Reported trial results for Peripheral Neuropathy
Every Peripheral Neuropathy 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.
88 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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NCT03439046 · results posted 10 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT03439046) enrolled 287 participants in its main ("core") phase, where they received a combination of two medicines called ribociclib and letrozole. A smaller group of 21 participants then entered an extension phase and received a different combination — alpelisib and fulvestrant. The trial was primarily measuring how long participants went without their cancer growing or spreading (called "progression-free survival"), and also tracked changes in tumour-related genetic markers found in blood samples over time. The reported data shows that progression-free survival — the time before disease progression or death — varied depending on how participants' blood-based genetic markers changed during early treatment. For example, participants whose markers stayed at a baseline ("persistent wild type") had a reported median progression-free survival of around 55.8 months, while other subgroups ranged from approximately 10.2 to 22.4 months. The number of participants who experienced a progression event in each of these subgroups ranged from 6 to 31. The reported data also shows changes in a specific genetic signal in the blood (called "variant allele frequency") ranging from a 47% decrease to a 100% decrease from the starting point, depending on the subgroup. In the extension phase, 3 out of 21 participants were reported to have had a partial response — meaning their tumour size decreased by at least 30% as measured by standard imaging criteria. A secondary measure, a blood marker called Thymidine Kinase 1, was reported to have changed from the starting point by amounts ranging from a decrease of about 73% to an increase of about 57%, depending on the subgroup 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.
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NCT04868123 · results posted 8 July 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT04868123) enrolled 36 people in total — 12 in each of three groups: Mindfulness Meditation, Transcutaneous Nerve Stimulation (TENS, a device that delivers mild electrical pulses through the skin), and Usual Care (the standard treatment people would normally receive). The trial ran for 7 weeks and was measuring two main things: how much pain people felt (pain intensity) and how much that pain got in the way of daily life (pain interference). It also looked at how people walked — including their speed, step length, stride width, and the number of steps taken per minute. Not everyone finished the study: 10 of 12 completed the Mindfulness group, 8 of 12 completed the TENS group, and 11 of 12 completed the Usual Care group. The reported data shows that for pain intensity (scored 0–10, where a lower number means less pain), the average score change from the start to 7 weeks was −0.8 in the Mindfulness group (a small decrease), +0.3 in the TENS group (a small increase), and −0.5 in the Usual Care group (a small decrease). For pain interference, the reported changes were +0.1 (Mindfulness), +0.2 (TENS), and −0.1 (Usual Care) — all very small shifts on the same 0–10 scale. For the walking measures, the reported average changes in walking speed were +2.7 metres per second (Mindfulness), +0.9 (TENS), and +2.2 (Usual Care). Step length changes were +0.6 metres (Mindfulness), +1.4 (TENS), and −0.3 (Usual Care). Stride width changes were +1.1 metres (Mindfulness), −0.2 (TENS), and 0 (Usual Care). Cadence (steps per minute) changed by +2.8 (Mindfulness), −1.9 (TENS), and +1.9 (Usual Care). It is worth noting that this was a small study with only 12 people per group, which means the numbers above should be interpreted with caution. The reported data shows changes across all three groups over the 7-week period, but no conclusions about whether any one approach is better than another 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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NCT03939481 · results posted 8 June 2026
According to the results reported on ClinicalTrials.gov, this observational study enrolled 1,336 participants who were already receiving chemotherapy as part of their usual care. The study was not testing a new treatment — instead, it was tracking and measuring a common side effect of chemotherapy called peripheral neuropathy (nerve damage that can cause tingling, numbness, or pain, usually in the hands and feet). Participants completed questionnaires and assessments, and 1,114 people completed the study, while 222 did not. The reported data shows that the main thing being measured was how many participants developed peripheral neuropathy during the study, defined as a meaningful increase in nerve-related symptoms on a standard questionnaire scale (called the CIPN-20) compared to their starting point, measured up to 24 weeks. According to the results reported on ClinicalTrials.gov, 792 out of the 1,336 participants who started the study showed this level of increase in peripheral neuropathy symptoms. The study also set out to measure several other things, including changes to treatment doses, quality of life, and patient-reported symptom burden — however, the results data for all of those secondary outcomes 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 ↗
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NCT07360730 · results posted 30 March 2026
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 participants, all of whom completed the study with no drop-outs. Every participant received the HPTC Nerve Wrap, a device applied around a damaged nerve. The trial was measuring how well the nerves recovered — both in terms of movement (motor recovery) and feeling (sensory recovery) — as well as pain levels and how well participants were able to use their arms or legs in daily life. The reported data shows that, for movement recovery, 34 out of 40 participants reached a level where the affected muscles could move against gravity, which was the defined threshold for successful motor recovery. For sensation, two different tests were used. A touch-sensitivity test (Semmes-Weinstein monofilament testing) found that 27 out of 40 participants showed sensory recovery at two months after surgery. A second sensation test — measuring the smallest gap between two points a person could feel as separate — returned an average result of 8.6 millimetres across the group. For pain (rated on a 0–10 scale where 10 is the worst imaginable), the reported data shows three separate measurements of 6.8, 5.0, and 2.4, though the time points for each measurement were not specified in the submitted data. For arm function (scored 0–100, where higher means more difficulty), scores of 58.2 and 31.4 were reported at two time points. For leg function (scored 0–80, where higher means better function), scores of 53.7 and 68.9 were reported at two time points. The specific timing of these follow-up measurements was 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT05005845 · results posted 17 February 2026
According to the results reported on ClinicalTrials.gov, this trial involved 199 people in total, split across three groups: 67 people used a vehicle gel (a gel with no active ingredient, sometimes called a placebo), 66 used a 0.5% strength gel called NFX-179, and 66 used a 1.5% strength gel of NFX-179. The trial was looking at skin tumours called cutaneous neurofibromas (small lumps that grow under or on the skin, commonly seen in a condition called neurofibromatosis type 1). The main things being measured were how many participants experienced unwanted medical events after starting treatment, and whether the size of those skin lumps reduced by at least half in enough of the treated spots after six months. Not everyone finished the trial — 57 people completed it in the vehicle group, 49 in the 0.5% group, and 40 in the 1.5% group. The reported data shows that when it came to unwanted medical events (called treatment-emergent adverse events — meaning any medical occurrence that happened or got worse after the first dose), 35 out of 67 people in the vehicle group, 36 out of 66 in the 0.5% group, and 49 out of 66 in the 1.5% group experienced at least one such event. For the main measure of tumour size reduction, the reported data shows that 24.1% of people in the vehicle group, 34.6% in the 0.5% group, and 44.2% in the 1.5% group met the target of having at least half of their monitored lumps shrink in volume by 50% or more. On the secondary measures, the average reduction in tumour volume from the start of the trial was reported as 14.7% for the vehicle group, 26.7% for the 0.5% group, and 28.6% for the 1.5% group. Doctors' severity ratings and participants' own severity ratings of the lumps also showed reductions across all three groups by day 182, with the numbers varying between groups as detailed in the full 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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NCT05054725 · results posted 6 January 2026
According to the results reported on ClinicalTrials.gov, this trial (NCT05054725) enrolled 47 people with an advanced or spreading form of lung cancer (non-small cell lung cancer) that carried a specific genetic change called KRASG12C. Participants had already tried standard treatments that had stopped working. The trial tested a combination of two medicines — RMC-4630 and sotorasib — at two different dose levels. The main thing the trial was measuring was the "objective response rate," meaning the proportion of participants whose tumours shrank or disappeared (confirmed by scans taken at least 28 days apart) — often called a complete or partial response. The trial also tracked changes in vital signs, blood test results, heart trace readings (ECGs), and the levels of both medicines in participants' blood over time. The reported data shows that 4 people were in the lower-dose group and 43 in the higher-dose group. For the primary measure — how many participants had a confirmed tumour response — the reported figures were 0 out of 4 in the lower-dose group, and 11 out of 43 in the higher-dose group. For the secondary monitoring measures: no participants in either group showed clinically significant changes in vital signs or ECGs. For laboratory (blood/urine) test changes, the reported data shows between 0 and 2 participants affected in the lower-dose group and between 2 and 5 in the higher-dose group across various categories measured. Blood levels of both medicines were also measured at different time points; the reported concentration figures varied across dose groups and time points, but a plain breakdown of each individual reading was not fully labelled in the submitted data, so a detailed description of each specific time point cannot be provided 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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NCT05554146 · results posted 13 November 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05554146) enrolled 34 people in total, split across four groups. Each group received a discount coupon for a different cannabis product: a placebo (no active cannabis), a high-THC product, a product with equal amounts of THC and CBD, or a high-CBD product. The trial ran for 14 weeks and measured self-reported pain levels, certain markers in the blood related to inflammation, and how well participants stuck to their HIV medication (antiretroviral therapy). Between 30 and 34 participants completed the study, with the high-THC group having the most drop-outs (2 out of 8). The reported data shows that for pain — rated on a 0-to-10 scale where 10 is the worst imaginable pain — average scores at the start of the study ranged from about 6.4 to 8.0 across the four groups. By the end of 14 weeks, those averages had shifted to roughly 5.2 to 7.6. Negative changes would indicate lower pain scores compared to the start, and each group showed some degree of downward movement in their average score over time. For the blood inflammation markers (measured using a technical scale called NPX), the changes from start to finish were small in all four groups, with some groups showing slight increases and others slight decreases depending on the specific marker measured. For medication adherence — scored as a percentage of doses taken — the reported changes from start to finish were modest, ranging from a drop of 1 percentage point in the placebo group to a rise of 2 percentage points in the equal THC/CBD 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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NCT03962543 · results posted 7 August 2025
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called mirdametinib (also known as PD-0325901) in people with neurofibromatosis type 1 (NF1) who had tumours called plexiform neurofibromas. A total of 114 participants were enrolled — 56 children and 58 adults. The trial's main goal was to measure how many participants had their tumour shrink by at least 20% in volume by the end of the treatment period (up to 24 cycles), as confirmed by independent review of MRI scans. The reported data shows that, among the children's group, approximately 51.8% of participants met the criteria for a confirmed tumour response (meaning their tumour shrank by at least 20%). In the adult group, approximately 41.4% of participants met that same threshold. For the secondary measure looking at how long that response lasted (called "duration of response"), no numerical figures were reported in the data — this information was not available at the time of reporting. All participants in both groups — 100% — were recorded as having experienced at least one treatment-emergent adverse event (that is, an unwanted health event that occurred during or after treatment), though the data as submitted does not break down the nature or severity of those events in detail here. The reported data also shows some secondary quality-of-life and pain measures. On quality-of-life questionnaires, small positive changes from the starting point were reported for both children and adults at the mid-point of treatment. On pain scales, small reductions in reported pain scores were noted — for example, a change of around −0.79 points (out of 10) for children and −1.33 points for adults on one pain scale. These are the numbers as submitted and do not indicate whether the changes were considered meaningful. 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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NCT05660538 · results posted 1 July 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT05660538) enrolled 194 people in total across four groups: 55 received pregabalin (an existing pain medicine used here for comparison), 28 received a low dose of suzetrigine, 55 received a mid dose of suzetrigine, and 56 received a high dose of suzetrigine. The trial was measuring changes in pain levels over time using an 11-point scale (where 0 means no pain and 10 means the worst imaginable pain), as well as how pain affected sleep, and how participants felt their overall condition had changed. The reported data shows that for the main measure — the change in average daily pain scores from the start of the trial to the end — all four groups showed a reduction in their scores. The pregabalin group's average score dropped by 2.09 points, the low-dose suzetrigine group by 2.18 points, the mid-dose group by 2.11 points, and the high-dose group by 2.26 points. For the sleep interference scale (also 0–10, where higher means more disruption), the reported reductions ranged from 2.15 to 2.44 points across the groups. When looking at the share of participants whose pain scores dropped by at least 30%, the reported figures were 44.9% in the pregabalin group, 70.8% in the low-dose suzetrigine group, 46.0% in the mid-dose group, and 48.0% in the high-dose group. For a 50% reduction, the figures were 22.4%, 41.7%, 32.0%, and 34.0% respectively. For a 70% reduction, the figures were 10.2%, 8.3%, 22.0%, and 22.0%. When participants were asked to rate their overall change in condition, the proportion who said they felt "much improved" or "very much improved" ranged from about 47% to 52% 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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NCT05786612 · results posted 5 March 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 102 people in total — 51 in each group. Participants were assigned to have their wounds dressed with either a combination of Mepilex Border and Aquacel Extra Hydrofiber dressings, or Biatain® Silicone dressings. The trial ran for four weeks and was measuring how much wounds shrank in size, as well as how much the dressings cost over that period. The reported data shows that, when wound size at the start of the trial was compared to wound size at four weeks, the Mepilex Border with Aquacel Extra Hydrofiber group had an average wound area reduction of 43%, while the Biatain® Silicone group had an average wound area reduction of 54.3%. These figures simply describe how much smaller wounds were on average by the end of the four weeks — a positive number means the wound got smaller, while a negative number would have meant it grew (no negative values were reported here). For the secondary measure, the reported data shows that the average dressing cost over the four weeks was £21.40 for the Mepilex Border with Aquacel Extra Hydrofiber group, and £14.30 for the Biatain® Silicone group. These costs were based on the number of dressings used multiplied by the listed price of each product at the time the trial ended. 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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NCT04833777 · results posted 10 February 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 140 people in total — 68 in the lidocaine group and 72 in the bupivacaine group. One person in the lidocaine group did not complete the study, leaving 67 and 72 participants respectively for the final analysis. The trial was comparing two local anaesthetic medicines (lidocaine and bupivacaine) by tracking how much pain participants reported after their operation at multiple points in time following surgery. The reported data shows that pain was measured using a scale from 0 to 10, where 0 means no pain at all and 10 means the worst pain imaginable. Across six recorded time points after the operation, the lidocaine group reported average pain scores of 1.16, 2.16, 3.19, 3.87, 3.81, and 3.22. The bupivacaine group reported average scores of 0.92, 1.54, 2.29, 2.92, 3.38, and 3.38 at those same time points. The reported data does not specify exactly when each of these measurements was taken, so the precise timing of each reading cannot be confirmed from the information submitted. No 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.
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NCT05246670 · results posted 24 January 2025
According to the results reported on ClinicalTrials.gov, this trial enrolled 88 people in total across four groups: 29 received a lower dose of a supplement called PEA (palmitoylethanolamide), 30 received a higher dose of PEA, and 29 received a placebo (an inactive treatment), split across two placebo groups. The trial was measuring whether PEA had any effect on nerve-related symptoms caused by chemotherapy — a condition known as chemotherapy-induced peripheral neuropathy — using a 20-question survey called the CIPN20. On that survey, scores range from 20 to 80, where lower scores mean fewer or less bothersome symptoms. The trial ran for 8 weeks, and most participants completed it (25, 27, 13, and 14 people respectively finished in each group). The reported data shows that, from the start of the trial to the end of 8 weeks, all three groups recorded a drop in their CIPN20 scores (meaning reported symptoms went down on average across the board). The lower-dose PEA group had an average decrease of 4.2 points, the higher-dose PEA group had an average decrease of 6.3 points, and the combined placebo group had an average decrease of 6.4 points. For the secondary outcome looking at self-rated quality of life (on a 0–10 scale where 10 is best), the reported data shows the lower-dose and higher-dose PEA groups each recorded an average increase of 0.6 points, while the combined placebo group recorded an average decrease of 0.6 points. Regarding serious unwanted events (graded as severe or higher), 2 participants in the lower-dose PEA group and 2 participants in the combined placebo group experienced at least one such event, while none were reported in the higher-dose PEA group. The remaining pre-specified outcomes listed in the trial 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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NCT04709419 · results posted 15 January 2025
According to the results reported on ClinicalTrials.gov, this trial (NCT04709419) was set up to compare two types of socks — a "Celliant" sock and a standard control sock — in people with wounds on their feet or legs. The trial aimed to measure three things: changes in the level of oxygen in the tissue around wounds (using a special imaging technique), how many participants achieved complete wound closure, and how many maintained that closure over time. The reported data shows that only one person was enrolled in the Celliant sock group, and no one was enrolled in the control sock group. That single participant did not complete the study. Because of this, no results were collected or reported for any of the three outcome measures — the tissue oxygen levels, wound closure rates, and maintained wound closure figures were all left blank in the submitted data. In plain terms, the trial did not gather enough participants to produce any meaningful numbers on the things it set out to measure. The reasons for this were not explained 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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NCT04136184 · results posted 10 December 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT04136184) enrolled 168 people in total — 24 received a medicine called inotersen and 144 received a medicine called eplontersen. The trial was studying a condition involving nerve damage caused by a protein called TTR, and it measured three main things over roughly 65–66 weeks: changes in nerve impairment (using a scoring system called mNIS+7, where a higher score means worse nerve function), changes in quality of life (using a questionnaire called Norfolk QoL-DN, where a higher score means poorer quality of life), and changes in the level of TTR protein in the blood. Notably, very few participants formally "completed" the study as defined by the trial record (1 in the inotersen group and 22 in the eplontersen group), though the majority contributed data that was analysed. The eplontersen results were compared against an external placebo group (people from a separate, earlier study who received a dummy treatment), not against the inotersen group. The reported data shows the following numbers for the eplontersen group compared to the external placebo group. On the nerve impairment score (mNIS+7) at around week 66, the eplontersen group's score changed by approximately +0.30 points from their starting point (meaning very little change), while the external placebo group's score rose by approximately +25.06 points (meaning noticeably worse nerve function). At the midpoint (around week 35), the reported figures were +0.68 for eplontersen and +10.03 for the placebo group. On the quality-of-life questionnaire at week 66, the eplontersen group's score changed by approximately −5.50 points (a small movement toward better quality of life on the scale), while the external placebo group's score rose by approximately +14.24 points (a movement toward worse quality of life on the scale); at week 35 those figures were −3.63 and +8.19 respectively. For the TTR protein level in the blood, the eplontersen group showed a reported reduction of about 81.6% at week 65, compared with approximately 11.2% in the external placebo group; similar figures (about 81.1% versus 14.5%) were reported at week 35. No outcome data for the inotersen group was included in the reported results, as the trial was not designed to compare the two medicines directly. 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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NCT05139680 · results posted 19 September 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05139680) enrolled 10 participants, all of whom received the medicine tafamidis. All 10 participants completed the study — none dropped out. The trial was looking at whether participants' neurological (nerve-related) function changed over time, comparing a period of at least six months before starting treatment to a period of at least six months after starting treatment. Three different tools were used to measure this: one that assessed muscle weakness (the NIS subscale), one that assessed walking ability (the PND score), and one that assessed muscle strength (the MRC scale). The reported data shows the following when comparing before and after treatment. For the muscle weakness assessment (NIS subscale), out of 10 participants, 2 showed no change, 2 showed an increase in their score (meaning more weakness recorded), and 3 showed a decrease in their score (meaning less weakness recorded) — notably, this adds up to only 7, and results for the remaining participants were not reported in the submitted data. For walking ability (PND score), 6 participants showed no change, 1 showed a higher (worse) score, and 3 showed a lower (better) score. For muscle strength (MRC scale), 8 showed no change, 1 showed a decrease (lower strength recorded), and 1 showed an increase (higher strength recorded). A secondary measure called the modified Body Mass Index (mBMI — a combined score of body weight and a blood protein called albumin) was also tracked; the reported data shows an average value of approximately 1,001 before treatment and approximately 1,071 after treatment. 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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NCT03860935 · results posted 27 June 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT03860935) enrolled 632 people in total — 421 received acoramidis HCl 800 mg and 211 received a placebo (a dummy pill with no active ingredient). The trial was studying a heart condition called transthyretin amyloid cardiomyopathy, and it tracked four things together over 30 months: deaths from any cause, how often participants were hospitalised for heart-related reasons, changes in a heart-stress blood marker (NT-proBNP), and changes in how far participants could walk in six minutes (the "6-minute walk test"). By the end of the study, 331 participants in the acoramidis group and 154 in the placebo group had completed the trial. The reported data shows the main result was calculated using a method that ranks every participant against every other participant across all four of those measures combined, awarding a "win" to whoever fared better overall. The acoramidis group recorded 63.7% of wins compared with 35.9% for the placebo group. Looking at the individual measures reported separately: in the 6-minute walk test, both groups walked less distance by month 30 than at the start — the acoramidis group's distance dropped by an average of about 65 metres, while the placebo group's dropped by about 104 metres. On a heart-failure quality-of-life questionnaire scored from 0 to 100 (higher meaning better), scores fell in both groups — by about 11 points in the acoramidis group and about 21 points in the placebo group. A blood protein called TTR (prealbumin, used as a marker of the condition) rose by an average of 5.78 mg/dL in the acoramidis group and fell by 1.32 mg/dL in the placebo group. For the combined count of deaths, heart transplants, or implantation of a heart-assist device by month 30, 79 participants in the acoramidis group and 52 in the placebo group reached that 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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NCT04001829 · results posted 12 June 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 249 people in total — 126 in Arm A (receiving paclitaxel) and 123 in Arm B (receiving docetaxel). Both paclitaxel and docetaxel belong to a group of chemotherapy medicines called taxanes. The trial was measuring nerve damage in the hands and feet — known as peripheral neuropathy — that can occur as a side effect of these medicines. Participants were also sorted into two groups based on their genetic profile: a "high-risk genotype" group and a "low-risk genotype" group, to see whether a person's genes were linked to how much nerve-related side effects they experienced. The reported data shows that among participants on paclitaxel (Arm A), 47% of those in the high-risk genotype group and 35% of those in the low-risk genotype group experienced moderate-to-severe nerve symptoms (graded 2–4 on a standard medical scale). For docetaxel (Arm B), those figures were 28% (high-risk group) and 19% (low-risk group). When comparing the two treatment arms overall, 44% of paclitaxel participants and 25% of docetaxel participants were reported to have moderate-to-severe nerve symptoms. The reported data also shows that 28% of paclitaxel participants had their dose reduced specifically because of nerve symptoms, compared with 8% in the docetaxel group; and when counting dose reductions for any reason, the figures were 39% and 25% respectively. A separate patient-reported questionnaire (scored 0–44, where higher scores mean fewer symptoms) showed an average worsening of 7.3 points in the high-risk paclitaxel group and 8.1 points in the low-risk paclitaxel group from the start of treatment to the end — both representing a decline, though the data does not allow conclusions about why the groups differed. 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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NCT02313428 · results posted 25 April 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT02313428) compared two approaches to wound care over 16 weeks. Two participants received standard wound care plus a topical oxygen treatment (where oxygen is applied directly to the wound), and two participants received standard wound care alone. Out of the four people who started the trial, only two — one from each group — completed it fully, meaning the numbers involved are very small. The reported data shows that the main thing being measured was how much wounds closed over 16 weeks, recorded in square centimetres. The group receiving topical oxygen treatment alongside standard care showed a reported change in wound size of 3.3 cm², while the standard care only group showed a reported change of 0.00 cm². For the secondary measurements: no amputations (0 participants) were recorded in either group during the trial period. One participant in each group was reported to have experienced an infection-related complication. A quality-of-life survey (the SF-36, which scores from 0 to 100 where a higher score means a more favourable health state) recorded an average score of 38.9 for the topical oxygen group and 51.5 for the standard care only group. The reported data shows that no figures for cost of care were submitted — this outcome was not reported. It is important to note that with only two participants per group and only one completing each arm of the trial, these numbers are based on an extremely small number of people, which means very little can be drawn from them about broader patterns. 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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NCT05142228 · results posted 22 March 2024
According to the results reported on ClinicalTrials.gov, this trial (NCT05142228) was designed to look at a medication called erenumab-aooe compared to a placebo (an inactive dummy treatment) in people with trigeminal neuropathic pain — a type of ongoing facial nerve pain. The trial aimed to measure things like changes in daily pain scores, the impact of pain on everyday activities such as eating and talking, and effects on anxiety and depression. There were two groups in the study: one receiving erenumab-aooe and one receiving placebo. The reported data shows that only one participant was enrolled in the erenumab-aooe group, and no participants were enrolled in the placebo group. That single participant completed the study, and no one dropped out. Because of this very small number of participants, no outcome measurement data was reported for any of the primary or secondary outcomes — including pain score changes, quality of life measures, or anxiety and depression scores. The data was simply not reported for these measures. Given that only one person took part in this trial overall, the study was far too small to produce any meaningful results across any of its intended outcome measures, and the reported data reflects this. No conclusions about the outcomes being measured can be drawn from the numbers 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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NCT03952377 · results posted 10 January 2024
According to the results reported on ClinicalTrials.gov, this trial enrolled 56 people in total across three groups: 18 received a saltwater injection (used as a placebo-style comparison), 21 received a lower dose of a drug called SX600 (12.5 mg), and 17 received a higher dose of SX600 (25 mg). Most participants completed the study — 16, 19, and 16 respectively across the three groups. The trial was measuring whether SX600, given by injection, could reduce severe leg pain (the kind that can come with back or nerve problems), and it also tracked participants' overall sense of wellbeing, disability levels, and quality of life. The reported data shows that for the main thing being measured — the number of people whose worst daily leg pain dropped by 50% or more — 2 out of 18 people in the saltwater group reached that level, compared with 10 out of 21 in the lower-dose SX600 group and 10 out of 17 in the higher-dose group. For the secondary measures, the reported data shows that across multiple time points, between roughly 17% and 47% of people in the saltwater group reported a 50% or greater drop in leg pain, compared with roughly 39–53% in the lower-dose group and 44–67% in the higher-dose group. When participants were asked to rate their overall change in how they were functioning ("Patient Global Impression of Change"), the proportion who said they felt "much improved" or "very much improved" ranged from about 17–50% in the saltwater group, 37–45% in the lower-dose group, and 53–60% in the higher-dose group across the different time points measured. Disability scores and quality-of-life scores were also tracked at multiple time points; the reported figures suggest scores shifted across all three groups over the course of the study, though the specific meaning of those shifts would require clinical interpretation. 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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NCT02510261 · results posted 6 December 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT02510261) enrolled 211 participants across three groups. These were people who had previously taken part in earlier studies of a medicine called patisiran: 49 people who had received a dummy treatment (placebo) in the earlier study, 137 who had received patisiran in that same earlier study, and 25 who had received patisiran in a different earlier study. The trial was measuring things like unwanted medical events that caused people to stop the study, as well as changes over time in nerve damage scores and quality of life scores. The reported data shows that for the primary measure — the percentage of people who stopped the study because of an unwanted medical event — the figures were 49% in the prior placebo group, 16.8% in the larger prior patisiran group, and 0% in the smaller prior patisiran group. For the nerve damage scores (measured on numbered scales where higher scores generally mean greater nerve damage), the reported data shows that all three groups had increases in their scores over time, meaning nerve damage scores were higher at later time points than at the start. For example, on one five-year nerve score measure, the prior placebo group's score changed by about 11.45 points, the larger prior patisiran group by about 10.72 points, and the smaller prior patisiran group by about 11.18 points. On quality-of-life scales measured at year five, changes were small or mixed across the groups, with the smaller prior patisiran group reporting an improvement of 18.0 points on one quality-of-life questionnaire, while the other two groups showed small worsening on that same measure. The reported data also shows starting scores varied noticeably between groups at the beginning of this study — for instance, the prior placebo group had notably higher nerve damage scores at the outset than the prior patisiran groups — which the trial's design reflects, as these groups came from different earlier studies with different treatment histories. It is worth noting that a substantial number of participants did not complete the study: 28 of 49 in the prior placebo group, 42 of 137 in the larger prior patisiran group, and 3 of 25 in the smaller prior patisiran group did not finish. 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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NCT03783689 · results posted 29 November 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03783689) enrolled 38 people in total — 19 in a treatment group and 19 in a control group. The trial was looking at pain after limb amputation, specifically pain in the remaining part of the limb ("residual limb pain") and/or the sensation of pain in the limb that is no longer there ("phantom limb pain"). The main things being measured were how many participants had their pain cut by at least half, and how many experienced a side effect thought to be related to the study. The reported data shows that, for the main pain outcome, 6 out of 19 people in the treatment group and 3 out of 19 in the control group recorded at least a 50% reduction in their pain scores over weeks 5 to 8 of the study. For the second primary measure — side effects linked to the study — 10 people in the treatment group and 6 in the control group experienced at least one such event. For the secondary outcomes, the reported data shows results across several questionnaires measuring how much pain disrupted daily life (Pain Interference and Pain Disability Index), how participants rated their own overall change (Patient Global Impression of Change, scored from −3 to +3), and how much participants tended to dwell on or feel overwhelmed by pain (Pain Catastrophizing Scale). For the Global Impression of Change, the treatment group's average score at the earliest reported time point was 1.8 and the control group's was 1.0 (on the −3 to +3 scale). For the Pain Catastrophizing Scale, the treatment group's average score moved from 17.6 at the start to 8.3 at the final time point, while the control group's moved from 24.1 to 19.2; noting that the two groups started with different baseline scores, so a direct comparison should be interpreted carefully. Some of the secondary outcome data points (particularly for later time points in the crossover portion of the study) were not reported for the control group, so a full side-by-side comparison for all time points is not possible from the available 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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NCT00220337 · results posted 24 July 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT00220337) enrolled 371 people who all received the medication lacosamide. There was no comparison group — everyone in the study received the same treatment. Of the 371 who started, 192 completed the trial and 179 did not finish. The trial was primarily designed to monitor and record a range of body measurements and medical events while participants were taking lacosamide, including any untoward medical occurrences, blood test results, and urine test results. The reported data shows that 80.9% of participants experienced at least one adverse event (that is, any unwanted medical occurrence noted during the study — this does not necessarily mean the medication caused it). For blood test results during the dose-increase period, the reported data shows that notable abnormalities in individual blood measurements were generally low, ranging from 0% to 1.4% of participants depending on what was being measured. During the longer maintenance period, those figures were also generally low but slightly higher for some measures, ranging from 0.3% to 6.2%. For chemistry panels (liver enzymes, kidney markers, electrolytes and similar), the proportions with notable abnormalities were also small across both periods, with most measures sitting at 0% to around 4.7% of participants. For the urine pH tracking, the reported data shows that of the 194 participants who had a urine pH reading of 5.0 at the start, the majority (194) were recorded at that same level, with smaller numbers recorded at different levels at their last visit, and 4 had no 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.
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NCT03267810 · results posted 22 June 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03267810) enrolled 26 people in total — 13 in each group. Participants were randomly assigned to receive either active TENS (transcutaneous electrical nerve stimulation, a device that delivers mild electrical pulses through the skin) or sham TENS (a dummy version designed to look the same but not deliver the active treatment). The trial was measuring whether participants went on to develop chronic neuropathic pain (persistent nerve pain) after spinal cord injury, and how severe any such pain symptoms were. The reported data shows that, among those who completed the study, 31% of participants in the active TENS group scored at or above the threshold for neuropathic pain on a symptom checklist, compared with 46% in the sham TENS group. For a separate pain symptom severity scale (scored 0–100, where higher means more severe symptoms), the active TENS group recorded an average score of 23, while the sham TENS group recorded 14. On a scale measuring how much pain interfered with daily activities, mood, and sleep (scored 0–30), the active TENS group scored 0 and the sham TENS group scored 1. For depressive symptoms (scored 0–27), the active TENS group scored 4 and the sham TENS group scored 1. Regarding adverse events (unwanted effects possibly related to the treatment), 1 participant in the active TENS group and 2 participants in the sham TENS group reported them, though the data does not describe the nature of those events in detail. It is worth noting that only 10 of the 13 active TENS participants and 12 of the 13 sham TENS participants completed the study, and the overall numbers involved were quite 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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NCT04156802 · results posted 12 May 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT04156802) enrolled 38 people in total across four groups. Participants received one of four types of brain stimulation — either a real or a "sham" (inactive/dummy) version of a technique called Theta Burst Stimulation (TBS), delivered to one of two areas of the brain: the medial prefrontal cortex (mPFC, a region involved in how the brain processes pain) or the motor cortex (MC, a region that controls movement). The trial was measuring whether this type of brain stimulation changed how much pain and discomfort participants reported. Of the 38 who started, 29 completed the study. The reported data shows the main outcome was the percentage change in self-reported pain scores compared to each participant's starting (baseline) level, where a positive number means pain went up and a negative number means pain went down. For the group receiving real TBS to the mPFC, the reported figure was a 47% increase from baseline. For the sham (dummy) TBS to the mPFC group, the reported figure was a 13% increase. For the group receiving real TBS to the motor cortex, the reported figure was a 30% decrease from baseline. For the sham TBS to the motor cortex group, the reported figure was an 18% decrease. Two other planned measurements — one involving a pressure-based pain threshold test and one involving brain scan (MRI) activity — were listed in the trial registration but no numbers were 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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NCT03094832 · results posted 31 March 2023
According to the results reported on ClinicalTrials.gov, this trial (NCT03094832) looked at a medicine called miransertib in people with two rare conditions — PROS (PIK3CA-related overgrowth spectrum) and PS (Proteus syndrome). The trial was run in two parts (Part A and Part B), with Part B divided into several smaller groups, including a compassionate use group for people who needed access outside the main study. In total, 50 people started the trial across all groups. The trial was primarily measuring how many participants experienced any unwanted medical event (called an "adverse event") while taking the medicine, and how many stopped taking the medicine because of such an event. The reported data shows that in Part A (17 participants with PROS or PS), all 17 experienced at least one adverse event, and 2 stopped taking the medicine because of one. In Part B's main cohort of 22 people with PROS, 20 experienced at least one adverse event, and none stopped treatment because of an adverse event. The single participant in the PS-only cohort (Cohort 2) had no adverse events reported. Of the 8 participants in the mixed PROS/PS cohort (Cohort 3), 6 experienced at least one adverse event, and none stopped treatment due to one. The one treated participant in the compassionate use group experienced one adverse event and did not stop treatment because of it. It is worth noting that only 4 participants across the entire trial were recorded as having fully completed the study. The reported data does not include results for any secondary outcome measures, 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.
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NCT04051944 · results posted 3 November 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT04051944) enrolled 21 adults who received a medicine called rozanolixizumab. Participants were split into two groups: 11 people who were newly starting this treatment, and 10 people who had received it previously as part of an earlier study. The trial was measuring experiences with the treatment, including any unwanted or unexpected medical events (called adverse events) that occurred during or shortly after receiving the medicine. The reported data shows that the primary — that is, the main — thing being tracked was the number of participants who experienced a "treatment-emergent adverse event" (TEAE). This means any unwanted medical event that either appeared for the first time, or got worse, after starting the medicine and up to eight weeks after the last dose. According to the results reported on ClinicalTrials.gov, 10 out of 11 participants in the newly treated group, and 10 out of 10 participants in the previously treated group, had at least one such event recorded. It is important to note that recording an adverse event does not by itself mean the medicine caused it — it simply means the event happened during the study period. No secondary outcome measure data appears to have been reported in the structured results 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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NCT03821675 · results posted 9 May 2022
According to the results reported on ClinicalTrials.gov, this trial involved 38 people in total — 19 in an "Active" group who received electrical stimulation therapy, and 19 in a "Sham" group who received a dummy (inactive) version of the treatment. The trial was measuring changes in foot and lower-leg circulation, wound size, foot sensation, and tissue oxygen levels (how much oxygen is getting to the skin) in people with lower-limb wounds. By the end of the trial, 16 people completed the Active group and 17 completed the Sham group, with a small number not finishing in each group. The reported data shows the following numbers for the two main (primary) outcomes. For skin perfusion pressure — a measure of how well blood is circulating in the lower leg, recorded in millimetres of mercury (mmHg) — the Active group recorded 65.1 mmHg and the Sham group recorded 72.2 mmHg. For wound size, measured in square centimetres (cm²), the Active group recorded 5.8 cm² and the Sham group recorded 3.2 cm². For the secondary outcomes, foot sensation (measured in volts using a vibration device) was reported as 20.2 volts in the Active group and 32.1 volts in the Sham group. Tissue oxygen saturation — how much oxygen is in the skin tissue — was reported as 72.3% for the Active group and 73.9% for the Sham group overall; a separate measurement taken at 60 minutes from the start recorded 73.5% for the Active group, while the Sham group figure at that time point was not reported in the data. An additional circulation measure recorded 79.9 mmHg for the Active group, with no corresponding Sham figure reported. It is worth noting that these numbers represent the values recorded at the end of the study period, and the data as submitted does not include the starting (baseline) figures needed to calculate how much each group changed over time. This means the reported numbers should be read as final observed values rather than as a measure of change from the beginning of 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.
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NCT03254394 · results posted 9 March 2022
According to the results reported on ClinicalTrials.gov, this trial (NCT03254394) enrolled 26 people in total — 12 in a group receiving a placebo alongside a chemotherapy regimen called FOLFOX, and 14 in a group receiving lidocaine (a local anaesthetic) alongside the same chemotherapy. The trial was looking at a well-known side effect of one of the chemotherapy drugs (oxaliplatin): a painful sensitivity to cold, as well as longer-term nerve-related symptoms sometimes called chemotherapy-induced peripheral neuropathy (numbness, tingling, or pain in the hands and feet). All participants started the study, 12 in each group completed it, and 2 people in the lidocaine group did not finish. The reported data shows that the main thing being measured was how much cold pain and cold unpleasantness participants experienced over time, scored on a scale of 0–10 each day and then added up across each two-week treatment cycle (with a combined score that could range from 0 to 140 — higher meaning more discomfort). The placebo group reported an average cold pain score of 16.4 and an average cold unpleasantness score of 33.1, while the lidocaine group reported average scores of 9.5 and 25.4 respectively. For the nerve symptom questionnaires, the reported data shows that changes from the start of the study to around 12 weeks were small in both groups (scores of 2 versus 4 on one questionnaire, and 0 versus 0 on another). By the final follow-up at around 34–36 weeks, the reported scores had changed more, with the lidocaine group showing larger increases on both questionnaires (37.0 versus 17.0, and 13.5 versus 3.0 — where higher numbers mean more symptoms reported). The reported total amount of chemotherapy drug received was also noted: the placebo group received an average of approximately 1,162 mg of oxaliplatin in total, compared with approximately 1,295 mg in the lidocaine 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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NCT02722434 · results posted 12 January 2022
According to the results reported on ClinicalTrials.gov, this trial enrolled 50 people in total — 25 in each group. One group received MC5-A Scrambler Therapy (a device that delivers electrical signals to the skin) and the other received TENS Therapy (a more commonly known device that also uses mild electrical pulses on the skin). All participants had nerve-related symptoms — either pain or tingling in their hands or feet — caused by chemotherapy treatment. The main thing the trial was measuring was how many people in each group had at least a 50% reduction in their worst symptom (pain or tingling) by day 14 of treatment. The reported data shows that, of the people who completed the main measurement point, 10 out of 24 participants in the Scrambler Therapy group and 5 out of 22 participants in the TENS group reported at least a 50% reduction in their primary symptom by day 14. The trial also looked at whether participants said they would recommend their assigned therapy to others with similar problems: 16 out of the Scrambler Therapy group said "yes," compared with 7 out of the TENS group; none in the Scrambler group said "no," while 7 in the TENS group said "no"; and 5 in the Scrambler group versus 3 in the TENS group said "unsure." The reported data also shows small changes in neuropathy-related scores (covering sensory, motor, and automatic body functions) from the start of the trial to week 10 in both groups, with negative numbers indicating a small decrease in reported symptoms across both groups. The number of participants using paracetamol (acetaminophen) for pain was similar in both groups — 8 in the Scrambler group and 9 in the TENS group. Data for the gene expression and brain scan (fMRI) components of the trial 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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NCT01553149 · results posted 30 November 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 75 children or young people in total — 37 in a low-dose group and 38 in a high-dose group — who were given a medicine called lenalidomide. The trial was looking at two main things: how many participants showed a complete or partial shrinkage of their tumour, and how many showed their disease getting worse within the first six months of treatment. It also tracked longer-term outcomes over roughly three years. The reported data shows that in the low-dose group, 4 out of 37 participants showed a complete or partial tumour response, and 6 showed early disease progression. In the high-dose group, 4 out of 38 showed a complete or partial response, and 4 showed early disease progression. For the longer-term measures, the estimated probability of being free from disease-related events at three years was reported as approximately 38% for the low-dose group and 39% for the high-dose group. The estimated probability of being alive at three years was approximately 95% for the low-dose group and 92% for the high-dose group. Regarding a measure of unwanted side effects after two dose reductions, 2 participants in the low-dose group and 16 in the high-dose group were reported to have experienced additional significant toxic events. The trial also measured the concentration of lenalidomide in the blood, recording an average of 15.1 nanograms per millilitre in the low-dose group and 178.8 nanograms per millilitre in the high-dose 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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NCT02447172 · results posted 27 August 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 524 people in total across three groups: 262 people received a gentamicin-containing sponge, 130 received a placebo (dummy) sponge, and 132 received no sponge at all. The trial was measuring outcomes in people with infected foot ulcers, focusing mainly on how many participants had all their signs and symptoms of infection clear up by the first follow-up visit. The reported data shows that the primary outcome — the percentage of people whose infection signs and symptoms fully resolved — was 69% in the gentamicin sponge group, 41% in the placebo sponge group, and 36% in the no-sponge group. For the secondary outcomes, the reported data shows that the number of participants who developed a new infection during the trial was 11 in the gentamicin group, 2 in the placebo group, and 4 in the no-sponge group. The average time for signs and symptoms to clear was reported as 8 days across all three groups. Regarding amputations linked to the treated ulcer, 3 participants in the gentamicin group, 0 in the placebo group, and 2 in the no-sponge group were reported as having had an amputation. 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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NCT02124772 · results posted 14 July 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT02124772) enrolled a total of 139 children and young people across four parts (Parts A, B, C, and D). It studied a drug called trametinib, given either on its own or combined with another drug called dabrafenib, across a range of childhood cancer types — including neuroblastoma, low-grade glioma (a type of brain tumour), neurofibromatosis type 1 with plexiform neurofibromas, and BRAF-mutant solid tumours. The trial tested different doses and looked at how the drug moved through the body (called pharmacokinetics) and recorded any unwanted medical events that occurred during treatment. The reported data shows that for the primary outcomes, all participants in Parts A and B who received trametinib alone were recorded as having experienced at least one treatment-emergent adverse event (that is, any unwanted medical change that occurred after starting treatment — ranging from minor to serious). Regarding how the drug behaved in the body, the average steady-state level of trametinib in the blood (a measure of how much drug was present on an ongoing basis) ranged from about 5.76 ng/mL at the lowest dose tested up to about 21.3 ng/mL at the highest dose in Part A, with Part B tumour groups sitting between approximately 13.2 and 15.8 ng/mL. For the secondary measures, the peak blood level of trametinib reached after a dose ranged from roughly 9.61 to 32.6 ng/mL depending on the group, and the time taken to reach that peak was generally between 1 and 2 hours across all groups. The total drug exposure over time (area under the curve) ranged from approximately 122 to 413 hours×ng/mL across the various groups. Some secondary outcome figures were not reported for all subgroups in the submitted data. The reported data shows that completion numbers varied considerably across groups — for example, 14 out of 20 participants completed Part D's low-grade glioma group, while none of the 3 participants in the lowest-dose Part A group completed the study. The reasons for not completing were not broken down in the figures provided 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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NCT01276379 · results posted 2 July 2021
According to the results reported on ClinicalTrials.gov, this trial enrolled 221 people, all of whom received a combination chemotherapy regimen (either FOLFIRI or FOLFOX-6) together with a targeted medicine called cetuximab. Of those, 181 completed the study and 40 did not. The trial was primarily measuring how long participants went without their cancer growing or spreading — known as "progression-free survival" — and also looked at how long participants lived overall, how tumours responded to treatment, and how often unwanted side effects occurred. Results were broken down by whether participants had a particular gene change called a BRAF mutation, as this was thought to potentially influence outcomes. The reported data shows that, for the main measure of time without disease progression, participants without the BRAF mutation recorded a median (the midpoint value for the group) of 11.4 months, while those with the BRAF mutation recorded a median of 5.9 months. For overall survival — the time from starting treatment until death or being lost to follow-up — the reported median was 32.6 months for the non-mutated BRAF group and 9.3 months for the mutated BRAF group. The reported median duration of response to treatment (for the whole group combined) was 8.66 months. Regarding tumour response in the non-mutated BRAF group, 16 participants were reported as having a complete response (no detectable tumour), 106 had a partial response, and 25 had stable disease; in the mutated BRAF group, 1 had a complete response, 6 had a partial response, and 6 had stable disease. Side-effect figures were also reported, but the data as submitted does not include enough labelling detail to describe each number clearly, so those specific breakdowns cannot be fully 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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NCT03865953 · results posted 23 April 2021
According to the results reported on ClinicalTrials.gov, this trial (NCT03865953) looked at a drug called LAT8881, taken by mouth, compared to a placebo (a dummy treatment with no active ingredient) in people with neuropathic pain — a type of pain caused by damage or problems with the nervous system. A total of 53 people were enrolled across two groups: 25 started on LAT8881 then switched to placebo, and 28 started on placebo then switched to LAT8881. This was a "crossover" design, meaning everyone received both treatments at different times, separated by a washout period. By the end of the trial, 48 people completed both treatment periods. The reported data shows that the main thing being measured was the change in pain scores using an 11-point scale, where 0 means "no pain" and 10 means "the worst pain imaginable." After four weeks of treatment, people taking LAT8881 reported an average reduction in their pain score of 0.87 points, while people taking the placebo reported an average reduction of 0.74 points. The reported data also shows that when looking at the largest single drop in pain scores recorded during the study, the LAT8881 group showed a maximum average reduction of 1.53 points, compared to 1.55 points for the placebo group. For weekly check-ins at one, two, and three weeks, both groups started with an average pain score of around 6.18, and the changes reported at each time point were similar between the two groups. Among the additional results reported, 20 out of the participants taking LAT8881 and 19 taking placebo recorded at least a 30% drop in their pain score over four weeks. For a 50% or greater drop, 6 participants in the LAT8881 group and 9 in the placebo group met that threshold. 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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NCT00370695 · results posted 17 December 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 15 participants and involved a single treatment group using a device called the Precision Spinal Cord Stimulation System. The trial was designed to measure back pain severity at 12 weeks after the device was switched on, comparing those results to each participant's pain levels at the start of the study. The reported data shows that of the 15 people who started the trial, only 2 reached the 12-week post-activation point, and none of the participants completed the study overall. All 15 participants were recorded as "not completed." The primary outcome — the comparison of back pain severity between the starting point and 12 weeks after activation — has no measurement data reported on ClinicalTrials.gov, meaning no numerical results were submitted for this outcome measure. Because the trial did not reach completion and no outcome numbers were reported, it is not possible to draw any conclusions from this study about what the device may or may not do. The reasons why participants did not complete the study were not included 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.
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NCT03360344 · results posted 8 October 2020
According to the results reported on ClinicalTrials.gov, this trial looked at people with carpal tunnel syndrome and involved 44 participants spread across three groups: 15 people received Kinesio Tape (a type of elastic therapeutic tape applied to the skin), 16 received standard care (the usual treatment approach), and 13 were in a control group (who received no specific intervention). By the end of the study, 15, 15, and 12 participants respectively completed the trial, with one person from each of the standard care and control groups not finishing. The trial measured pain levels, hand and finger strength, and how much carpal tunnel symptoms affected daily activities, over a three-week period. The reported data shows the following numbers across the three groups (Kinesio Tape / Standard Care / Control) at the end of the study. For pain measured on a 0–10 number scale, scores were reported as 0.01, 0.17, and 0.30. For pain measured on a visual sliding scale scored 0–100, scores were 21.4, 32.6, and 24.2. For grip strength (measured in pounds using a hand-held device), the reported figures were 55.47, 64.8, and 52.7 pounds, and finger pinch strength was 12.2, 12.4, and 11.8 pounds. For symptom severity on a carpal tunnel questionnaire (scored 1–5, where higher means more severe), all three groups scored between 1.9 and 2.0. For the functional difficulty questionnaire (also 1–5), scores were 1.5, 1.8, and 1.7 respectively. It is worth noting that some of the data provided appears across multiple time points, and the reporting on ClinicalTrials.gov does not always make it straightforward to identify exactly which numbers belong to which time point — so some figures may not be directly comparable. The reported data shows numbers only; this summary does not draw any conclusions about what those numbers mean for treatment decisions. 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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NCT03530345 · results posted 6 August 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03530345) looked at a medication called neridronic acid in people with Complex Regional Pain Syndrome (CRPS), a chronic pain condition. A total of 57 people entered the first part of the trial — 28 received neridronic acid and 29 received a placebo (an inactive dummy treatment). The trial was primarily measuring whether neridronic acid changed participants' self-reported pain levels over 12 weeks, using an 11-point scale where 0 meant "no pain" and 10 meant "the worst pain imaginable." The reported data shows that, on average, participants in the neridronic acid group recorded a change of −1.23 points on the pain scale from the start of the trial to week 12, while participants in the placebo group recorded a change of −0.16 points over the same period. In plain terms, both groups reported some reduction in their pain scores, with the neridronic acid group reporting a somewhat larger decrease on the scale. For the secondary outcomes — including pain scores at week 26, the proportion of people whose pain dropped by at least 30%, and measurements of sensitivity to touch and pressure — the data was not reported in the results 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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NCT00278629 · results posted 23 July 2020
According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people with a nerve condition called CIDP (chronic inflammatory demyelinating polyneuropathy). All participants received a procedure involving transplantation of their own blood stem cells. The trial was measuring whether participants survived the treatment and up to five years afterwards, and also tracking things like whether they still needed medication, how well they could walk, and their overall muscle strength and function. Sixty-six of the 80 participants completed the study, while 14 did not complete it (the reasons were not detailed in the reported data). The reported data shows that 66 participants survived the treatment itself, and 64 survived through to the five-year follow-up point. For the secondary measurements, the data shows that 48 participants were reported to be in remission (stable or improving nerve condition without immune-suppressing medication) at an early follow-up point, with that number gradually changing across later time points — reported as 48, 47, 45, 39, and 35 participants respectively at subsequent check-ins. Regarding walking ability, the number of participants reported as being able to walk without any assistance started at 19 before the procedure, then rose across follow-up time points to 41, 49, 48, 48, 43, and 35 participants. On a muscle strength and disability scale (where 0 means no movement at all and 60 means fully normal strength), the reported average score before the procedure was 51.8 out of 60, rising to 54.8 shortly after, and then recorded at 57 out of 60 across the remaining follow-up 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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NCT03297294 · results posted 4 June 2020
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called EMA401 (taken twice daily) compared to a placebo (a dummy pill) in people with nerve pain from a condition called post-herpetic neuralgia — ongoing pain that can follow a shingles infection. In the main treatment phase, 70 people were assigned to EMA401 and 67 to the placebo. Participants rated their pain daily using an 11-point scale (where 0 means no pain and 10 means the worst imaginable pain). The trial also included a later withdrawal phase involving smaller groups who had completed the first stage. The reported data shows that after 12 weeks, the average pain score for people taking EMA401 dropped by approximately 1.0 to 1.9 points on the 11-point scale, depending on the time point measured, while the placebo group's scores dropped by approximately 0.8 to 1.3 points. For the "worst pain" score, the EMA401 group showed a reported drop of about 1.63 points compared to 1.28 points in the placebo group. On a separate questionnaire measuring how pain interfered with daily life (scored out of 70, where lower is better), the EMA401 group's score fell by about 12 points and the placebo group's by about 11 points. The reported data also shows that around 34% of EMA401 participants and 25% of placebo participants achieved at least a 30% reduction in their average pain score; at a later time point, those figures were reported as approximately 53% and 40% respectively. It is worth noting that a substantial number of participants — 38 in the EMA401 group and 37 in the placebo group — did not complete the main treatment phase, and the reasons for this 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT03094195 · results posted 14 May 2020
According to the results reported on ClinicalTrials.gov, this trial (NCT03094195) enrolled 129 people across three groups during the main double-blind phase: 43 people received a lower dose of EMA401 (25 mg twice daily), 43 received a higher dose (100 mg twice daily), and 43 received a placebo (a dummy treatment with no active ingredient). A planned third active dose (300 mg twice daily) was never started because the trial was ended early. The trial was measuring whether EMA401, at different doses, had an effect on pain scores in people with a nerve pain condition, using an 11-point scale where 0 means "no pain" and 10 means "the worst pain imaginable." A smaller (more negative) number in the results means pain scores went down from where they started. The reported data shows that for the primary outcome — tracking how average daily pain scores changed over 12 weeks — no numbers were reported, because the trial ended before the full dose-response analysis could be completed. For the secondary outcomes, the reported changes in average pain scores from the starting point to week 12 were: minus 0.4 points for the 25 mg group, minus 0.9 points for the 100 mg group, and minus 0.5 points for the placebo group (on the 11-point scale). For "worst pain" scores, the reported changes were minus 1.04 points (25 mg), minus 1.96 points (100 mg), and minus 1.49 points (placebo). When participants were asked how their overall condition had changed, 20 people in the 25 mg group, 18 in the 100 mg group, and 12 in the placebo group reported feeling "much improved" or "very much improved." The reported data also shows that roughly 7.5% of the 25 mg group, 15.6% of the 100 mg group, and 12.6% of the placebo group achieved at least a 30% reduction in their pain score. 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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NCT00553540 · results posted 25 November 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT00553540) involved 50 people in total, split evenly into two groups of 25 — a Control Group and a Test Group. The trial was measuring changes in low back pain over a period of 24 weeks, with pain checked at weekly intervals. By the end of the study, 23 people in the Control Group and 20 people in the Test Group had completed it, meaning 2 and 5 participants respectively did not finish. The reported data shows that pain was measured using a numeric scale running from 1 (least painful) to 10 (most painful). Scores were recorded each week for 24 weeks and then averaged across all those time points. The Control Group recorded an average pain score of 2.58 out of 10, while the Test Group recorded an average pain score of 1.80 out of 10. These are the only outcome figures reported — no other measures (such as secondary outcomes) appear to have been submitted to ClinicalTrials.gov for this trial, so no further numbers can be described here. It is worth noting that these figures represent averages across the full 24-week period, not a single snapshot in time. The reported data does not include any further breakdown of how scores changed week by week, and no additional details about how the two groups differed in their characteristics or treatments were included 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01744704 · results posted 9 September 2019
According to the results reported on ClinicalTrials.gov, this trial tested a substance called rhNGF (a laboratory-made version of a naturally occurring protein called Nerve Growth Factor) as eye drops, at several different dose levels, in a small number of healthy volunteers. The study was run in stages — a small "sentinel" phase, then Part A, then Part B — and included 74 participants in total across all groups, all of whom completed the study. The trial was primarily measuring how the eye responded to the drops, looking at things like eye discomfort, vision sharpness, the stability of the tear film on the eye's surface, staining of the eye's surface, pressure inside the eye, and the appearance of the back of the eye. The reported data shows that changes across all these measures were very small across the different dose groups. Eye discomfort scores (measured on a 0–100 scale where higher means more discomfort) showed changes ranging from −1 to +3 units across groups. Vision sharpness scores changed between −6 and +3 units on the scale used. Tear film stability changed by between −2.6 and +1.7 seconds, and surface staining scores changed by similar small amounts. Eye pressure (measured in millimetres of mercury) shifted by between −2 and +1 units across groups. The reported data shows that 0% of participants had abnormal findings when the back of the eye was examined across 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00949325 · results posted 11 March 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 24 people across three dose groups testing a drug called temsirolimus. The trial was split into two parts: the first part looked at how many people in each dose group experienced serious side effects severe enough to limit the dose (called "dose-limiting toxicities"), and the second part measured how long participants lived and how long their disease stayed stable at the dose identified as the maximum tolerable level (20 mg/m²). The reported data shows that in the three dose groups, 1, 4, and 3 participants respectively experienced dose-limiting toxicities. For participants treated at the maximum tolerable dose, the middle point (median) for overall survival — meaning the time from starting treatment until death from any cause — was reported as 254 days. The median time before disease worsened or death occurred (called progression-free survival) was reported as 74 days. Among participants treated at the two dose levels (20 mg/m² and 27 mg/m²) combined, the reported data shows that no participants had a complete disappearance of their disease, 1 had a partial reduction in tumour size (at least 30% shrinkage), 8 had stable disease (neither enough shrinkage nor enough growth to meet the other categories), and 5 had disease progression (worsening). The trial also measured drug levels in the blood; however, interpreting those technical figures is not straightforward without specialist knowledge and are best discussed with a doctor. 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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NCT01737398 · results posted 23 January 2019
According to the results reported on ClinicalTrials.gov, this trial (NCT01737398) enrolled 173 people in total — 113 in the inotersen group and 60 in the placebo group (a placebo is a dummy treatment with no active ingredient, used for comparison). Of those, 112 and 60 respectively received at least one dose of the study drug. The trial ran for about 66 weeks and was measuring two main things: changes in nerve damage (using a scoring tool called the mNIS+7, where a higher score means worse nerve function) and changes in quality of life (using a questionnaire called the Norfolk QoL-DN, where a higher score means a poorer quality of life). The reported data shows that, at week 66, the average mNIS+7 nerve-impairment score had changed by +4.16 points in the inotersen group and +23.89 points in the placebo group from where each group started — in both cases scores went up (meaning more impairment), but the increase was smaller in the inotersen group. For the quality-of-life questionnaire, the reported average change was −0.08 points in the inotersen group (essentially no change from the starting point) and +10.77 points in the placebo group (a worsening). The reported data also shows results for several secondary measures: the symptoms sub-score of the quality-of-life questionnaire changed by −1.40 (inotersen) versus +1.18 (placebo); the physical functioning sub-score changed by +1.05 (inotersen) versus +8.74 (placebo). For body weight-related measures at week 65, a combined weight-and-nutrition index (modified BMI) changed by −73.32 (inotersen) versus −85.21 (placebo), and standard BMI changed by −0.24 (inotersen) versus −0.87 (placebo) — both groups showed a decrease in 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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NCT02096471 · results posted 10 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 19 participants, all of whom received the study drug called PD-0325901 (also referred to as "Agent PD-0325901"). The trial was studying this treatment in people with plexiform neurofibromas — a type of tumour that grows along nerves, associated with a condition called neurofibromatosis type 1 (NF1). Of the 19 people who started the trial, 6 completed it and 13 did not finish. The main thing the trial was measuring was whether the volume (size) of the target tumour changed by 20% or more, as assessed by specialised 3D MRI scans. The reported data shows that, for the primary outcome, none of the 19 participants had a complete disappearance of their target tumour, and none experienced a 20% or greater increase in tumour size (what researchers call "progressive disease"). Eight participants were reported to have had a 20% or greater reduction in tumour volume (a "partial response"), and 11 participants had tumour measurements that fell in between — neither a meaningful shrinkage nor a meaningful growth ("stable disease"). For up to two additional non-target tumours that were also measured, the reported data shows 2 participants had stable disease and none had a complete or partial response recorded. Regarding adverse events (unwanted health effects), the reported data notes that 2 out of 19 participants experienced serious adverse events, while all 19 participants had some form of adverse event recorded — though the detailed breakdown of those events was not included in the structured data provided. Some quality-of-life scores using pain and wellbeing scales were also reported, but the full context for interpreting those individual numbers was not provided in the structured 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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NCT02204982 · results posted 3 January 2019
According to the results reported on ClinicalTrials.gov, this trial enrolled 13 people in total — 6 in the group receiving duvelisib combined with rituximab, and 7 in the group receiving a placebo combined with rituximab. The trial was designed to compare these two treatments in people with a type of blood cancer, with the main goal of measuring how long participants went without their disease getting worse (called "progression-free survival"). The study was terminated early before it could fully complete. The reported data shows that because the trial was stopped early and so few people were enrolled, the main outcome — progression-free survival — was never formally analysed, and no figures for it were reported. For the secondary outcome, overall response rate (meaning how many participants showed a measurable response to treatment), the reported numbers were: in the duvelisib plus rituximab group, 3 participants had one category of response and 2 had another, while 0 had a third category and 0 had a fourth. In the placebo plus rituximab group, the reported data shows 0 in the first category, 1 in the second, 3 in the third, and 2 in the fourth. The specific labels for each response category were not included in the data provided, so a fuller breakdown cannot be described here. Of the 13 people who started the trial, only 2 completed it — both from the duvelisib group — and none from the placebo group completed it. The reasons for not completing were not detailed 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.
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NCT01397552 · results posted 4 December 2018
According to the results reported on ClinicalTrials.gov, this trial compared two medications — dexamethasone and methylprednisolone acetate — given by injection, to see which one did a better job of relieving pain. A total of 8 people took part, split evenly into two groups of 4. Participants were asked to come back at 2 weeks, 6 weeks, and 12 weeks to fill in questionnaires about their pain and to have a neurological examination (a check of how the nerves and muscles are working). The reported data shows that, of the 8 people who started the trial, 4 completed it — 1 person in the dexamethasone group and 3 people in the methylprednisolone acetate group. The remaining 4 participants (3 from the dexamethasone group and 1 from the methylprednisolone acetate group) did not complete the trial, though the reasons were not detailed in the data provided. For the primary outcome — which was measuring which medication was better at relieving pain — no numerical results were reported in the data submitted to ClinicalTrials.gov. This means it is not possible to describe what the pain scores or questionnaire results showed, as that information was not available 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.
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NCT02027701 · results posted 2 October 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 82 people, all of whom received a subcutaneous immunoglobulin treatment called IgPro20. The trial was studying people with a nerve condition called CIDP (a condition where the immune system affects the nerves, causing weakness and numbness). Of the 82 who started, 66 completed the trial and 16 did not. The trial was primarily measuring how often unwanted medical events (called "adverse events") occurred during each infusion of the treatment. It also tracked several measures of how participants' bodies were functioning over time, including how long it took before their condition worsened, and scores on disability and muscle strength scales. The reported data shows that the primary outcome — adverse events per infusion — averaged 0.032, meaning roughly 3 events were reported for every 100 infusions given. For the secondary outcomes, the reported median time until a participant's condition worsened (based on a disability scoring system called the INCAT scale) was 266 days. The reported data also shows that, on average, participants' scores on the INCAT disability scale and a muscle strength scale (MRC score, which runs from 0 to 80) did not change from their starting point — both showed a change of 0.0. Similarly, a daily activities scale (R-ODS) showed no average change from baseline. Average grip strength showed a small reported change of −0.7 kilopascals (a unit of pressure used to measure hand squeeze strength). 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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NCT01733407 · results posted 12 September 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01733407) enrolled 18 people in total — 9 in a sugar pill (placebo) group and 9 in an L-serine group. The trial was measuring disease severity in people with a nerve condition called Charcot Marie Tooth Neuropathy, using a scoring tool called the CMTNS (a scale from 0 to 36, where higher numbers mean more severe disease). It also measured several other things, including nerve fibre counts in skin, the body's automatic nervous system function (things like heart rate and blood pressure regulation), nerve electrical signals, and blood levels of two specific fatty substances called 1-deoxy-sphinganine and 1-deoxy-sphingosine. Seven of the nine people in the sugar pill group completed the trial, while all nine in the L-serine group completed it. The reported data shows the following numbers at the end of the trial. On the main CMTNS disease severity score, the sugar pill group averaged 25.67 and the L-serine group averaged 20.22 (lower scores represent less severe disease on this scale). For the automatic nervous system test (scored 0–10, where higher means more severe), the sugar pill group averaged 3.56 and the L-serine group averaged 2.22. For the skin nerve fibre count, the reported data shows figures of 34.67 (sugar pill) and 49.56 (L-serine) at one time point, and 0.89 (sugar pill) and 13.89 (L-serine) at another — though the data as reported does not specify which time points these correspond to. For the two blood lipid substances, 1-deoxy-sphinganine averaged 0.338 micromoles per litre (sugar pill) versus 0.112 (L-serine), and 1-deoxy-sphingosine averaged 0.698 (sugar pill) versus 0.337 (L-serine). Multiple nerve electrical signal readings were also reported across both groups, with values ranging from 0.00 to 10.84 microvolts depending on the specific measurement and group, though the data as submitted does not clearly label which reading corresponds to which nerve test. 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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NCT01960348 · results posted 6 September 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01960348) enrolled 225 people in total — 148 received patisiran (ALN-TTR02) and 77 received a placebo (an inactive treatment given for comparison). The trial was studying a condition involving nerve damage caused by a faulty protein called TTR, and the main thing being measured was change in a nerve impairment score called the mNIS+7 over 18 months. This score runs from 0 to 304, where a higher number means greater nerve impairment. By the end of the study, 138 people in the patisiran group and 55 in the placebo group had completed the trial. The reported data shows that, over 18 months, the mNIS+7 score in the patisiran group changed by an average of −6.03 points (meaning it went slightly down from where it started), while the placebo group's score rose by an average of 27.96 points (meaning impairment increased). For the secondary measures, the reported data shows similar patterns across the board. On the quality-of-life questionnaire (Norfolk QoL-DN, where higher is worse), the patisiran group's score changed by −6.7 and the placebo group's by +14.4. On the muscle-strength score (NIS-W), the patisiran group changed by +0.05 and the placebo group by +17.93. On the disability scale (R-ODS, where higher is better), the patisiran group changed by 0.0 and the placebo group by −8.9. Walking speed over 10 metres changed by +0.077 m/sec in the patisiran group and −0.235 m/sec in the placebo group. A nutritional measure (modified BMI) changed by −3.7 in the patisiran group and −119.4 in the placebo group. These figures represent the average changes from the start of the trial to 18 months for each group as submitted by the trial sponsor. No data was missing from the reported results for these 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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NCT01545076 · results posted 5 July 2018
According to the results reported on ClinicalTrials.gov, this trial (NCT01545076) looked at a treatment for CIDP — a condition affecting the nerves that can cause weakness and problems with movement in the arms and legs. The trial ran in several stages. First, 208 participants received an intravenous (into-the-vein) immunoglobulin treatment called IgPro10 to stabilise their condition; 172 of them completed this stage. Those who were stabilised were then randomly assigned to one of three groups for the next stage: a higher dose of a under-the-skin (subcutaneous) immunoglobulin treatment called IgPro20 (58 people), a lower dose of IgPro20 (57 people), or a placebo — a dummy treatment with no active ingredient (57 people). A separate group of 60 participants also went through a rescue treatment stage. The main thing the trial was measuring was how many participants in each group either experienced a "relapse" — meaning their disability score worsened by a set amount on a standard scale — or left the trial early for any reason. The reported data shows that, during the subcutaneous treatment stage, the percentage of participants who relapsed or withdrew was 32.8% in the higher-dose IgPro20 group, 38.6% in the lower-dose IgPro20 group, and 63.2% in the placebo group. For the secondary measures, the reported data shows that changes in the disability score (INCAT) from the start of this stage to the end were 0 points for both IgPro20 groups and 1 point for the placebo group. Grip strength in the dominant hand changed by −2.7 kilopascals in the higher-dose group, −0.6 kilopascals in the lower-dose group, and −6.6 kilopascals in the placebo group (a negative number meaning a reduction in grip strength). A muscle strength score (MRC) changed by 0 points in both IgPro20 groups and −2 points in the placebo group. A daily activity and social participation score (R-ODS) changed by 0 points in the higher-dose group, −2 points in the lower-dose group, and −3 points in the placebo group. For the time until relapse or withdrawal, the reported data shows a median (midpoint) of 79 days for the placebo group; a median figure was not reported for the two IgPro20 groups, suggesting more than half of participants in those groups had not relapsed by the end of 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT02349646 · results posted 26 June 2018
According to the results reported on ClinicalTrials.gov, this trial looked at a device called the Axium DRG Neurostimulator — an implantable device that delivers electrical signals to a specific part of the nervous system near the spine. A total of 33 people enrolled in the study. Of those, 24 went on to receive a trial version of the device, and 27 received the permanent implanted version. Sixteen participants completed the study, while 17 did not complete it. The reported data shows that participants who received the permanent implanted device rated their pain using a standard self-reported pain scale (where 0 means no pain and 10 means the worst imaginable pain). Before receiving the device, the average pain score was reported as 7.4 out of 10. The reported data shows scores then recorded at follow-up time points of 4.0, 3.4, and 3.8 — meaning the numbers reported at those later time points were lower than the starting score, though the specific timing of each follow-up measurement was not detailed in the submitted data. Regarding the second primary measure, the reported data shows that 13, 14, and 8 participants (at the respective follow-up points) were recorded as having at least a 50% reduction in their pain score compared to their starting level. It is worth noting that the study was relatively small, and 17 of the 33 people who started did not complete the trial — the reasons for this were not detailed 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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NCT00853580 · results posted 12 March 2018
According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people in the Lovastatin group and 72 in the Placebo group — 146 participants in total. The trial was measuring different aspects of thinking and attention in its participants, using a series of computerised and paper-based tests. The two main (primary) outcomes looked at visuospatial learning — the ability to remember patterns linked to locations on a screen — and sustained attention — the ability to stay focused while counting a series of sounds. Several additional (secondary) outcomes measured things like spatial memory, planning ability, the ability to stop a response quickly, and selective visual attention. The reported data shows the following numbers across the two primary outcomes. For the visuospatial learning test (where more errors means poorer performance), the Lovastatin group recorded 15.8 errors at one time point and 10.3 at another, while the Placebo group recorded 17.0 and 11.7 errors respectively. For the sustained attention test (where a higher score out of 10 means better performance), the Lovastatin group scored 6.0 then 7.3, and the Placebo group scored 5.7 then 6.8. For the secondary outcomes, the reported data shows broadly similar numbers between the two groups across all tests — including spatial memory errors, planning moves, response-stopping time in milliseconds, and visual attention timing scores — though the trial did not report whether any of these differences were considered meaningful. 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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NCT01261780 · results posted 6 November 2017
According to the results reported on ClinicalTrials.gov, this trial (NCT01261780) involved 14 participants in total — 7 in a group that used a sham (inactive/dummy) device and 7 in a group that used a device called the MC-5A. Of those, 5 people in each group completed the study, while 2 in each group did not finish. The trial was measuring changes in pain sensation using a sliding scale tool (called a mechanical Visual Analog Scale, or mVAS), where participants rated any painful feeling on a scale of 0 to 10, with 10 being the worst pain imaginable. This measurement was taken at three separate points during the trial and compared to each participant's starting (baseline) score. The reported data shows the following changes in pain ratings (where a negative number means the score went down from baseline, and a positive number means it went up). At the first measurement point, the sham group's score changed by +5.14 millimetres and the MC-5A group's score changed by −2.00 millimetres. At the second point, the sham group changed by +1.25 millimetres and the MC-5A group by +6.76 millimetres. At the third point, the sham group changed by −11.2 millimetres and the MC-5A group by +3.80 millimetres. For the secondary outcome — the number of participants who experienced adverse events (unwanted or unexpected experiences during the trial) — the reported data shows 4 participants in the sham group and 4 participants in the MC-5A group had at least one adverse event recorded. It is worth noting that this was a very small trial with only 14 participants, so the numbers above reflect a narrow group of people 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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NCT01625182 · results posted 19 September 2017
According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called fingolimod (also known as FTY720) compared to a placebo (a dummy treatment with no active ingredient) in people with a nerve condition called CIDP (chronic inflammatory demyelinating polyneuropathy). A total of 106 people took part — 54 received fingolimod and 52 received the placebo. The trial's main focus was measuring how long it took before a person's disability noticeably worsened, using a scoring tool called the adjusted INCAT Disability Scale, which rates how much difficulty a person has using their arms and legs (scored from 0 to 10, where a higher score means more difficulty). The reported data shows that, on average, the time before a confirmed worsening was recorded was 721 days in the fingolimod group and 540 days in the placebo group. The trial also measured hand grip strength (using a pressure-measuring device) and a self-reported daily activities score (the R-ODS, rated 0–100 where higher means less disability). For grip strength in the dominant hand, both groups showed a decline from their starting point — the fingolimod group reported changes of −2.6 and −0.8 kPa at two different time points, while the placebo group reported −3.8 and −3.9 kPa. Similar patterns were reported for the non-dominant hand. For the daily activities score, both groups also showed small declines from their starting scores, with the fingolimod group reporting changes of −6.4 and −5.7, and the placebo group −5.5 and −5.1. A negative number in these measures indicates a decline from the starting point. It is worth noting that 20 people in the fingolimod group and 11 in the placebo group did not complete the trial, which the reported data does not fully explain. The reported data shows the numbers as submitted by the trial sponsor, but does not on its own tell us why these differences between groups occurred or what they mean in a broader medical 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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NCT02643251 · results posted 9 August 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 138 people in total — 69 in each group. One group applied a clonidine hydrochloride topical gel at a 0.1% strength, while the other group applied a comparator gel (a different version of the same type of gel). The trial ran for 12 weeks and was primarily measuring changes in foot pain, using a standard 0-to-10 self-reported pain scale (where 0 means no pain and 10 means the worst pain imaginable). Not everyone who started the trial finished it — 58 out of 69 people completed the active gel group, and 67 out of 69 completed the comparator group. The reported data shows that, for the main outcome — average pain over the past 24 hours measured at week 12 — participants in the clonidine gel group reported a change of minus 1.2 points on the pain scale compared to where they started, while those in the comparator group reported a change of minus 1.4 points. In other words, both groups reported somewhat lower pain scores by the end of the trial than at the beginning, with the comparator group showing a slightly larger numerical reduction. For the secondary outcome — measuring the worst pain experienced in the past 24 hours — the reported changes were minus 1.29 points for the clonidine gel group and minus 1.48 points for the comparator group, a similar pattern to the main result. 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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NCT02094352 · results posted 14 June 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — two people in the ketamine infusion group and one person in the control group, making three participants in total. All three participants completed the study. The trial was designed to look at pain levels before and after treatment, tracking any changes over a six-month period using a pain rating scale (a numbered scale where participants rate how much pain they feel). The reported data shows that while the trial listed pain reduction as its primary outcome measure — specifically looking at changes in pain scores between the start of the study and six months after the infusion — no numerical results for this outcome were submitted to ClinicalTrials.gov. In other words, the actual pain score measurements were not reported in the data available, so it is not possible to describe what the numbers showed. It is also worth noting that with only three participants enrolled, this was an extremely small study, far smaller than most clinical trials. 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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NCT01495923 · results posted 11 April 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 145 people in total — 73 received epidural steroid injections (a procedure where steroid medication is delivered into the spine) and 72 took the oral medication gabapentin. All participants completed the study with no drop-outs recorded. The trial was measuring leg pain and back pain at one month and three months after starting treatment, using a simple 0–10 numeric pain scale where 0 means no pain and 10 means the worst imaginable pain. The reported data shows the following pain scores at one month: average leg pain was 3.3 for the injection group and 3.7 for the gabapentin group; worst leg pain was 4.9 for the injection group and 5.8 for the gabapentin group; and average back pain was 3.5 for the injection group and 3.6 for the gabapentin group. At three months, the reported data shows average leg pain was 3.4 for the injection group and 3.7 for the gabapentin group; worst leg pain was 5.2 for the injection group and 5.5 for the gabapentin group; and average back pain was 3.9 for the injection group and 3.7 for the gabapentin group. In all cases, the numbers reported for both groups were relatively close to one another on the 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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NCT00294671 · results posted 17 March 2017
According to the results reported on ClinicalTrials.gov, this trial enrolled 130 people with a hereditary nerve disease called Familial Amyloid Polyneuropathy — 64 received a medicine called diflunisal and 66 received a placebo (a dummy treatment with no active ingredient). The trial ran for two years and was measuring how much nerve damage progressed in each group, along with changes in body weight and nutrition, and self-reported quality of life. Of those who started, 37 in the diflunisal group and 26 in the placebo group completed the full two years. The reported data shows that the main measure of nerve damage — a scoring scale called NIS+7, where higher numbers mean worse nerve function — changed by an average of 8.2 points in the diflunisal group compared to 26.3 points in the placebo group over the two years. A second nerve-function score (the Kumamoto scale, where higher means worse) changed by an average of 3.1 points versus 8.0 points respectively. A measure combining body weight and a blood protein (used as a nutrition marker) fell by an average of 33.7 units in the diflunisal group and 67.9 units in the placebo group — a larger drop suggesting greater nutritional decline in the placebo group, though the data as reported does not allow further conclusions. For quality-of-life scores (rated 0–100, where lower is worse), the physical component changed by +1.2 in the diflunisal group and −4.9 in the placebo group, while the mental component changed by +3.5 versus −0.9. All figures above are as submitted by the trial sponsor; some detail on how these numbers were calculated was not reported in the structured 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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NCT02809911 · results posted 13 February 2017
According to the results reported on ClinicalTrials.gov, this trial involved 41 people in total — 22 in the sham (inactive/dummy device) group and 19 in the active Provant therapy device group. All 41 participants completed the study with no drop-outs. The trial was measuring how sensitive participants were to various types of experimentally caused pain — such as pressure, heat, cold, and mechanical stimulation — in both the upper body (arms and hands) and lower body (legs), comparing readings before and after a single treatment session with the device. The reported data shows that for the upper extremity (arm and hand) measurements, out of 20 different pain tests, 14 results pointed in the direction that favoured the active Provant group, while 6 pointed in the direction that favoured the sham group. For the lower extremity (leg) measurements, the pattern was reversed — out of the same 20 tests, 16 results pointed in the direction that favoured the sham group, while only 4 favoured the active Provant group. In simple terms, the two body regions produced quite different patterns of results between the groups. It is worth noting that the data submitted does not include further detail about the size of the differences seen in each individual test, 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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NCT01996410 · results posted 21 November 2016
According to the results reported on ClinicalTrials.gov, this trial looked at whether acupuncture might affect symptoms experienced by people undergoing chemotherapy. Symptoms were tracked using a tool called the MD Anderson Symptom Inventory (MDASI), which asks patients to rate 13 common symptoms such as pain, fatigue, and nausea. Participants were split into two broad groups — those who received acupuncture alongside their chemotherapy, and those who received standard care without acupuncture. The trial included eight sub-groups based on the type of chemotherapy received, though only four of those sub-groups actually enrolled anyone. The reported data shows that a total of 10 people took part in the trial — 6 in the acupuncture group (3 receiving one type of chemotherapy and 3 receiving another) and 4 in the no-acupuncture group (2 receiving one type of chemotherapy and 2 receiving another). All 10 participants who started the trial also completed it. No participants were enrolled in the sub-groups labelled "Chemotherapy 3" or "Chemotherapy 4" in either the acupuncture or the no-acupuncture arm. The reported data shows that no numerical results for the primary outcome measure — the MDASI symptom scores — were submitted to ClinicalTrials.gov. While the trial described how it planned to analyse and compare symptom scores between the two groups over time, the actual measurements were not reported in the structured results data available. This means it is not possible to describe what the symptom scores showed for either 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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NCT01454401 · results posted 6 October 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a treatment called LeucoPatch for diabetic foot ulcers — open sores on the feet that can occur in people living with diabetes. A total of 44 people started the trial, 39 completed it, and 5 did not finish. The trial was measuring how many participants' ulcers reached complete closure (where new skin had fully grown over the wound) within two different timeframes: 12 weeks and 20 weeks. The reported data shows that when looking at ulcer closure within 20 weeks (the main outcome the trial was designed to measure), 23 out of 44 participants were recorded as achieving complete wound closure. For the earlier 12-week timepoint (a secondary, or additional, outcome), 15 out of 44 participants were recorded as achieving complete wound closure. It is worth noting that the data as submitted appears to list the same participant numbers twice for each timeframe — likely representing two different analysis groups — however, as only one figure is clearly distinguishable for each timepoint, no further breakdown between those groups can be reported here without risk of misrepresenting the data. It is also important to note that this trial had no comparison group, meaning there was no separate group of participants receiving a different treatment or no treatment to compare these numbers against. This means the reported figures describe what was observed in this group 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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NCT01564459 · results posted 10 August 2016
According to the results reported on ClinicalTrials.gov, this trial investigated a drug called MK-6096 (taken as a 10 mg daily dose) in people with pain. The trial had two main stages: an open-label "run-in" period where everyone received MK-6096, followed by a double-blind period (meaning neither participants nor researchers knew who was getting what) where participants received either MK-6096 or a placebo (a dummy treatment with no active ingredient). A total of 182 people entered the double-blind stage — 87 continued on MK-6096 and 83 received placebo. The trial measured how long it took for the treatment to stop being effective (called "time to efficacy failure"), as well as changes in participants' self-reported pain scores on a scale of 0 (no pain) to 10 (worst imaginable pain). It also tracked how many participants experienced any unwanted health changes (called adverse events) during the study. The reported data shows that for the two main pain-related measures — how long it took for the treatment to stop working, both for those who responded strongly and those who responded moderately — no numerical results were reported in the data submitted to ClinicalTrials.gov. For the pain score change measures, among participants who responded most strongly to MK-6096 during the run-in, those who continued on MK-6096 had an average change of −0.104 points on the pain scale by the end of the double-blind period, while those switched to placebo had an average change of +0.482 points (meaning a slight increase). Among all responders, the MK-6096 group showed an average change of −0.318 points and the placebo group showed +0.368 points. Regarding adverse events, the reported data shows that during the run-in period, 24.7% of participants experienced at least one adverse event; during the double-blind period, 23.9% of those on MK-6096 and 13.4% of those on placebo experienced at least one adverse event. The proportions who stopped the study due to an adverse event were 3.8% during run-in, 0% in the MK-6096 double-blind group, and 1.2% 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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NCT02616523 · results posted 11 July 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT02616523) enrolled 60 people in total, split evenly into three groups of 20: one group received dexmedetomidine, one received lidocaine, and one received a placebo (an inactive substance used for comparison). The trial was measuring how much of a painkilling medicine called fentanyl was used during a surgical procedure, as well as how much of another painkiller (piritramide) was used afterwards in the recovery room, and whether participants reported nerve-related pain two months after surgery. One person in the dexmedetomidine group did not complete the trial; all others finished. The reported data shows that during the procedure, the dexmedetomidine group used an average of 41 micrograms of fentanyl, the lidocaine group used 50 micrograms, and the placebo group used 58 micrograms. In the recovery room, the reported data shows piritramide use was 4.63 mg in the dexmedetomidine group, 5.25 mg in the lidocaine group, and 4.25 mg in the placebo group. Two months after surgery, participants filled in a nerve-pain questionnaire scored from 0 to 10 (where a score of 4 or above suggests nerve-related pain may be present). The reported average scores were 0.11 for the dexmedetomidine group, 0.00 for the lidocaine group, and 0.45 for the placebo group — all well below the threshold of 4. Data for the complication outcome (such as constipation after surgery) 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT01987219 · results posted 2 June 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT01987219) enrolled 15 people in total across six groups, each receiving the treatments — albuterol (a common reliever inhaler), ipratropium bromide (another type of inhaler, sold as Atrovent), and a placebo (an inactive treatment) — in different orders. The trial was measuring changes in breathing function, specifically how much air participants could breathe out and how easily air moved through the airways. The reported data shows the following for the primary measures: the amount of air exhaled (forced vital capacity) changed by +5.5% from the starting point with albuterol, +4.7% with ipratropium bromide, and +0.9% with placebo. For airway resistance at a specific breathing frequency — essentially a measure of how much the airways were blocking airflow — the reported change was −22.7% with albuterol, −19.5% with ipratropium bromide, and −1.1% with placebo (a negative number here means less resistance, which is the direction of change being tracked). For the secondary measures, the volume of air breathed out in the first second changed by +7.69% with albuterol, +4.81% with ipratropium bromide, and −0.9% with placebo. A measure of airflow through the middle portion of a breath changed by +14.7% with albuterol, +11.5% with ipratropium bromide, and −2.99% with placebo. It is worth noting that only 15 people took part, which is a very small number, and one person did not complete 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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NCT02301169 · results posted 16 May 2016
According to the results reported on ClinicalTrials.gov, this trial (NCT02301169) enrolled 42 people in total — 21 in the T4P1001 group and 21 in the placebo (dummy treatment) group. One person in the T4P1001 group did not complete the trial; all 21 placebo participants finished. The trial was measuring changes in pain scores over four weeks, using several different pain rating scales where participants rated their pain from 0 (no pain) to 10 (the worst pain imaginable). Lower numbers on these scales represent less pain. The reported data shows the following changes from the start of the trial to the end of the four-week treatment period. For the main (primary) measure — average daily pain scores — the T4P1001 group reported a change of 0.87 points and the placebo group reported a change of 0.50 points on the 0–10 scale. For worst daily pain scores, the reported changes were 0.78 points (T4P1001) and 0.65 points (placebo). For a pain assessment carried out by the investigating doctor (rated 0–10, where lower is better), the reported changes were −0.15 points (T4P1001) and −0.95 points (placebo). For pain felt in response to heat stimuli in the clinic, the reported changes were 0.76 points (T4P1001) and −0.01 points (placebo). For the Brief Pain Inventory — a broader pain questionnaire also scored 0–10 — the reported changes were 3.35 points (T4P1001) and 1.67 points (placebo). The reported data does not include information explaining the direction (increase or decrease) for all measures, so readers should note that the context for each number as an improvement or worsening is not fully clear from 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.
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NCT01592344 · results posted 14 March 2016
According to the results reported on ClinicalTrials.gov, this trial looked at a device called the StimRouter, which delivers mild electrical stimulation to nerves under the skin as a way of managing ongoing pain. A total of 94 people took part — 45 in the active stimulation group and 49 in a control group (who received a non-active version of the treatment). The trial's main goal was to measure how many people in each group experienced a meaningful reduction in their resting pain — defined as a drop of 30% or more on a standard 0–10 pain rating scale, where 0 means no pain and 10 means the worst pain imaginable. The reported data shows that, for the primary (main) outcome, 17 out of 45 participants in the active stimulation group reached that 30%-or-greater pain reduction, compared with 5 out of 49 in the control group. For the secondary (additional) outcomes, the reported data shows that participants in the active stimulation group rated their overall impression of change at an average of 4.8 out of 7 (where higher numbers indicate greater improvement), compared with 2.5 in the control group. When looking at worst pain in the last 24 hours, the active stimulation group reported an average decrease of 2.4 points on the 0–10 scale from the start of the study to three months, while the control group reported an average decrease of 0.3 points. Satisfaction with the device was rated an average of 7.3 out of 10 in the active stimulation group, compared with 3.0 out of 10 in the control 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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NCT01270828 · results posted 13 January 2016
According to the results reported on ClinicalTrials.gov, this trial involved a medicine called pregabalin controlled release (CR) and was studying nerve pain. The trial ran in two stages. First, 806 people took an open-label (single-blind) phase where everyone received pregabalin CR to see how they responded. Of those, 660 completed that stage, and 413 people who responded well were then randomly placed into a second, double-blind phase — meaning neither the participants nor the researchers knew who was getting the real medicine. In this second stage, 208 people continued on pregabalin CR and 205 people were switched to a placebo (a dummy treatment with no active ingredient). The main thing the trial was measuring was how many people in each group lost their pain relief during the double-blind phase. The reported data shows that in the double-blind phase, 29 out of 208 participants in the pregabalin CR group were recorded as having lost their pain relief, compared with 63 out of 205 participants in the placebo group. For a secondary measure using a slightly different method of tracking pain over five days, the reported numbers were 49 participants in the pregabalin CR group and 87 in the placebo group. The reported data also shows that, at the end of the double-blind phase, 95.6% of the pregabalin CR group and 83.8% of the placebo group had at least a 30% reduction in pain scores compared to their starting point. For a 50% reduction in pain, the figures reported were 88.3% in the pregabalin CR group and 68.6% in the placebo group. Pain was rated on a scale of 0 (no pain) to 10 (worst possible pain); the average change in weekly pain score from the start of the double-blind phase to its end was reported as −0.04 for the pregabalin CR group and +0.87 for the placebo group, meaning pain scores on average stayed about the same in one group and rose slightly 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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NCT00829387 · results posted 18 June 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people in total — 23 in a behavioural group (which received a type of talking therapy known as Cognitive Behavioural Therapy, or CBT) and 24 in an educational group. By the end of the study, 20 and 21 participants had completed each group respectively, with three people in each group not finishing. The trial was measuring changes in pain intensity, how much pain interfered with daily life, and depressive symptoms, comparing the two groups at two points in time: 12 weeks and 36 weeks after the study began. The reported data shows the following numbers for pain intensity, rated on a scale of 0 (no pain) to 10 (worst imaginable pain). At 12 weeks, the behavioural group's average score changed by −0.83 (meaning it was slightly lower than at the start), while the educational group's changed by −0.45. At 36 weeks, both groups showed very similar changes: −0.87 for the behavioural group and −0.89 for the educational group. For how much pain interfered with daily activities (scored 0 to 6, where higher means more interference), the reported changes at 12 weeks were −0.03 for the behavioural group and +0.31 for the educational group; at 36 weeks, these were +0.06 and +0.99 respectively. For depressive symptoms (scored 0 to 63, where higher means more symptoms), the reported changes at 12 weeks were −0.35 for the behavioural group and +2.00 for the educational group; at 36 weeks, the reported figures were +0.077 for the behavioural group and +4.92 for the educational group. A negative number in all these cases means scores were lower than at the start, while a positive number means scores were higher than at the start. 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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NCT00471445 · results posted 10 June 2015
According to the results reported on ClinicalTrials.gov, this trial involved 462 people — 229 who used a cream containing amitriptyline and ketamine hydrochloride, and 233 who used a placebo (dummy) cream that contained no active ingredients. All participants were cancer survivors who had finished chemotherapy at least one month earlier and were experiencing chemotherapy-induced peripheral neuropathy — a condition involving pain, numbness, or tingling in the hands and feet — rated at 4 or higher on a scale of 0 to 10. The trial ran for 6 weeks and the main thing being measured was whether that pain, numbness, or tingling score changed over that time. The reported data shows that at the start of the trial, both groups had very similar average symptom scores: 6.55 out of 10 for the active cream group and 6.47 out of 10 for the placebo cream group. After 6 weeks, both scores had gone down — the active cream group's average score dropped to 4.93, and the placebo cream group's average score dropped to 5.19. In other words, both groups reported a reduction in their symptoms over the 6-week period, with the active cream group dropping by about 1.62 points and the placebo group dropping by about 1.28 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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NCT00270842 · results posted 8 April 2015
According to the results reported on ClinicalTrials.gov, this trial involved 101 older adults who were divided into three groups: an Education Control Group (33 people), a Functional Balance Training group (34 people), and a Tai Chi group (34 people). The trial was measuring balance, gait, and confidence in avoiding falls. Of those who started, 18 people in each group completed the study, meaning roughly half of the participants in each group did not finish. The reported data shows that the primary outcome — balance performance — was measured using the Berg Balance Scale, a 14-task test scored from 0 to 56, where higher numbers mean better balance. At the end of the study, the Education Control Group scored 51.3, the Functional Balance Training group scored 51.2, and the Tai Chi group scored 52.3. All three scores were relatively close together near the top of the scale. The reported data also shows a secondary outcome measuring how confident participants felt about carrying out everyday activities without falling, using a scale from 0 to 140 where higher scores mean greater confidence. The Education Control Group scored 121.5, the Functional Balance Training group scored 113.7, and the Tai Chi group scored 123.1. Again, all three groups returned scores that were broadly similar and toward the higher end of the scale. It is worth noting that the data as submitted does not include information about whether any differences between the groups were considered meaningful by the researchers. 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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NCT01013792 · results posted 23 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people in total — 14 in a group using a non-adherent wound dressing and 16 in a group using a dressing called Tegaderm Matrix with PHI Technology. All participants had diabetic foot ulcers. The trial was measuring how much the ulcer area changed over around 8 weeks of treatment, comparing the two types of dressings. Not everyone finished the study — 12 people completed it in the first group and 11 in the second group. The reported data shows that the primary outcome was the percentage change in ulcer size from the start of the trial to the last treatment visit. A positive number means the ulcer area got smaller compared to the starting size, while a negative number would mean it got larger. According to the results reported on ClinicalTrials.gov, the non-adherent dressing group showed an average reduction of 18.1% in ulcer area, while the Tegaderm Matrix with PHI Technology group showed an average reduction of 34.2% in ulcer area. No secondary outcome data appears to have been 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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NCT01533428 · results posted 13 March 2015
According to the results reported on ClinicalTrials.gov, this trial enrolled 369 adults in total — 186 received a single application of a capsaicin 8% patch (a patch containing a high concentration of the chilli-pepper-derived compound capsaicin) and 183 received a placebo (dummy) patch. The vast majority completed the study: 177 in the capsaicin group and 175 in the placebo group. The trial was measuring changes in daily pain scores in people with nerve pain caused by diabetes, using a scale from 0 (no pain) to 10 (worst imaginable pain), over a 12-week follow-up period. The reported data shows that, looking at the main outcome — average pain score change between weeks 2 and 8 — the capsaicin group reported a reduction of about 27%, while the placebo group reported a reduction of about 21%. For the period between weeks 2 and 12, the reported figures were similar: around 28% reduction in the capsaicin group and 21% in the placebo group. Both groups started with average pain scores of roughly 6.6 (capsaicin) and 6.4 (placebo) out of 10 at the beginning of the study. When looking at how many participants reported at least a 30% drop in their pain score between weeks 2 and 8, the reported data shows 74% in the capsaicin group compared with 60% in the placebo group; for a 50% drop over the same period, the figures were 39% and 33% respectively. Similar patterns were reported for the weeks 2–12 timeframe. 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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NCT02101294 · results posted 29 September 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people who had symptoms of carpal tunnel syndrome (CTS) — a condition involving pain, numbness or tingling in the hand and wrist. Twenty of them completed the study, while 11 did not finish. The trial was testing two different keyboard setups: a standard QWERTY keyboard and a keyboard called "FingerRelief." The main thing being measured was how long participants could type on each keyboard before noticing a change in their CTS symptoms. Wrist swelling (measured with a tape measure before and after typing) was also recorded. The reported data shows that, on average, participants typed for about 71 minutes on the standard QWERTY keyboard before experiencing a change in symptoms, compared to about 98 minutes on the FingerRelief keyboard. For wrist swelling, the reported data shows an average increase of 0.56 centimetres after typing on the QWERTY keyboard, and an average increase of 0.042 centimetres after typing on the FingerRelief keyboard. These are the numbers as submitted by the study sponsor — no other outcome figures were included in the reported data. It is worth noting that this trial had only one group of participants, meaning everyone used both keyboards rather than being split into separate groups for comparison. The trial was measuring differences in typing time and wrist swelling between the two keyboard types within the same 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.
View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
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NCT00782340 · results posted 16 May 2014
According to the results reported on ClinicalTrials.gov, this trial involved 263 people who started an initial open-label phase (where everyone received the study drug, droxidopa, to find the right dose). Of those, 162 went on to a second phase where they were randomly assigned — without knowing which they received — to either continue droxidopa (82 people) or switch to a placebo (an inactive dummy treatment, 80 people). The trial was measuring symptoms of orthostatic hypotension, a condition where blood pressure drops when a person stands up, causing dizziness and other problems. Participants rated their symptoms using a questionnaire scored from 0 (no symptoms) to 10 (worst possible), covering things like dizziness, fatigue, weakness, and how much difficulty they had standing or walking. The reported data shows that for the main outcome — an overall symptom score combining both how people felt and how symptoms affected daily activities — scores fell by 1.83 points on average in the droxidopa group and by 0.93 points in the placebo group from the point of randomisation (lower scores indicate fewer symptoms). For daily activity-related symptoms specifically, the reported average change was −1.98 for droxidopa and −0.92 for placebo. For general symptoms such as dizziness and fatigue, the reported average change was −1.68 for droxidopa and −0.95 for placebo. Looking at the individual symptom of dizziness, lightheadedness, or feeling faint, the reported change was −2.4 for droxidopa and −1.1 for placebo. Changes in activities involving standing for a short time were −1.9 (droxidopa) versus −0.8 (placebo), and for walking a short time, −1.7 versus −0.6. Notably, both groups showed some reduction in scores during this phase, including 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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NCT00738062 · results posted 16 May 2014
According to the results reported on ClinicalTrials.gov, this trial involved 103 people who had a condition called orthostatic hypotension — a drop in blood pressure when standing up that can cause dizziness, fainting, and difficulty with everyday activities. The trial first gave all participants an open-label treatment (droxidopa, meaning everyone knew what they were receiving) for about three months. Those who responded were then randomly split into two groups for a two-week phase: 38 continued on droxidopa and 37 were switched to a placebo (a dummy treatment with no active ingredient), without either the participants or researchers knowing who received which. The trial was measuring changes in symptoms and daily activity limitations using a questionnaire scored from 0 to 10, where higher numbers mean more severe problems. The reported data shows that during the two-week double-blind phase, both groups showed some worsening of symptoms compared to where they were at the start of that phase (when everyone had been on droxidopa). On the main measure — a combined symptom and daily activity score — the droxidopa group's score changed by +0.57 and the placebo group's score changed by +0.90 (on a 0–10 scale, where a higher positive number means greater worsening). For the daily activities sub-score, the reported changes were +0.53 (droxidopa) versus +0.71 (placebo). For the symptoms sub-score, the changes were +0.59 (droxidopa) versus +1.10 (placebo). The reported data also shows a difference in standing blood pressure: the droxidopa group's reading dropped by 8.4 mmHg (millimetres of mercury, a standard unit for blood pressure), while the placebo group's reading showed no change. For a separate measure asking patients to rate the overall severity of their condition on a 1–7 scale, the reported data shows that at the end of the double-blind period, 13 droxidopa and 12 placebo participants rated themselves in the mildest category, 16 droxidopa and 13 placebo participants in the middle category, and 9 droxidopa and 12 placebo participants in the most severe 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.
Read the full trial page · View reported results on ClinicalTrials.gov ↗
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NCT00536744 · results posted 14 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 206 people with diabetic foot ulcers (wounds on the feet related to diabetes). Participants were split into two groups: 107 people received the dermaPACE device — which uses sound wave energy — alongside standard wound care, while 99 people received an inactive (non-energised) version of the device alongside the same standard wound care. The trial's main goal was to measure how many people in each group had their wound completely close over 12 weeks. The reported data shows that, at the 12-week mark, 22 out of 107 participants in the dermaPACE group had complete wound closure, compared with 15 out of 99 participants in the inactive device group. In everyday terms, that is roughly 1 in 5 people in the active group and about 1 in 7 people in the inactive group whose wounds were reported as fully closed by that point. It is worth noting that not everyone finished the trial — 29 people in the dermaPACE group and 28 in the inactive group did not complete it, and the reasons were not detailed in the data provided here. The trial also planned to look at secondary measures such as how long it took for wounds to close, changes in wound size and depth, and participants' own ratings of their pain over 24 weeks. The reported data shows that no numerical results for these secondary outcomes were 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.
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NCT00060008 · results posted 4 April 2014
According to the results reported on ClinicalTrials.gov, this trial enrolled 18 participants, all of whom completed the study (none dropped out). The trial was looking at brain tumours, and was measuring whether a type of scan — an 18FDG-PET scan combined with MR perfusion imaging — could be used to track how a tumour changed in size over the course of one year. Specifically, the study examined whether a measurement from the PET scan (called SUVmax, which is essentially a score reflecting how much of a tracer substance the tumour absorbed) was linked to how much the tumour grew or changed over time. The reported data shows that participants were divided into two groups based on their SUVmax score — those with a score below 2, and those with a score above 2. In the group with an SUVmax score below 2, the reported average change in tumour size over the year was 4%. In the group with an SUVmax score above 2, the reported average change in tumour size was 27%. These figures represent the percentage change in tumour area and volume as measured over the follow-up period. It is worth noting that this was a small study involving only 18 people, and the results as submitted cover only this single outcome measure — no secondary outcome data appears to have been reported on ClinicalTrials.gov for this 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.
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NCT00573261 · results posted 18 July 2013
According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people with diabetes and peripheral neuropathy (nerve damage in the limbs) — 20 in a placebo group and 20 in a pregabalin group. The trial was measuring several things: changes in resting blood pressure, heart rate, heart rate variability (small natural beat-to-beat changes in the heart's rhythm, which can reflect how well the nervous system is working), and self-reported pain levels. Of the 40 who started, 29 completed the study — 14 in the placebo group and 15 in the pregabalin group. The reported data shows the following changes from the start of the trial to the end. For blood pressure, both groups showed a reduction; the placebo group's systolic (top number) pressure changed by −7.63 mmHg and the pregabalin group's by −8.98 mmHg, while diastolic (bottom number) pressure changed by −4.41 mmHg and −4.93 mmHg respectively. For heart rate, the placebo group changed by −2.94 beats per minute and the pregabalin group by −3.49 beats per minute. The heart rate variability measurements (recorded using a sensor vest called the LifeShirt) showed a range of changes across different technical frequency and timing measures in both groups; the reported numbers varied in direction and size between the two groups across these different measures. For pain — assessed using three different questionnaires scored on numerical scales — the reported data shows the pregabalin group had larger reductions in scores across all pain measures compared to the placebo group. For example, on the Visual Analog Scale (0–100, where higher means more pain), the placebo group's score changed by −21.29 points and the pregabalin group's by −43.27 points. Similar patterns of larger reductions in the pregabalin group were reported across the other pain scales, though the placebo group also showed reductions on most 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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NCT01089556 · results posted 4 December 2012
According to the results reported on ClinicalTrials.gov, this trial enrolled 811 people in total across two study periods. In the first period (weeks 1–8), around 404 participants were given duloxetine and 407 were given pregabalin. Those who did not respond well enough to their first medicine were then moved into a second period (weeks 9–16), where they were split into groups that either switched to the other medicine alone, or had the second medicine added on top of the first, creating a combination. The trial was primarily measuring changes in self-reported pain scores — specifically, how much a person's average pain over the previous 24 hours changed on a scale from 0 (no pain) to 10 (worst imaginable pain). The reported data shows that during the first period, the average pain score fell by about 2.3 points in the duloxetine group and about 1.7 points in the pregabalin group, from whenever they started. Also in that first period, about 52% of people on duloxetine and about 37% of people on pregabalin reported at least a 30% reduction in their average pain score, and about 40% on duloxetine and 28% on pregabalin reported at least a 50% reduction. For the main (primary) outcome measured at the end of the second period, the reported data shows an additional average drop in pain score of about 2.4 points in the combination group and about 2.2 points in the single-medicine (monotherapy) group. For the worst pain score over 24 hours, both the combination and single-medicine groups reported an almost identical additional drop of approximately 2.4 points. Regarding the proportion of people reaching at least a 30% reduction in average pain by week 16, the reported figures were about 62% in the combination group and about 56% in the single-medicine 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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NCT00021541 · results posted 17 September 2012
According to the results reported on ClinicalTrials.gov, this trial involved 62 children and young people in total — 31 in each group. It used a "crossover" design, meaning participants were assigned to receive either tipifarnib (the drug being studied) or a placebo (an inactive treatment) first, then switched to the other. The trial was looking at a condition involving tumours that could be tracked on MRI scans. The main things being measured were how long it took for the tumours to grow (called "time to progression"), how many participants experienced adverse events (unwanted health effects), and quality of life as reported by parents. The reported data shows that, for the primary measure of time to progression — based on MRI volume measurements — the tipifarnib group had a median (the middle value in the set of results) of 10.6 months in one period and 19.2 months in the crossover period. The placebo group had a median of 14.5 months in one period and 13.3 months in the crossover period. Of the 62 participants, 59 were reported as having experienced at least one adverse event, though the specific details of those events are listed separately in the trial record and are not reproduced here. For quality of life, parents rated their children on a scale of 1 to 5 (where higher scores mean better quality of life). The reported data shows scores of 3.69 (tipifarnib) and 3.70 (placebo) in one period, and 3.91 (tipifarnib) and 3.68 (placebo) in the crossover period — all sitting in a similar range. An additional measure using a different method reported a median time to progression of 52.5 months for the tipifarnib group; the equivalent figure using another method was not 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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NCT00863057 · results posted 25 April 2012
According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning each participant tried more than one treatment combination in sequence — involving 15 people in total across four groups. The trial was investigating pain related to nerve damage (neuropathy), and it compared four combinations: duloxetine plus methadone, duloxetine plus a methadone placebo (dummy pill), a duloxetine placebo plus methadone, and both placebos together. Participants rated their pain each day using a zero-to-ten scale (where 0 meant no pain and 10 meant the worst imaginable pain), and the main thing being measured was their average weekly pain score. The reported data shows that average weekly pain scores at the end of each treatment period were: 5.20 for those on both active medicines, 5.91 for duloxetine with methadone placebo, 6.20 for duloxetine placebo with methadone, and 5.70 for both placebos. For nighttime pain specifically, the reported scores followed a similar pattern: 5.20, 5.82, 5.90, and 6.10 respectively. When looking at how many participants achieved at least a 30% reduction in pain from their starting score, the reported data shows 2 participants in each of the four groups reached that threshold. For a 50% or greater reduction, 2 participants were reported in three of the groups, and 1 participant in the duloxetine-placebo-plus-methadone group. A measure of how much pain interfered with daily life (scored 0–10 across seven activities) was reported as 3.14, 4.14, 3.64, and 3.14 for the four groups. Quality-of-life data was not reported, as the trial noted a problem with the software needed to calculate those 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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NCT00533351 · results posted 19 January 2012
According to the results reported on ClinicalTrials.gov, this trial involved a small number of participants who were assigned to receive either a treatment called AGN201781 or a placebo (a dummy treatment with no active ingredient), in a crossover design — meaning people swapped between the two at different stages. The trial was set up to measure changes in daily pain scores and participants' own sense of how their pain had changed over a two-week treatment period. In total, 9 people started the first period of the trial (7 in one group and 2 in the other), and by the later periods, only a small handful remained. The reported data shows that, due to the very low number of participants who completed the treatment period, no formal analysis was carried out for either the primary outcome (change in daily pain score, measured on a scale from 0 to 10) or the secondary outcome (participants' own rating of overall change in their pain, measured on a 7-point scale). In other words, no numerical results were available to report for either measure. Because so few people finished the study, the trial was not able to produce the kind of data it was designed to generate, and no conclusions about the treatment's effects can be drawn from these 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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NCT00321672 · results posted 14 June 2011
According to the results reported on ClinicalTrials.gov, this trial looked at a skin patch treatment called NGX-4010 for nerve pain related to HIV. A total of 494 people took part across four groups: some received the NGX-4010 patch applied for 60 minutes, some received a control patch (a lower-strength comparison patch) for 60 minutes, some received the NGX-4010 patch for 30 minutes, and some received the control patch for 30 minutes. The trial ran for 12 weeks, and participants rated their pain each day on a scale of 0 to 10, where 0 means no pain and 10 means the worst possible pain. The reported data shows that, looking at percentage change in average daily pain scores from the start of the study through to weeks 2–12, the NGX-4010 60-minute group reported a reduction of about 32.8%, compared with 30.0% in the control 60-minute group. The NGX-4010 30-minute group reported a reduction of about 26.2%, compared with 19.1% in the control 30-minute group. In terms of actual points on the 0–10 pain scale, the reported data shows reductions of around 2.0 points for NGX-4010 at 60 minutes and 1.8 points for the control at 60 minutes, and 1.6 points versus 1.1 points for the 30-minute groups respectively. A secondary measure looked at how many participants reached at least a 30% drop in their pain scores: the reported figures were 48% for NGX-4010 at 60 minutes versus 45% for the control at 60 minutes, and 39% versus 26% for the 30-minute 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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NCT00654940 · results posted 24 February 2010
According to the results reported on ClinicalTrials.gov, this trial involved 25 people in total (13 in one group and 12 in the other). It was a "crossover" trial, meaning every participant took both the medicine being studied — pregabalin — and a dummy pill (placebo) at different times, with a two-week break in between. The trial was measuring pain levels in people with a type of nerve-related pain, using a simple 0–10 self-rating scale (where 0 means no pain and 10 means the worst pain imaginable). By the end of the trial, 23 participants had completed both periods. The reported data shows that at the start of each treatment period, average pain scores across the groups ranged from roughly 5.2 to 6.0 out of 10. After two weeks on pregabalin, the reported change in pain scores was a reduction of approximately 0.63 points (in Period 1) and 0.93 points (in Period 2). After two weeks on the placebo, the reported changes were a reduction of 0.16 points (in Period 1) and a small increase of 0.16 points (in Period 2). For the secondary pain questionnaire (a broader nerve-pain symptom survey scored out of 100), scores at the end of treatment ranged from approximately 3.0 to 5.3 across the different groups and timepoints. The reported data also shows that total physical activity counts during the day were approximately 300,000 for the pregabalin group and 270,000 for the placebo group, though the trial did not define a maximum possible score for 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.
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NCT00570310 · results posted 5 February 2010
According to the results reported on ClinicalTrials.gov, this trial involved 104 people in total — 53 were given pregabalin and 51 were given a placebo (a dummy treatment with no active ingredient). The trial was looking at pain intensity in people who had already been taking pregabalin during an open-label phase, and then were randomly assigned to either continue on pregabalin or switch to placebo without knowing which they received. The main thing being measured was how much their self-reported evening pain scores changed during this double-blind period. The reported data shows that pain intensity was rated on a scale of 0 to 10, where 0 means no pain and 10 means the worst pain imaginable. For the primary measure — the change in pain scores from before the double-blind period to the end of it — the pregabalin group showed an average change of 0.14 points, while the placebo group showed an average change of 1.57 points. For the secondary measure, the trial tracked how many days it took before a participant's pain reached a level that was considered a "treatment failure" (pain score of 4 or more, with at least a 30% increase from their starting point). The reported data shows the pregabalin group reached that point at an average of about 15.5 days, compared to about 7.9 days for the placebo group. It is worth noting that not everyone completed the trial — 2 people in the pregabalin group and 6 in the placebo group did not finish. 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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NCT00380874 · results posted 17 April 2009
According to the results reported on ClinicalTrials.gov, this trial enrolled 61 people in total — 32 were assigned to take pregabalin and 29 received a placebo (a dummy pill with no active ingredient). By the end of the study, 19 people in each group had completed it. The trial was looking at nerve-related symptoms — specifically tingling/pins-and-needles (paresthesia), abnormal skin sensations (dysesthesia), and pain — that can occur during chemotherapy treatment. Symptoms were tracked using a rating scale from 0 (no symptom) to 10 (worst possible), and the main question was whether pregabalin made any difference to these scores compared to the placebo. The reported data shows that for the primary outcome — an overall measure of tingling/pins-and-needles symptoms across the whole chemotherapy course — the pregabalin group had an average score change of 1.11 and the placebo group had a score change of 1.27. Both numbers represent how much symptoms changed from the starting point, averaged over time. The reported data also shows that across individual chemotherapy cycles, scores for tingling, abnormal sensations, and pain generally increased over time in both groups, with the numbers varying from cycle to cycle. For example, by cycle 5, the pain score change in the pregabalin group was reported as 0.85 compared to 0.31 in the placebo group. The number of participants reporting ongoing symptoms at the end of the study was also recorded, with small and similar counts across both groups for most symptom 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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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.