 people took part — 6 in the highest-dose group, 8 in each of the two lower-dose groups, and 6 in the placebo group. The trial was designed to measure things like brain scan changes and relapse rates, but it was stopped early before it could be completed. Because of that early termination, only 1 person (in the placebo group) formally completed the study. The reported data shows that because the trial ended early, the main things it set out to measure — including changes seen on brain scans and how often relapses occurred — were not able to be properly analysed, and no numerical results for those outcomes were submitted to ClinicalTrials.gov. The only outcome measure with numbers reported was a count of participants who experienced adverse events (unwanted health events that occurred during the trial, which may or may not be related to the medicine). The reported data shows that in the 15 mg/kg group, 1 out of 6 participants had an adverse event; in the 7 mg/kg group, 3 out of 8 did; in the 3 mg/kg group, 3 out of 8 did; and in the placebo group, 2 out of 6 did. Additional rows of figures were submitted for this measure, but several values were recorded as zero across all groups, and the data as submitted does not clearly label what each row represents beyond the overall counts noted above. It is important to note that because the trial closed before enough participants completed it, the results as a whole are very limited and cannot be used to draw conclusions about whether AIN457 performed differently from placebo in any of the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00297232 · results posted 29 May 2015
According to the results reported on ClinicalTrials.gov, this trial involved 1,094 people with multiple sclerosis (MS) who all received the medication natalizumab — there was no comparison group. The trial was measuring changes in disability over time using a standard MS disability scale called the EDSS, which runs from 0 (no disability) to 10 (death due to MS). The trial tracked how long it took for participants' disability scores to either worsen or improve in a meaningful and lasting way. Of the 1,094 people who started, 489 completed the study and 605 did not complete it; the reasons for not completing were not detailed in the data provided. The reported data shows that, on average, it took approximately 121.9 weeks (roughly 2 years and 4 months) before a worsening in disability score was confirmed and sustained for at least 24 weeks, and approximately 130.1 weeks (roughly 2 years and 6 months) before a worsening was confirmed and sustained for at least 48 weeks. These figures represent the median time — that is, the point at which half of participants had reached that level of change. The reported data also shows that, among participants who started with a disability score of 2.0 or above, the average time to a confirmed and sustained improvement in their disability score (lasting at least 24 weeks) was approximately 48.1 weeks (roughly 11 months). It is worth noting that because this trial had only one group — everyone received natalizumab — these numbers cannot be directly compared to an untreated group within this study. The data describes what was observed and measured, not whether the medication caused those observations. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01414634 · results posted 8 April 2015
According to the results reported on ClinicalTrials.gov, this trial tested a treatment called ETIMS across eight different dose levels, ranging from very small to much larger amounts. A total of 9 people took part — one person at each of seven dose levels, and two people at one of the middle dose levels. All 9 participants completed the study. The trial was designed as a dose-escalation study, meaning researchers started with a low dose and gradually increased it to observe what happened at each level. The main thing being measured was the number of adverse events (that is, any unwanted or unexpected health events that occurred during the trial) as a way of tracking safety and tolerability. The reported data shows that across all participants combined, a total of 14 adverse events were recorded during the trial. This figure covers all dose groups together, as the results were reported as a single combined total rather than broken down by each dose level. No further detail about the nature or severity of these adverse events was included in the structured data submitted to ClinicalTrials.gov. The secondary outcome measures, if any were assessed, were not reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00548405 · results posted 8 January 2015
According to the results reported on ClinicalTrials.gov, this trial (NCT00548405) enrolled 840 people across three groups: 231 were assigned to interferon beta-1a (an existing MS treatment used for comparison), 436 to alemtuzumab at a 12 mg dose, and 173 to alemtuzumab at a 24 mg dose. The trial was measuring two main things over two years: how many participants experienced a lasting worsening of their disability (as measured by a standard MS disability scale called the EDSS, which runs from 0 to 10), and how often participants had MS relapses (episodes of new or worsening symptoms). Note that the primary outcome data was only reported for the interferon beta-1a and alemtuzumab 12 mg groups. The reported data shows that, for the sustained disability worsening outcome, an estimated 21.13% of participants in the interferon beta-1a group and 12.71% in the alemtuzumab 12 mg group reached that threshold over the study period. For relapses, the reported average number of relapses per person per year was 0.52 in the interferon beta-1a group and 0.26 in the alemtuzumab 12 mg group. Among the secondary measures, the reported data shows that approximately 46.70% of the interferon beta-1a group and 65.38% of the alemtuzumab 12 mg group were free of relapses at the two-year mark. On the disability scale, the interferon beta-1a group's average score went up by 0.21 points from their starting score, while the alemtuzumab 12 mg group's average score went down by 0.20 points. Brain scan measurements of MS lesion volume showed an average increase of about 2.41% in the interferon beta-1a group and an average decrease of about 1.12% in the alemtuzumab 12 mg group. Results for the 24 mg alemtuzumab group were not reported for the primary outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00622700 · results posted 19 December 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 618 people across three groups during the main (core) treatment period: 197 received a placebo (a dummy treatment with no active ingredient), 205 received a lower dose of teriflunomide (7 mg), and 216 received a higher dose (14 mg). The trial was measuring how long it took for participants — who had each experienced a single episode of neurological symptoms that could be an early warning sign of multiple sclerosis (MS) — to be diagnosed with clinically definite MS. A portion of participants who completed the core period then continued into an extension phase. The trial also looked at relapse rates and changes seen on brain MRI (brain scans). The reported data shows that, for the primary outcome — the estimated probability of being diagnosed with clinically definite MS by the end of the study (at 108 weeks) — the figures were 35.9% in the placebo group, 27.6% in the 7 mg group, and 24.0% in the 14 mg group. For a broader measure of MS diagnosis that also included MRI scan criteria, the reported probabilities at 108 weeks were 87.0% (placebo), 73.3% (7 mg), and 71.5% (14 mg). The reported average relapse rate per year was 0.284 for placebo, 0.190 for the 7 mg group, and 0.194 for the 14 mg group. Brain MRI scans also recorded the number of active lesions (areas of inflammation visible on the scan) per scan: 0.953 for placebo, 0.749 for the 7 mg group, and 0.395 for the 14 mg group. Changes in total lesion volume on the brain scans and the volume of active lesions were also reported, with the figures for all three groups described as small numerical differences; full details of those figures are available in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00530348 · results posted 24 November 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT00530348) compared two treatments for multiple sclerosis (MS) — interferon beta-1a and alemtuzumab. A total of 581 people started the study (195 in the interferon beta-1a group and 386 in the alemtuzumab group), and the trial ran for two years. The study was primarily measuring two things: the proportion of participants whose disability worsened in a sustained way over at least six months, and how often participants experienced relapses (episodes of new or returning MS symptoms). The reported data shows that, for the main disability measure, an estimated 11.12% of participants in the interferon beta-1a group and 8.00% in the alemtuzumab group experienced a sustained worsening of disability over the study period. For relapses, the reported average rate was approximately 0.39 relapses per person per year in the interferon beta-1a group, compared with 0.18 in the alemtuzumab group. Among the secondary measures, the reported data shows that around 58.69% of the interferon beta-1a group and 77.59% of the alemtuzumab group were free of relapses at the two-year mark. Both groups showed a similar small change in their disability scale scores at two years (a change of -0.2 in both groups, meaning scores were slightly lower than at the start). Brain lesion volume, as measured by MRI scan, was reported to have decreased by approximately 6.68% in the interferon beta-1a group and 10.28% in the alemtuzumab group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01873417 · results posted 11 November 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 237 people, all of whom received a treatment called dimethyl fumarate (DMF). Of these, 233 were included in the safety analysis and 202 completed the study. The trial was focused on measuring stomach and gut (gastrointestinal, or "GI") symptoms that participants experienced while taking DMF. Researchers used two questionnaire-style tools — each scored from 0 to 10, where 0 means no symptoms and 10 means the worst possible symptoms — to record how severe any GI episodes were, how long they lasted, and whether participants used any medicines to relieve those symptoms. The reported data shows that, on the two symptom-severity scales used, participants scored an average worst severity of 4.8 out of 10 on one scale and 4.7 out of 10 on the other. According to the results reported on ClinicalTrials.gov, 54.1% of participants who reported GI symptoms went on to use some form of medicine to relieve those symptoms. For those who did use such medicines, the reported median duration (that is, the middle value when all episode lengths are lined up) of individual GI episodes varied by symptom type, ranging from as short as 0.4 hours (for vomiting) up to 6.0 hours (for constipation), with most other symptoms lasting roughly 1.6 to 3.0 hours. The reported data also shows that 57 participants used at least one type of GI symptom-relief medicine during the study, with antacids and similar stomach medicines being the most commonly reported categories. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01440101 · results posted 21 October 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01440101) involved 106 participants across two parts. Twelve people took part in Part A, an open-label phase where everyone received natalizumab (meaning all participants knew what treatment they were getting). Part B involved 94 people split into two groups: 47 received natalizumab and 47 received a placebo (an inactive treatment), with neither participants nor researchers knowing who received which — this is known as a "double-blind" design. The trial was measuring brain scan changes (using a type of MRI scan that can highlight active areas of inflammation), relapse rates, and health events experienced by participants. The reported data shows that in Part A, out of 12 participants who received open-label natalizumab, 8 experienced some kind of adverse event (an unexpected medical occurrence during the study), 4 experienced a serious adverse event, and 1 experienced a severe adverse event. For Part B, the reported rate at which new active lesions (areas of new inflammation visible on brain scans) developed over 24 weeks was 0.352 lesions per week in the placebo group and 0.058 lesions per week in the natalizumab group. The reported data also shows the placebo group accumulated an average of 8.5 new active lesions over 24 weeks compared to 1.5 in the natalizumab group. For relapses, the reported annualised rate (calculated to estimate how many relapses per year) was 1.727 in the placebo group and 0.532 in the natalizumab group. Additional brain scan measurements reported for the placebo group versus the natalizumab group included an average of 7.4 versus 1.2 gadolinium-enhancing lesions (spots that light up on a special MRI scan, suggesting active inflammation) and 1.1 versus 0.3 new or growing lesions of another type (called T2-hyperintense lesions) over the 24-week period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01517282 · results posted 13 October 2014
According to the results reported on ClinicalTrials.gov, this trial tested a drug called MOR103 in people with relapsing-remitting or secondary progressive multiple sclerosis (MS). A total of 32 people took part — split into three groups receiving different doses of MOR103 (0.5 mg/kg, 1.0 mg/kg, or 2.0 mg/kg) and one group receiving a placebo (an inactive treatment used for comparison). The trial was primarily measuring how often participants experienced unwanted health events (called adverse events) after receiving the study drug. It also tracked how the drug moved through the body over time, and whether participants developed antibodies against the drug (which can sometimes affect how a drug behaves). The reported data shows that when it came to any unwanted health events during the study, 100% of participants in the 0.5 mg/kg and 1.0 mg/kg dose groups, 88.9% in the 2.0 mg/kg group, and 100% in the placebo group recorded at least one such event. For serious unwanted health events specifically, the reported figures were 75% (0.5 mg/kg), 50% (1.0 mg/kg), 33.3% (2.0 mg/kg), and 83.3% (placebo). Regarding the drug's levels in the blood, the reported data shows that peak concentrations increased with higher doses, and levels appeared to be reached within approximately 1.3 to 2 hours after dosing. The reported data also shows that 100% of participants across all three MOR103 dose groups tested negative for antibodies against the drug at all follow-up time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01058005 · results posted 13 August 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01058005) enrolled 84 participants across three groups: 38 received Natalizumab, 25 received Interferon Beta-1a, and 21 received Glatiramer Acetate — all of which are medicines used in the context of multiple sclerosis. The trial's main focus was measuring how often participants experienced serious adverse events (that is, significant medical incidents such as hospitalisation, life-threatening events, lasting disability, or death) while taking these treatments. The reported data shows that very few participants experienced a serious adverse event during the study. In the Natalizumab group, 1 out of 38 participants had a serious adverse event. In the Interferon Beta-1a group, 1 out of 25 participants had a serious adverse event. In the Glatiramer Acetate group, 0 out of 21 participants had a serious adverse event. It is also worth noting that almost no participants formally completed the study — only 1 person (in the Glatiramer Acetate group) was recorded as having completed it — though the reasons for this were not reported in the data provided here. No secondary outcome measures were included in the submitted results data, so those figures cannot be described here. It is also important to note that this trial measured the occurrence of serious adverse events as its primary goal; the reported numbers above reflect only what was recorded and submitted to the registry. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00876447 · results posted 13 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 388 adults in total — 185 in a group receiving 300 units of botulinum toxin type A (commonly known as Botox), and 203 in a group receiving 200 units of the same treatment. The trial was measuring changes in bladder leakage (involuntary loss of urine) over time. Participants kept a diary recording how many times per day they experienced leakage, and the trial tracked how that number changed after treatment. Of those who started, 105 in the 300-unit group and 122 in the 200-unit group completed the study. The reported data shows that, at the start of the study, participants in both groups were experiencing roughly 4 to 5 involuntary leakage episodes per day on average. Across five separate measurement time points reported, the 300-unit group showed an average daily reduction of between 3.3 and 3.7 episodes, while the 200-unit group showed a reduction of between 3.2 and 3.6 episodes per day. These figures represent the change from the starting point — a negative number means fewer leakage episodes were recorded compared to the beginning of the study. The reported data also shows a secondary measure — a quality-of-life questionnaire called the I-QOL, scored from 0 (worst) to 100 (best). Both groups started with scores of around 34 out of 100. The reported change from that starting point was an increase of approximately 32 points in the 300-unit group and approximately 30 points in the 200-unit group, meaning both groups scored higher on the quality-of-life measure at the time of this assessment than they did at the beginning. No other secondary outcome data was reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00420212 · results posted 2 June 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,234 people across three groups: 408 received a placebo (dummy treatment), 410 received BG00012 (also known as dimethyl fumarate) at a dose of 240 mg twice daily, and 416 received the same drug three times daily. The trial ran for two years and was measuring things like the proportion of participants who had a relapse (a return or worsening of neurological symptoms), changes seen on brain scans, and changes in disability scores — all in the context of multiple sclerosis (MS). The reported data shows that, for the main outcome, the estimated proportion of participants who experienced a relapse over the two years was 0.461 (roughly 46 in every 100) in the placebo group, compared with 0.270 (about 27 in 100) in the twice-daily group and 0.260 (about 26 in 100) in the three-times-daily group. For the rate of relapses per year, the placebo group was reported at 0.364, while the twice-daily and three-times-daily groups were reported at 0.172 and 0.189 respectively. On brain scans, the average number of new or growing lesions (areas of concern visible on MRI) over two years was reported as 17.0 in the placebo group, 2.6 in the twice-daily group, and 4.4 in the three-times-daily group. A separate type of brain scan lesion (called gadolinium-enhancing lesions, which can indicate active inflammation) averaged 1.8 in the placebo group, 0.1 in the twice-daily group, and 0.5 in the three-times-daily group. For disability progression — measured on a standard scale where a higher score means greater disability — the estimated proportion of participants whose disability worsened (confirmed at 12 weeks) was reported as 0.271 in the placebo group, 0.164 in the twice-daily group, and 0.177 in the three-times-daily group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01252355 · results posted 22 May 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01252355) involved 534 people with multiple sclerosis — 177 in the placebo group, 178 in the teriflunomide 7 mg group, and 179 in the teriflunomide 14 mg group. All participants also received a standard MS medicine called interferon-beta (IFN-beta). The trial measured how often relapses (sudden worsening of MS symptoms) occurred, as well as changes visible on brain scans. It is worth noting that the data shows zero participants were recorded as having "completed" the study in the formal sense, and all participants were counted as "not completed" — the reasons for this are not explained in the reported data. The reported data shows that the average number of relapses per year (called the "annualised relapse rate") was 0.298 for the placebo-plus-IFN-beta group, 0.242 for the 7 mg teriflunomide group, and 0.238 for the 14 mg teriflunomide group. For brain scan findings, the number of active (so-called "gadolinium-enhancing") lesions per scan was reported as 0.542 in the placebo group, 0.257 in the 7 mg group, and 0.158 in the 14 mg group. Regarding the estimated probability of having no relapse at 72 weeks, the reported figures were approximately 58% for the placebo group, 78% for the 7 mg group, and 73% for the 14 mg group. The data for disability progression over 12 weeks was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT01964547 · results posted 2 May 2014
According to the results reported on ClinicalTrials.gov, this trial (NCT01964547) enrolled 121 people with multiple sclerosis — 62 in the Sativex group and 59 in the placebo (inactive treatment) group. Around 50 and 48 people respectively completed the trial. The study was measuring several things related to multiple sclerosis symptoms, including thinking speed and mental flexibility (using a test called the PASAT), mood (using a depression questionnaire called the BDI-II), muscle stiffness (called spasticity, measured by a clinician rating scale called the Modified Ashworth Scale), and how patients, caregivers, and doctors rated any change in spasticity over time. The reported data shows that for the main (primary) outcome — change in PASAT thinking-speed score from the start to the end of treatment — both groups recorded an average improvement of 6.8 points out of a possible 60. For the depression questionnaire (BDI-II), the Sativex group's average score fell by 3.1 points and the placebo group's fell by 2.4 points (a lower score indicates less severe symptoms on this scale). For the muscle stiffness scale (Modified Ashworth), the Sativex group's average score fell by 10.6 points and the placebo group's fell by 7.7 points (again, a lower score indicates less stiffness). For the global impression ratings — where patients, caregivers, and doctors each rated spasticity change on a seven-point scale from "very much worse" to "very much better" — the reported data shows that in the Sativex group, the most common patient rating was "minimally worse" (24 out of 58 patients), while in the placebo group, the most common patient rating was "no change" (27 out of 56 patients). Similar patterns were seen in the caregiver and physician ratings, though the data was not reported for all participants in those categories. It is worth noting that the reported numbers alone do not tell us whether any differences between the two groups were considered statistically meaningful (that is, unlikely to be due to chance) — that information was not included in the structured results data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00220779 · results posted 11 April 2014
According to the results reported on ClinicalTrials.gov, this trial involved 128 people with multiple sclerosis (MS) across three groups. Forty-five participants received a lower dose of an intravenous immunoglobulin treatment called IGIV-C, 42 received a higher dose of the same treatment, and 41 received a placebo (an inactive substance containing a small amount of albumin, a common blood protein). The trial was primarily measuring how many participants in each group went without a relapse — meaning a return or worsening of MS symptoms lasting at least 48 hours — over the course of the study. By the end, 38 people in each active treatment group and 37 in the placebo group had completed the trial. The reported data shows the following for the main outcome — the percentage of participants who remained relapse-free: in the lower-dose IGIV-C group, approximately 56.8% were relapse-free, while around 43.2% experienced a relapse. In the higher-dose IGIV-C group, approximately 59.5% were relapse-free, and around 40.5% had a relapse. In the placebo group, approximately 68.3% were relapse-free, and around 31.7% experienced a relapse. A secondary outcome measuring changes seen on MRI (brain scans that detect areas of MS activity) was listed in the trial record, but no numerical results for that measure were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01499667 · results posted 4 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 142 people with multiple sclerosis (50, 42, and 50 in each group respectively) who were switching from a medicine called natalizumab to another called fingolimod (also known as FTY720). The key question being studied was how many new or growing brain lesions — areas of damage visible on MRI brain scans — appeared during different "washout" periods (gaps between stopping one medicine and starting the other) of 8, 12, or 16 weeks. Around 112 participants completed the study across the three groups. The reported data shows that, for the main outcome — the number of active brain lesions from the last natalizumab dose through 8 weeks of fingolimod treatment — the 8-week washout group averaged 2.1 lesions, the 12-week washout group averaged 1.7 lesions, and the 16-week washout group averaged 8.2 lesions. The reported data also shows that during the washout period alone (before starting fingolimod), average lesion counts were 0.4, 2.1, and 3.6 for the 8-, 12-, and 16-week groups respectively. Over the full 24 weeks from the last natalizumab dose, the reported averages were 3.2, 4.4, and 7.7 lesions across the three groups. For disability scores (measured on a standard 0–10 scale where higher means greater disability), the reported changes from the starting point were small, ranging from −0.13 to +0.23 across groups and time points. For a measure of a different type of brain lesion (gadolinium-enhancing T1 lesions), some figures were reported but one data point for the 16-week group was listed as not available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00122954 · results posted 14 January 2014
According to the results reported on ClinicalTrials.gov, this trial involved 39 people in total — 18 assigned to a placebo and 21 assigned to omega-3 fatty acids. Of those, 16 in the placebo group and 18 in the omega-3 group completed the study. The trial was measuring changes in depression symptoms and quality of life. The main thing researchers were looking at was whether participants' scores on a standard depression scale (called the MADRS, which runs from 0 to 60, with higher scores meaning more severe depression) improved by 50% or more over the course of the trial. The reported data shows that in the placebo group, 45.5% of participants reached that 50% or greater improvement on the depression scale, while in the omega-3 group, 47.4% did. For the secondary outcome — a quality-of-life questionnaire called the SF-36, where higher scores mean better function — the reported data shows two sets of changes. One measure (which appears to reflect the mental component) showed an average change of −0.8 in the placebo group and +1.6 in the omega-3 group. The other measure (which appears to reflect the physical component) showed an average change of +4.2 in the placebo group and +1.5 in the omega-3 group. It is worth noting that the SF-36 results were reported as two separate figures per group, but the trial record does not clearly label which figure corresponds to which subscale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00913510 · results posted 6 January 2014
According to the results reported on ClinicalTrials.gov, this trial involved two small groups of participants: 13 people who used a type of catheter called LoFric Primo (a device used to empty the bladder, known as clean intermittent catheterisation or CIC), and 7 people who took anticholinergic medication (a type of medicine commonly used to help with bladder control). The trial was measuring how the frequency of urination per day changed over 8 weeks, with participants keeping a diary of how often they went to the toilet. It is worth noting that the number of people who completed the study was quite small — only 5 out of 13 in the catheter group and 3 out of 7 in the medication group finished the trial. The reported data shows that, on average, the catheter group had approximately a 9.09% reduction in the number of times they urinated per day over the 8 weeks, while the medication group had approximately a 6.41% reduction over the same period. These figures represent the percentage change compared to where each group started (their "baseline"). No other outcome measures were reported in the submitted data — for example, no secondary outcome data was included in the results as submitted to ClinicalTrials.gov. Given the very small number of participants who completed the study, these numbers should be interpreted with considerable caution. The reported data does not allow conclusions to be drawn about whether one approach performed better than the other, and no safety or side-effect data was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00641537 · results posted 2 December 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00641537) involved a medicine called cladribine and enrolled 867 participants across eight different treatment groups, who received varying doses of cladribine, placebo (a dummy treatment), or combinations of both over a 96-week period, followed by an optional 24-week follow-up. The trial was primarily focused on measuring changes in blood and liver markers — things like white blood cell counts, platelet levels, and liver enzymes — to track how these values shifted over the course of treatment. The reported data shows that, when looking at the most serious category of blood or liver abnormalities (described as "Grade 4," meaning life-threatening or disabling), between 0% and 3.2% of participants across the different groups recorded at least one such event, with the higher figures seen in groups receiving higher or longer doses of cladribine. For changes in blood cell counts at around week 120, the reported data shows that lymphocyte counts (a type of white blood cell) decreased in most groups, with the largest average drop — 34.0 units (measured as billions of cells per litre) — seen in the Placebo/Cladribine Low Dose group. Changes in other blood markers, liver enzymes, and bilirubin were generally small across all groups, with figures close to zero in most cases. Regarding unwanted medical events during the trial, the reported data shows that between 71 and 194 participants per group experienced at least one treatment-emergent adverse event (meaning any medical issue that appeared or got worse after starting the study drug), and between 8 and 25 participants per group experienced a serious adverse event. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00147446 · results posted 10 September 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 121 people with multiple sclerosis (MS) — 60 in a stress management therapy group and 61 in a "wait list" control group (meaning they waited to receive the therapy rather than receiving it straight away). All 121 participants completed the study. The trial was measuring brain activity related to MS using MRI scans taken between weeks 8 and 24. Specifically, it looked at two types of brain changes: "Gadolinium-enhancing" lesions (spots on an MRI scan that signal a temporary breakdown in the brain's protective barrier, used as a marker of active MS disease activity), and new or enlarged T2 lesions (spots linked to more lasting changes in the brain). The reported data shows the following for the primary measure — the number of Gadolinium-enhancing lesions detected between weeks 8 and 24: in the stress management therapy group, 46 out of 60 participants had zero lesions, 5 had one lesion, 2 had two lesions, 2 had three lesions, and 5 had more than three lesions. In the wait list control group, 33 out of 61 participants had zero lesions, 13 had one lesion, 6 had two lesions, 6 had three lesions, and 3 had more than three lesions. For the secondary measure — new or enlarged T2 lesions over the same period — the stress management therapy group had 43 of 60 participants with zero lesions, 8 with one, 1 with two, 1 with three, and 7 with more than three. In the wait list control group, 26 of 61 had zero lesions, 9 had one, 9 had two, 7 had three, and 10 had more than three. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00670449 · results posted 4 September 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00670449) involved 143 participants in total across four groups: 47 people received fingolimod 0.5 mg, 46 received fingolimod 1.25 mg, 27 were in a placebo group later switched to 0.5 mg, and 23 were in a placebo group later switched to 1.25 mg. The trial was measuring brain scan activity and relapse rates in people with multiple sclerosis (MS), using MRI scans to look for signs of inflammation in the brain, and tracking how often participants experienced MS relapses (episodes of worsening symptoms) over the course of the study. The reported data shows that for the primary outcome — the percentage of participants whose MRI scans showed no active inflamed brain spots (called "Gd-enhanced lesions") — figures ranged broadly across the different time points and groups. For example, at one time point, 88.6% of the 0.5 mg group, 97.9% of the 1.25 mg group, and 58.0% of the placebo group had no such lesions visible on their scans. For the secondary outcomes, the reported data shows that the estimated number of confirmed relapses per year at the start of the study was 0.539 for the 0.5 mg group, 0.404 for the 1.25 mg group, and 1.131 for the placebo group, with these figures changing at later time points across all groups. At the end of the study, 45.2% of the 0.5 mg group, 62.1% of the 1.25 mg group, and 48.3% of the placebo group were reported as having had no relapses at all. For disability progression — measured using a standard 0–10 neurologist-rated scale where higher scores mean greater disability — the reported data shows that 74.3% (0.5 mg) and 82.4% (1.25 mg) of participants showed no confirmed worsening over three months, compared with 90.6% in the placebo group, though these figures shifted at the six-month mark and across later periods of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00436826 · results posted 1 July 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT00436826) enrolled 172 participants across its main double-blind phase, with 124 receiving cladribine (3.5 mg/kg) combined with interferon-beta, and 48 receiving a placebo combined with interferon-beta. The trial was primarily measuring blood-related and liver-related side effects — specifically how often participants experienced severe or very severe abnormalities in blood cell counts and liver markers — as well as the number of participants who experienced adverse events (unwanted medical occurrences) overall during the study period. The reported data shows that in the double-blind phase, 119 out of 124 participants in the cladribine group experienced at least one treatment-emergent adverse event (an unwanted medical occurrence that appeared or worsened after starting treatment), compared with 36 out of 48 in the placebo group. Serious adverse events were reported in 12 participants in the cladribine group and 5 in the placebo group. Regarding severe blood or liver abnormalities (graded as severe or life-threatening on a standard medical scale), the reported data shows that approximately 63.7% of participants in the cladribine group experienced severe or worse low lymphocyte counts (a type of white blood cell), compared with around 2.1% in the placebo group. For infections and infestations specifically, 61.3% of the cladribine group and 54.2% of the placebo group were reported to have experienced such events. The reported data also shows that blood cell counts, including lymphocytes and white blood cells, declined more in the cladribine group over the course of the study compared with the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00836719 · results posted 27 June 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom received a treatment called Polyphenon E (a green tea extract). All 10 participants completed the study. The trial was measuring two things: whether any participants experienced serious unwanted medical events (called serious adverse events), and whether there were any changes in a brain chemical called NAA — a marker that can be measured using a type of brain scan known as MR spectroscopy. NAA levels are sometimes used as an indicator of nerve cell health in the brain. The reported data shows that none of the 10 participants (zero out of ten) experienced a serious adverse event during the trial. For the brain scan measurement, the reported data shows an average change of 10% in NAA levels from the start of the trial to the end, after adjusting for another brain chemical called creatine, which is used as a reference point to make the measurement more reliable. No additional breakdown of this figure — such as individual results or the range of results across participants — was reported in the data provided to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01071083 · results posted 30 January 2013
According to the results reported on ClinicalTrials.gov, this trial (NCT01071083) looked at people with multiple sclerosis (MS) who had recently had a flare-up of their condition. A total of 175 people were enrolled across five groups: 45 received natalizumab (an infused MS medicine), 42 received an intravenous (into-the-vein) placebo (an inactive dummy treatment given the same way), 17 received interferon β-1a, 17 received glatiramer acetate, and 54 received methylprednisolone (a steroid). Not everyone finished the study — the numbers who completed it were 43, 35, 12, 15, and 46 in those same groups respectively. The trial was measuring how quickly signs of MS activity returned, either on brain scans or as a new clinical episode (relapse), after each treatment was given. The reported data shows the main result as the percentage of participants in each group who showed returning MS activity — either on MRI (brain scan) or as a clinical relapse — during the study. In the natalizumab group, 4.7% of participants met those criteria. By comparison, 60.5% in the placebo group, 28.6% in the interferon β-1a group, 53.3% in the glatiramer acetate group, and 54.8% in the methylprednisolone group met those criteria. For the secondary measure — looking at brain scan activity alone (without counting clinical relapses) — the reported figures were 0.0% for natalizumab, 52.5% for placebo, 8.3% for interferon β-1a, 49.7% for glatiramer acetate, and 46.1% for methylprednisolone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00883337 · results posted 6 November 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 324 people across three groups. All participants had already taken part in an earlier study comparing teriflunomide (at two different doses — 7 mg and 14 mg) with an injectable medicine called interferon beta-1a (IFN-β-1a). This follow-on trial then switched everyone to teriflunomide 14 mg and tracked them over two periods: a core treatment period and a longer extension period. The trial was mainly measuring how many participants experienced a "failure" — defined as either having a confirmed MS relapse (a return or worsening of symptoms lasting at least 24 hours) or permanently stopping treatment, whichever came first. The reported data shows that during the core treatment period, the number of participants who experienced a "failure" was 53 in the teriflunomide 7 mg group, 42 in the teriflunomide 14 mg group, and 44 in the interferon beta-1a group, while 56, 69, and 60 participants respectively were recorded as free of failure. When looking at the estimated chance of experiencing a failure over time, the reported figures at the 96-week mark were approximately 59% for the 7 mg group, 41% for the 14 mg group, and 44% for the interferon beta-1a group. The reported average number of relapses per year was 0.41 for the 7 mg group, 0.26 for the 14 mg group, and 0.22 for the interferon beta-1a group. The reported data also shows results from questionnaires about fatigue and treatment satisfaction. On the fatigue scale (where higher scores mean more impact on daily life), average changes from the starting point were small across all groups — 0.97 points for the 7 mg group, 4.10 for the 14 mg group, and 9.10 for the interferon beta-1a group. On the treatment satisfaction questionnaire (where higher scores mean greater satisfaction), the two teriflunomide groups reported higher scores for convenience and side effects compared with the interferon beta-1a group, though all scores across dimensions are as reported and no interpretation of their meaning is made here. Regarding unwanted events recorded during the study, 103, 102, and 97 participants respectively across the three groups reported at least one adverse event, with no deaths reported in any group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00404352 · results posted 24 September 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 517 people in total across its main double-blind phase, with 171 assigned to receive a drug called RNF (rebif novel formulation) three times a week, 175 assigned to receive RNF once a week, and 171 assigned to receive a placebo (an inactive treatment). All participants had experienced their first episode of symptoms that could suggest the beginnings of multiple sclerosis (MS). The trial was primarily measuring how long it took for participants to be formally diagnosed with MS according to a standard set of diagnostic criteria. The study ran in several phases, including a blinded phase of up to 24 months and later open-label and extension phases where some participants continued on active treatment for up to 36 months. The reported data shows that, for the primary outcome during the double-blind phase, the median time (that is, the midpoint — half of participants crossed this threshold earlier, half later) until a diagnosis of MS was reached was 310 days in the three-times-weekly RNF group, 182 days in the once-weekly RNF group, and 97 days in the placebo group. For the secondary outcome measuring time to a "clinically definite" MS diagnosis — based on a second attack or a sustained worsening on a disability scale — the reported data shows "NA" (not available) for all three groups in both the 24-month and 36-month phases, meaning those specific figures were not reported. For MRI-based measures in the extension phase, the reported data shows the average number of new or active brain lesions per person per scan ranged from 0.00 to 1.56 depending on the group and lesion type, and changes in lesion volume from the start of the study to month 36 also varied across groups, with figures not reported as directly comparable without further context. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00678795 · results posted 21 September 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 135 people — 67 received Sativex (a cannabis-based mouth spray) and 68 received a placebo (a dummy spray with no active ingredient). The trial was looking at bladder problems in people with neurogenic overactive bladder, a condition where nerve damage causes the bladder to behave unpredictably. Participants kept a daily diary over several weeks, recording things like leakage episodes, sudden urges to urinate, nighttime toilet trips, and pad use. They also answered questions about how their bladder condition affected their quality of life and rated their overall bladder problems on a scale of 0 to 10. The reported data shows that, for the main thing being measured — the average number of daily leakage (incontinence) episodes — both groups recorded a reduction from their starting point. The Sativex group reported a reduction of about 1.08 episodes per day, and the placebo group reported a reduction of about 0.99 episodes per day. For the additional measures, the Sativex group reported reductions of around 1.91 fewer daily urgency episodes (placebo: 1.12), 0.55 fewer nighttime toilet trips (placebo: 0.21), and 0.88 fewer pads used per day (placebo: 0.73). On the quality-of-life questionnaire (scored 0–100, where higher is better), the Sativex group's score increased by an average of 14.21 points versus 9.58 points for the placebo group. On the 0–10 overall bladder condition scale (where lower is better), the Sativex group reported a reduction of 2.3 points compared with 0.9 points in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01599234 · results posted 16 August 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 337 people with muscle spasticity (stiffness or tightness, often related to a neurological condition) — 167 received a treatment called Sativex (a cannabis-based mouth spray) and 170 received a placebo (a dummy spray with no active ingredient). The main thing being measured was how much participants' self-rated spasticity changed over the course of the trial, using a simple 0–10 scale where 0 meant no spasticity and 10 meant the worst possible. A number of secondary measurements were also taken, including muscle stiffness assessed by a clinician, sleep disruption, walking speed, and how many participants experienced any adverse events (unwanted health occurrences) during the study. The reported data shows that, for the main outcome, spasticity scores dropped by an average of 1.22 points in the Sativex group and 0.91 points in the placebo group (both from their starting scores). For the secondary outcomes, 51 people in the Sativex group and 42 in the placebo group reported at least a 30% reduction in their spasticity score. Clinician-measured muscle stiffness scores fell by 3.3 points in the Sativex group and 2.8 points in the placebo group. Sleep disruption scores fell by 0.7 points (Sativex) and 0.6 points (placebo). For the timed 10-metre walk test, the Sativex group's average time decreased by 2.1 seconds, while the placebo group's average time increased by 9.3 seconds — though the data does not explain this difference further. Regarding adverse events, 156 participants in the Sativex group and 132 in the placebo group were reported to have experienced at least one adverse event during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00662649 · results posted 12 July 2012
According to the results reported on ClinicalTrials.gov, this trial involved people with multiple sclerosis and ran in two stages: a core study of 24 months, followed by an extension study out to 60 months. In the core study, 429 people were assigned to fingolimod 1.25 mg, 425 to fingolimod 0.5 mg, and 418 to a placebo (a dummy treatment with no active ingredient). Those who completed the core study could continue into the extension phase, where participants previously on placebo were switched to one of the two fingolimod doses. The trial was primarily measuring how often confirmed relapses (flare-ups of neurological symptoms) occurred, and how long people went without a relapse. It also measured changes in brain scan lesions and brain volume over time. The reported data shows that during the core study (months 0–24), the average number of confirmed relapses per year was 0.064 for the 1.25 mg group, 0.111 for the 0.5 mg group, and around 0.30 for those on placebo. During the extension period (months 24–48), after placebo participants had switched to fingolimod, the reported relapse rates for all groups were lower than in the core study, ranging from 0.074 to 0.164 relapses per year. Looking across the full study period, the reported relapse rates were 0.164 per year for the 1.25 mg group, 0.185 for the 0.5 mg group, and 0.357 for those who had been on placebo before switching. For the question of how many people remained relapse-free by the end of the study, the reported figures were approximately 60% for both fingolimod groups and around 37% for the placebo-then-fingolimod group. The reported data also shows results from brain scans. During the core study, the average number of new or enlarged lesions (bright spots seen on a particular type of brain scan) was 2.14 for the 1.25 mg group, 2.66 for the 0.5 mg group, and 12.83 and 8.12 for the two placebo groups respectively. In the extension period, after the placebo groups had switched to fingolimod, the reported lesion counts for all four groups were broadly similar, ranging from 1.43 to 2.58. Regarding brain volume, all groups showed a small reported decrease over time; during the core study the placebo groups showed slightly larger decreases (around −1.5% and −1.4%) compared to the fingolimod groups (around −1.0%), and during the extension period the reported decreases were smaller across all groups, ranging from approximately −0.78% to −1.10%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00355134 · results posted 26 June 2012
According to the results reported on ClinicalTrials.gov, this trial involved people with multiple sclerosis (MS) and ran in two phases. In the main (core) phase, 370 people received fingolimod at a higher dose (1.25 mg), 358 received it at a lower dose (0.5 mg), and 355 received a placebo (a dummy treatment with no active ingredient) — for a total of 1,083 participants. Some of these participants then continued into an extension phase, where those previously on placebo were switched to one of the two fingolimod doses. The trial was primarily measuring the average number of MS relapses (episodes of new or worsening symptoms) per year in each group over 24 months. The reported data shows that over the core 24-month phase, the estimated average number of relapses per year was 0.203 for the higher-dose group, 0.208 for the lower-dose group, and 0.403 for the placebo group. When relapse rates were calculated across the full study period (including the extension phase), the reported figures were 0.180, 0.192, and 0.363 respectively. The reported data also shows MRI brain scan measurements. Brain volume declined in all three groups over two years, with the placebo group showing a reported change of −1.279% compared to −0.595% (higher dose) and −0.858% (lower dose). The average number of new or newly enlarged areas of inflammation visible on MRI scans was reported as 1.6 (higher dose), 2.3 (lower dose), and 8.9 (placebo) over the first year. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01199861 · results posted 19 June 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 138 people in total — 95 received fingolimod (a medicine used for multiple sclerosis) and 43 received a placebo (an inactive dummy treatment). The trial was measuring how well participants' immune systems responded to two common vaccines — a seasonal flu vaccine and a tetanus booster shot — while taking fingolimod or placebo. Researchers tracked whether participants' blood showed a meaningful rise in antibody levels (the body's protective response) at three and six weeks after each vaccination. The reported data shows that, for the flu vaccine at three weeks, 53.3% of people in the fingolimod group showed an immune response, compared with 83.7% in the placebo group. At six weeks, those figures were 43.2% for fingolimod and 74.4% for placebo. For the tetanus booster, the reported response rates at three weeks were 40.0% (fingolimod) versus 60.5% (placebo), and at six weeks, 37.5% versus 48.8%. The trial also measured how much antibody levels changed from before to after vaccination for each of the three flu strains individually — the reported ratios varied by strain, but in most cases the placebo group showed numerically higher increases than the fingolimod group at both time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00789828 · results posted 1 May 2012
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called everolimus in people with a condition called tuberous sclerosis complex, specifically examining its effect on brain growths known as subependymal giant cell astrocytomas (SEGAs — a type of slow-growing tumour that can form in the brain). The trial had two phases: a core period of 48 weeks where 78 people received everolimus and 39 received a placebo (a dummy treatment with no active ingredient), followed by an open-label extension period of up to four years where 111 people received everolimus. The trial's main goal was to measure how many participants had their SEGA growths shrink by at least half, confirmed by brain scans reviewed by an independent panel of radiologists. The reported data shows that during the core 48-week period, 34.6% of participants in the everolimus group met the criteria for a SEGA response (meaning their growths shrank by at least half and met other scan-based criteria), compared with 0.0% in the placebo group. During the longer extension period, the reported response rate rose to 57.7% among everolimus participants. The reported data also shows changes in seizure frequency (measured by brain-wave monitoring over 24 hours): the everolimus group in the core period showed an average change of −1.24 seizures per 24 hours from their starting point, compared with −0.24 in the placebo group; in the extension period, the reported average change was −6.07. For several other measures — including how long responses lasted and time to worsening — the data was not reported as a single median figure, either because too few events occurred or the milestone was not reached during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
Read the full trial page · View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00649792 · results posted 27 February 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 214 people with multiple sclerosis, all of whom received a medication called Fampridine-SR (a slow-release form of fampridine). There was no comparison or placebo group — everyone in the trial took the same treatment. Of the 214 who started, 146 completed the trial and 68 did not finish. The trial was measuring adverse events (unexpected or unwanted health changes that occurred during treatment) as its main focus, alongside several measures of walking speed and how participants and clinicians felt about any changes over time. The reported data shows that out of 214 participants, 205 experienced at least one treatment-emergent adverse event — meaning an unwanted health change that appeared or got worse after starting the medication. The data also reported 46 serious adverse events, 29 discontinuations due to adverse events, and 1 death, though the trial data does not provide further detail on these figures in the structured results. For the walking test (a timed 25-foot walk), the reported data shows a series of speed measurements across different time points ranging from about 1.85 to 2.60 feet per second, though the specific time points for each measurement were not labelled in the submitted data. Participant satisfaction ratings (on a 1–7 scale, where higher means more satisfied) were generally reported in the range of 4.67 to 5.50 across time points. Clinician impressions (also on a 1–7 scale, where lower numbers indicate more improvement) were reported mostly in the range of 2.50 to 3.96. The reported data also includes a disability scale score (rated 0–10, where higher means greater disability) recorded at two time points: 5.64 and 5.86. It is important to note that because this trial had no comparison group, the reported numbers reflect what was observed in participants taking Fampridine-SR only, and no direct comparison to a placebo or other treatment was made within this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00755807 · results posted 9 December 2011
According to the results reported on ClinicalTrials.gov, this trial looked at duloxetine (a medication) compared to a placebo (a dummy pill with no active ingredient) in people with pain related to multiple sclerosis. A total of 118 people were assigned to duloxetine and 121 to placebo during the first six-week phase. After that, those who completed the first phase moved into an open-label extension phase (where everyone knew they were taking the active medication). The trial was primarily measuring changes in daily pain scores over six weeks, using an 11-point scale where 0 means no pain and 10 means the worst possible pain. The reported data shows that, on average, pain scores in the duloxetine group fell by 1.83 points from their starting level by week six, compared to a fall of 1.07 points in the placebo group. These are adjusted average figures. For the secondary measures, the reported data shows that 47 participants in the duloxetine group and 32 in the placebo group achieved at least a 30% reduction in pain, while 26 in the duloxetine group and 19 in the placebo group achieved at least a 50% reduction. On a 7-point scale where patients rated how much better or worse they felt overall (1 = very much better, 7 = very much worse), the duloxetine group averaged 3.27 and the placebo group averaged 3.48 at six weeks. Various other measures of pain severity, how much pain interfered with daily life, and quality of life were also reported, with the duloxetine group generally showing slightly larger numerical changes from baseline than the placebo group across those scales. The reported data also shows changes in quality-of-life scores (using a 54-item multiple sclerosis quality-of-life tool, where higher scores indicate better health), with the duloxetine group reporting a change of 6.11 in physical health composite and 6.54 in mental health composite scores, compared to 5.12 and 6.51 respectively in the placebo group. A clinician-rated severity scale also showed a slightly larger reduction in the duloxetine group (−0.67) than the placebo group (−0.44). These are the numbers as submitted; what they mean in a broader clinical context was not detailed in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00681538 · results posted 7 December 2011
According to the results reported on ClinicalTrials.gov, this trial involved people with spasticity (muscle stiffness and spasms, often associated with conditions like multiple sclerosis). The trial had two phases. In the first phase, 572 participants tried the active treatment (Sativex, a cannabis-based mouth spray) for four weeks in an open way — meaning everyone knew what they were receiving. Of those, 538 completed this phase. People who showed a meaningful response during that first phase were then invited into the second phase: 124 were assigned to continue with Sativex and 117 received a placebo (a dummy spray with no active ingredient) for 12 weeks, without knowing which one they had. The trial was primarily measuring changes in self-reported spasticity using a 0–10 rating scale, where 0 meant no spasticity and 10 meant the worst possible spasticity. The reported data shows that at the end of the 12-week double-blind phase, the Sativex group had an average spasticity score of 3.68 points, compared to 4.56 points in the placebo group. For a secondary measure looking at how many participants achieved at least a 30% reduction in their spasticity score, the reported data shows 92 out of 124 in the Sativex group compared to 60 out of 117 in the placebo group. For a 50% or greater reduction, the figures were 56 (Sativex) versus 39 (placebo). The reported data also shows the Sativex group had an average of 5.56 spasms per day compared to 7.70 in the placebo group, and a sleep disruption score of 1.71 versus 2.65. Two further measures — one assessing muscle tone assessed by a clinician (Modified Ashworth Scale) and one assessing limb movement ability (Motricity Index) — were also recorded, though the differences between groups on those scales appeared small and the data as reported does not indicate how meaningful those changes were considered to be. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00828204 · results posted 9 August 2011
According to the results reported on ClinicalTrials.gov, this trial looked at a single-use autoinjector device designed to deliver Avonex (a medicine used for multiple sclerosis). The trial was split into two main groups: an "Initial Subset" of 21 participants who joined before the study was paused, and a "Main Subset" of 74 participants who joined after the study restarted. A separate extension phase also took place, in which 64 participants from the Main Subset continued. The trial measured whether participants could successfully use the autoinjector on their own, as well as things like how easy the device was to use, what the injection site looked like afterwards, and how participants rated the training materials provided. The reported data shows that, in the Main Subset, 89% of participants were recorded as having completed every step of the injection process — setting up the device, giving themselves the injection, and capping and disposing of it — without any failures. For the Initial Subset, 14 out of 21 participants reported being satisfied with the autoinjector when asked directly. When a clinician checked the injection site after use, the reported data shows that 65% of Main Subset participants had no redness, swelling, tenderness, or unusual warmth at the site (with this figure varying across different time points). Participants rated the ease of use on a scale from 0 (extremely difficult) to 10 (extremely easy); the Main Subset reported average scores ranging from 8.1 to 9.3 across the different injection sessions, while the Initial Subset reported average scores ranging from 5.9 to 7.4. Regarding the printed and DVD training materials, between 88% and 93% of Main Subset participants rated them as "very effective," depending on the specific material assessed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00947752 · results posted 9 June 2011
According to the results reported on ClinicalTrials.gov, this trial involved 147 participants and compared two different formulations of a medicine called Glatiramer Acetate — both containing the same dose (20mg), but delivered in different injection volumes: a larger 1.0ml injection and a smaller 0.5ml injection. The trial used a "crossover" design, meaning participants tried both formulations at different points during the study. The main thing being measured was how much pain people felt immediately after each injection, rated on a simple scale from 0 (no pain at all) to 100 (the worst pain imaginable). The reported data shows that, for pain felt immediately after the injection, participants scored the larger 1.0ml injection at an average of 11.89 out of 100, while the smaller 0.5ml injection was scored at an average of 8.64 out of 100. The trial also measured pain felt within 5 minutes after the injection as a secondary measure. The reported data shows the 1.0ml injection scored an average of 17.19 out of 100 for this timepoint, compared to 11.85 out of 100 for the 0.5ml injection. Both scores across both timepoints were toward the lower end of the pain scale for all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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NCT00340834 · results posted 16 May 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,292 participants across three groups during its main (core) phase: 426 people received fingolimod at a higher dose (1.25 mg), 431 received fingolimod at a lower dose (0.5 mg), and 435 received an existing multiple sclerosis injection treatment called interferon β-1a. The trial was primarily measuring how often participants experienced relapses — that is, episodes where MS symptoms appeared or worsened — over the course of the study. An extension phase followed, during which some participants who had been on interferon β-1a were switched to one of the fingolimod doses. The reported data shows that during the core phase, the estimated number of relapses per year was 0.203 in the higher-dose fingolimod group, 0.161 in the lower-dose fingolimod group, and 0.331 in the interferon β-1a group. For brain scan findings (MRI scans looking for new or enlarged areas of inflammation, called T2 lesions), the reported average number of new lesions was 1.6 in each fingolimod group and 2.6 in the interferon group. Regarding disability progression — measured on a standard scale where scores run from 0 (no disability) to 10 — the percentage of participants who did not show worsening over at least three months was reported as 93.3% in the higher-dose fingolimod group, 94.1% in the lower-dose fingolimod group, and 92.1% in the interferon group. During the longer extension phase, some additional relapse rate and lesion count figures were also reported, though several of those data points were listed as not available in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00483652 · results posted 14 April 2011
According to the results reported on ClinicalTrials.gov, this trial enrolled 239 people with multiple sclerosis — 120 received a twice-daily tablet called Fampridine-SR (10 mg) and 119 received a placebo (a dummy tablet with no active ingredient). The trial was measuring whether Fampridine-SR made a difference to walking speed and leg muscle strength compared to the placebo. The main thing being measured was how many people in each group were classed as "walking responders" — meaning their timed walk over 25 feet was consistently faster during the treatment period than before it. The reported data shows that 51 out of 120 people in the Fampridine-SR group were classed as walking responders, compared to 11 out of 119 people in the placebo group. For the secondary measure — leg muscle strength, rated on a scale from 0 (no movement at all) to 5 (normal strength) — the reported data shows an average improvement of 0.09 units in the Fampridine-SR group and 0.04 units in the placebo group. Both changes were very small relative to the scale used. It is worth noting that the trial followed participants through a double-blind treatment period (where neither participants nor researchers knew who was taking which tablet) and a short follow-up period afterwards. The reported data shows that the vast majority of participants in both groups completed both periods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00185211 · results posted 30 November 2010
According to the results reported on ClinicalTrials.gov, this trial followed on from an earlier placebo-controlled study and involved people who had experienced a first episode suggesting possible multiple sclerosis (MS). One group had received the active treatment, interferon beta-1b, from the start of the earlier study (292 people), while the other group had initially received a placebo (176 people). The follow-up study tracked 261 and 157 people from these two groups respectively over up to five years, measuring how many went on to develop clinically confirmed MS, whether their level of disability changed over time, and how their quality of life was affected. The reported data shows that, at the five-year mark, an estimated 46.2% of those who had been on the active treatment from the beginning had developed clinically definite MS, compared with 57.3% of those who had started on placebo. For worsening disability (measured on a standard MS disability scale running from 0 to 10), the reported figures at five years were 24.9% in the initial treatment group and 28.9% in the initial placebo group. The reported data also shows that the initial treatment group took a median of around 9.4 months to meet a broader MS diagnosis criteria, compared with 6 months in the placebo group. The average number of relapses per person per year was reported as approximately 0.21 in the initial treatment group and 0.27 in the initial placebo group. For quality of life (scored on a scale of 0–148, where higher means better self-reported physical health), both groups scored 125 at the five-year point — no difference was reported between them on this measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00441103 · results posted 5 July 2010
According to the results reported on ClinicalTrials.gov, this trial enrolled 180 people in total — 120 in the Rebif® New Formulation (RNF, a form of interferon beta-1a) group and 60 in the placebo group. Of those, 109 and 56 participants respectively completed the study. The trial was measuring brain lesion activity using MRI (brain scans) at set time points, as well as tracking unwanted medical events (called adverse events) that occurred during the study. The trial had two main stages: a blinded period up to week 16, and a follow-on period up to week 40 where those who had been on placebo were switched to RNF. The reported data shows that at week 16, participants in the RNF group had an average of 0.9 combined unique active brain lesions on their MRI scans, compared to 3.0 in the placebo group. For a secondary measure looking only at the group that started on placebo and then switched to RNF, the reported average number of lesions per scan was 2.31 during the placebo period and 0.65 after switching to RNF. A separate secondary MRI measure reported 0.62 lesions on average in the RNF group and 1.27 in the placebo group. Regarding adverse events (unexpected or unwanted medical occurrences), the reported data shows that 100 participants in the RNF group and 39 in the placebo/RNF group experienced an adverse event during the double-blind period, and 72 and 43 respectively during the follow-on period. Serious adverse events were reported for 4 participants in the RNF group and 3 in the placebo/RNF group, though further detail on those events was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00306592 · results posted 26 January 2010
According to the results reported on ClinicalTrials.gov, this trial (NCT00306592) enrolled 404 participants who received the study drug natalizumab (given as a monthly intravenous drip at a dose of 300 mg). The trial was primarily measuring safety-related information: specifically, how many participants experienced adverse events (unexpected or unwanted medical occurrences) and serious adverse events (those involving hospitalisation, life-threatening situations, lasting disability, or death), as well as allergic-type reactions to the infusion and whether participants developed antibodies (proteins the body can produce in response to a foreign substance) against the drug. Data from a related companion study (NCT00297232, which enrolled 690 participants) was also included in some of the reporting. The reported data shows that, across both studies combined, out of 1,004 participants who received at least one dose of the drug, 826 experienced at least one adverse event of any kind. Of those, 487 had adverse events that were considered related to the treatment, 66 experienced a serious adverse event, and 161 had a serious adverse event considered related to the treatment. Additionally, 61 participants experienced a life-threatening event, 5 died, and 24 experienced a serious adverse event leading to hospitalisation. The reported data also shows that 8 participants experienced a hypersensitivity (allergic-type) reaction during or shortly after their infusion. Regarding antibodies to the drug, the reported data shows that out of 1,004 participants tested, 15 had a positive antibody result at only one point in time with no follow-up test available, 8 had a result that was positive once but then returned to negative, and 16 had a persistently positive result across at least two tests. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00050778 · results posted 25 August 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 334 people with multiple sclerosis (MS) across three groups: 111 received a medicine called interferon beta-1a (an existing MS treatment used for comparison), 113 received a lower dose of alemtuzumab (12 mg), and 110 received a higher dose of alemtuzumab (24 mg). The trial ran for three years and measured two main things: how often participants experienced relapses (episodes of worsening MS symptoms), and how many developed a sustained worsening of their disability over time, as measured by a standard MS disability scale where a higher score means greater disability. The reported data shows that for the disability worsening measure, the estimated probability of experiencing sustained disability accumulation was 0.27 (roughly 27 in 100) in the interferon beta-1a group, compared with 0.08 and 0.09 in the two alemtuzumab groups. For relapses, the reported average number of relapses per person per year was 0.37 in the interferon beta-1a group, 0.12 in the lower-dose alemtuzumab group, and 0.09 in the higher-dose alemtuzumab group. The reported data also shows that the estimated proportion of participants who remained relapse-free over three years was 0.50 (about 50 in 100) in the interferon beta-1a group, compared with 0.76 and 0.84 in the two alemtuzumab groups. On the brain scan measures reported as secondary outcomes, the interferon beta-1a group showed an average 23.4% increase in the volume of lesions (areas of MS damage visible on MRI) over three years, while the alemtuzumab groups showed decreases of around 11.4% and 8.9% respectively. Brain volume (which tends to decrease in MS) showed an average reduction of 1.9% in the interferon beta-1a group compared with reductions of 0.8% and 0.4% in the alemtuzumab groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00459667 · results posted 17 August 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 1,420 participants across three groups, all of whom were receiving a medicine called interferon beta-1b (IFNB-1b). Two groups received the drug as a new treatment (one at a higher dose of 500 micrograms and one at a lower dose of 250 micrograms), while a third, smaller group of 181 people had already been taking the 250 microgram dose before the study began. The trial was primarily measuring how often participants experienced flu-like symptoms, reactions at the injection site, changes in liver enzyme levels in the blood, and changes in blood cell counts. A secondary measure looked at how many participants developed antibodies — proteins the body can produce in response to the medicine — that might reduce how the drug behaves in the body. The reported data shows that flu-like symptoms were recorded in 17.4% of the higher-dose group, 15.8% of the new lower-dose group, and 31.1% of those who had already been on the lower dose. Injection-site reactions were reported in 31.7%, 26.2%, and 31.7% of participants in those same three groups respectively. Liver enzyme changes were reported across several measurement points, with figures ranging from roughly 1.2% to 4.4% depending on the group and the specific measurement taken. Blood count changes were generally low across all groups, with most figures falling below 2.2%. For the secondary measure, the reported data shows that antibodies against the medicine were detected in 26.6% of the higher-dose group, 21.7% of the new lower-dose group, and 16.6% of those already on the lower dose, with smaller percentages in each group showing antibodies at higher levels. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00235989 · results posted 3 July 2009
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called interferon beta-1b (IFNB-1b), which was given by injection at different doses. The trial had two phases: a core treatment period and a longer extension period. In the core period, 36 participants received the 250 microgram dose and 27 received the 500 microgram dose. In the extension period, a further 61 participants were spread across four groups that either stayed on the same dose or switched between the two dose levels. The trial was primarily measuring how participants responded to the medicine in terms of side effects — things like flu-like symptoms, fever, muscle aches, injection site reactions, fatigue, headache, and changes in liver or bone marrow function as measured by blood tests. The reported data shows that, for the primary measure of side effects during the extension period, the numbers of participants experiencing these reactions varied by group. Across the four extension groups (which ranged from 6 to 20 people each), the number of participants with recorded side effects of any grade ranged from 1 to 7 people per group. More participants in the group that moved from 250 to 500 micrograms (7 people) had recorded side effects compared to the other groups. Lower grades of side effects (meaning no action or only a possible dose adjustment was needed) were more commonly recorded than the most serious grade. The reported data also shows results for a secondary measure — the number of participants who developed so-called "neutralising antibodies" (proteins the body can produce that may affect how a medicine works) during the extension period. Across the four extension groups, between 0 and 5 participants per group had detectable neutralising antibody levels above certain cut-off points at various time points during the study. It is worth noting that the extension groups were small, and the data as reported does not include results from the core treatment period groups for these outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.