Reported trial results for Epilepsy

Every Epilepsy 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.

136 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

NCT03678753 · results posted 2 July 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT03678753) enrolled 169 people with a type of epilepsy that causes generalised tonic-clonic seizures (sometimes called "grand mal" seizures). Participants were randomly assigned to receive either cenobamate (85 people) or a placebo — a dummy treatment with no active ingredient (84 people). The trial was measuring changes in how often these seizures occurred during the treatment period compared to before the trial began. The reported data shows the following numbers. For participants in the USA and the rest of the world, those taking cenobamate had an average reduction in seizure frequency of about 72%, while those on placebo had an average reduction of about 40% — both figures measured against each person's own baseline seizure rate before the study. For participants in Europe, South Africa, Australia, and New Zealand (the region most relevant to an Australian audience), the trial measured how many people had at least a 50% drop in seizure frequency during the maintenance phase (the stable dosing period). The reported data shows 24 out of 59 cenobamate participants (roughly 41%) met this threshold, compared with 38 out of 40 placebo participants (roughly 95%) — noting these numbers as submitted to the registry. For secondary measures, the reported data shows that 36 of 47 cenobamate participants and 16 of 62 placebo participants achieved a complete (100%) reduction in these seizures during the maintenance phase; 46 of 37 cenobamate and 28 of 50 placebo participants achieved at least a 75% reduction; and 51 of 32 cenobamate and 34 of 44 placebo participants achieved at least a 50% reduction across all generalised seizure types. It should be noted that some of these figures appear internally inconsistent in the submitted data, and where that is the case, the numbers have been reported here exactly as submitted without 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.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT05163314 · results posted 9 June 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05163314) enrolled 352 participants who received a drug called soticlestat as part of a long-term open-label extension study — meaning all participants knew they were receiving the treatment. The trial was tracking a range of safety-related measures over time, including any unwanted medical events that occurred after starting the drug, thoughts of self-harm or suicide (using a standardised questionnaire called the Columbia-Suicide Severity Rating Scale), changes in body weight and height, stages of puberty development in children aged 6 to 17, and levels of a growth-related hormone called IGF-1 in children aged 2 to 17. Notably, the reported data shows that none of the 352 participants were recorded as having "completed" the study under the trial's own definitions, though the data below still reflects measurements taken during the study period. The reported data shows that out of 352 participants, 293 experienced at least one treatment-emergent adverse event — that is, an unwanted medical occurrence that began or got worse after the first dose of the study drug. Regarding the suicide and self-harm questionnaire, the large majority of participants at each time point were recorded in the category of "no suicidal ideation or behaviour," with small numbers (ranging from 1 to 3 participants at various time points) recorded in categories relating to suicidal thoughts or self-injurious behaviour. For body measurements in children, the reported data shows a range of changes in weight (roughly 2.85 kg to 11.10 kg across different time points and age groups) and height (roughly 9.50 cm to 16.47 cm), though the data does not clearly separate how much of this reflects normal childhood growth versus any effect of the drug. IGF-1 levels and puberty staging figures across age and sex groups were also reported, with values varying across age brackets, but the data was not reported in a way that allows straightforward before-and-after comparison for all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05301894 · results posted 13 February 2026

According to the results reported on ClinicalTrials.gov, this trial (NCT05301894) enrolled 19 participants, all of whom received at least one dose of the study drug, NBI-827104. No participants were recorded as having completed the study, meaning all 19 did not finish — though the data does not explain why. The trial was focused on tracking serious unwanted health events (called "serious treatment-emergent adverse events") that either appeared or got worse after participants started taking the study drug. The reported data shows that the primary thing being measured was how many participants experienced these serious unwanted health events during the study. Out of the 19 participants, 2 were reported as having experienced a serious treatment-emergent adverse event. No other outcome measures 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.

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NCT05218655 · results posted 22 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05218655) enrolled 101 participants who all received at least one dose of a medicine called vatiquinone. The trial had one single group — meaning all participants received the same treatment, with no comparison group. The main thing the trial was set up to measure was how many participants experienced "treatment-emergent adverse events" (TEAEs) — that is, any unwanted medical occurrence that happened after taking the study drug and within 30 days of the last dose. The reported data shows that out of 101 participants, 91 experienced at least one such adverse event during the study period. It is worth noting that the trial records show zero participants listed as having "completed" the study, with all 101 recorded as "not completed" — however, the data does not explain the reason for this, and no further outcome measures beyond this single count were reported in the structured results submitted to ClinicalTrials.gov. It is also important to note that recording an adverse event does not on its own indicate whether the medicine caused it — it simply means the event occurred during the study window. No secondary outcome measure data was reported in the structured results available, 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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NCT04686786 · results posted 11 December 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04686786) enrolled 105 participants, all of whom received at least one dose of the study drug, CVL-865 at 25 mg. The trial was an open-label study — meaning all participants knew what they were taking — and it was primarily focused on tracking safety-related measurements, including unwanted medical events (called adverse events), heart rhythm readings, vital signs like blood pressure and heart rate, physical and neurological check-ups, and any signs of suicidal thoughts. Thirty-nine participants completed the study, while 66 did not finish. The reported data shows that out of 105 participants, 88 experienced at least one treatment-emergent adverse event (an unwanted medical event that occurred after starting the study drug), and 11 experienced a serious adverse event (a more severe event such as hospitalisation or a life-threatening occurrence). For heart rhythm, zero participants showed clinically significant changes in their ECG readings. Two participants had clinically significant changes in vital signs such as blood pressure or heart rate. For physical and neurological examinations, the data reported 5 participants with significant physical changes and 7 with significant neurological changes. Regarding suicidal thoughts, as measured by a structured rating scale (the C-SSRS), the reported figures were 6, 5, 1, 2, and 0 participants across the scale's different severity categories — though the data as submitted does not label which number corresponds to which specific category. Finally, a measure of withdrawal symptoms (scored from 1 to 68, where higher means more severe) showed an average change of −1.4 points from the end of treatment to the end of the follow-up period at week 61, meaning the average score was slightly lower at follow-up than at the end of 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 ↗
NCT04519645 · results posted 3 October 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04519645) involved newborns experiencing seizures and compared two approaches: a medicine called lacosamide and an active comparator (an existing seizure medicine). A small number of participants also had a "no treatment" observation period, though this group did not continue into the main treatment phase. In total, around 26 newborns received treatment — approximately 14 in the lacosamide group and 12 in the active comparator group. The trial's main goal was to measure how much seizure activity (recorded in minutes of seizures per hour on a specialised brain-monitoring test called a video-EEG) changed between a baseline recording before treatment and a follow-up recording one to three hours after the first dose. The reported data shows that, for the primary measure, seizure activity appeared to change by an average of 6.64 minutes per hour in the lacosamide group and 2.45 minutes per hour in the active comparator group — where a higher positive number means a greater reduction from baseline. For secondary measures, the reported data shows that around 60% of participants in the lacosamide group and about 67% in the active comparator group met the trial's definition of a "responder" (meaning a meaningful reduction in seizure activity without needing rescue medication). When looking specifically at those who achieved an 80% or greater reduction in seizure activity, the reported figures were 60% for lacosamide and 44% for the active comparator. The reported median time to first response was 3 hours in both groups, while the reported median time to complete freedom from seizures was 3 hours for lacosamide and 8 hours for the active comparator. The reported data also shows that, when seizure activity was tracked across the full 48-hour treatment period, both groups showed reductions from baseline at most time points measured, with the lacosamide group generally showing larger reported reductions at each time point. It is important to note that this was a very small trial, and the numbers above simply describe what was recorded and reported — they do not on their own tell us whether one approach is better than another. 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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NCT04325282 · results posted 4 September 2025

According to the results reported on ClinicalTrials.gov, this trial involved 22 children diagnosed with a condition called SeLECTS (a type of childhood epilepsy). It used a "crossover" design, meaning each child received both a real version and a fake (sham) version of a brain stimulation treatment called repetitive transcranial magnetic stimulation (rTMS) — with a one-week rest period in between. The trial was measuring two things: the frequency of abnormal brain activity bursts seen on a brain wave recording (called interictal epileptiform discharges, or IEDs), and how connected different regions of the brain were to each other before and after stimulation. Of the 22 children who started, 20 completed the full trial. The reported data shows that for the primary outcome — counting those abnormal brain activity bursts — the recorded values for both the real and sham stimulation sessions were reported as zero IEDs per five minutes. This likely reflects how the data was recorded or summarised in the submission, though the exact context for these zero values was not further explained in the structured data. For the secondary outcome measuring brain connectivity, the reported data shows that after real (active) rTMS, connectivity scores across six brain region pairs ranged from approximately −0.016 to −0.039 (meaning connectivity appeared to decrease slightly), while after sham rTMS, the same measurements ranged from approximately +0.001 to +0.015 (meaning connectivity appeared to stay roughly the same or increase very slightly). These connectivity scores are measured on a scale from 0 to 1, so all the changes reported were quite small in absolute terms. 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 ↗
NCT03355209 · results posted 3 July 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03355209) enrolled 296 participants across two groups — Cohort A (the larger group, with around 87 people per arm) and Cohort B (a smaller group, with around 11 people per arm). The trial was testing a medicine called ZX008 (fenfluramine) at two different daily doses — 0.2 mg/kg/day and 0.8 mg/kg/day — compared to a placebo (a dummy treatment with no active ingredient), in people with Lennox-Gastaut syndrome, a type of epilepsy that causes "drop seizures" (seizures that make a person suddenly fall or drop). The trial had two parts: a blinded period where neither participants nor doctors knew who received which treatment, followed by an open-label extension where everyone knew the treatment being given. The reported data shows that during the blinded period (Part 1), the average percentage change in drop seizure frequency compared to before the trial started was: in Cohort A, the placebo group had a 7.59% reduction, the 0.2 mg/kg/day group had a 14.16% reduction, and the 0.8 mg/kg/day group had a 26.49% reduction. In Cohort B, the placebo group showed a 17.89% reduction, the 0.2 mg/kg/day group showed a 14.12% reduction, and the 0.8 mg/kg/day group showed a 34.52% reduction. As a secondary measure, the proportion of participants whose drop seizures fell by at least half ranged from about 10% in placebo groups up to about 36% in some ZX008 groups. On a doctor-rated improvement scale, the proportion rated as at least "minimally improved" ranged from roughly 10–34% in placebo groups to as high as 73% in one ZX008 group. During the open-label extension period (Part 2), the reported data shows that 83.0% of Cohort A participants and 96.9% of Cohort B participants experienced at least one adverse event (an unwanted or unexpected medical occurrence recorded during the study). Serious adverse events — those considered medically significant, requiring hospitalisation, or life-threatening — were reported in 16.6% of Cohort A and 18.8% of Cohort B participants during this period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05769634 · results posted 26 June 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05769634) enrolled 20 participants, all of whom completed the study with no drop-outs. The trial was looking at something called the "Heartbeat Evoked Potential" (HEP) — a tiny electrical signal measured in the brain that is timed to each heartbeat. Researchers believe this signal reflects how the brain picks up on signals from the heart. The study used an "Interoceptive Challenge Battery," which is a set of tasks designed to test how the brain and body sense internal physical states. The trial measured changes in this brain signal in relation to two things: attention and arousal (how alert or activated a person feels). The reported data shows that, on average, the HEP signal changed by **−1.5 µV** (microvolts — a very small unit of electrical activity) when measured in relation to attention, and by **−2.02 µV** when measured in relation to arousal. Both figures represent the average change in the brain signal after participants went through the experimental tasks. No standard deviation or confidence interval figures (which would show how spread out the results were across participants) were included in the submitted data, so those details are not available to report 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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NCT04244175 · results posted 30 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04244175) enrolled 154 people in total across three groups: 51 received a placebo (a dummy treatment with no active ingredient), 51 received a lower dose of CVL-865 (7.5 mg taken twice daily), and 52 received a higher dose of CVL-865 (25 mg taken twice daily). The trial was measuring changes in the frequency of focal onset seizures — a type of seizure that starts in one part of the brain — during a treatment period compared to a baseline period recorded before treatment began. The reported data shows the main outcome was a score called the "Response Ratio," where a negative number means seizures happened less often during treatment than before it. The placebo group scored −24.06, the lower-dose CVL-865 group scored −22.45, and the higher-dose CVL-865 group scored −25.90. For the secondary outcomes, the reported percentage change in weekly seizure frequency from baseline was −26.2% for placebo, −27.2% for the lower dose, and −29.8% for the higher dose. When looking at who had their seizures cut by at least half, the reported data shows 30.0% of the placebo group, 34.8% of the lower-dose group, and 38.3% of the higher-dose group reached that mark. Complete freedom from seizures during the treatment period was reported for 6.0% of the placebo group, 2.2% of the lower-dose group, and 4.3% of the higher-dose group. Participants also rated their own sense of overall change on a 1–7 scale (where lower numbers mean feeling more improved); average scores across the groups were broadly similar, ranging from around 3.0 to 3.5 across time points and 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 ↗
NCT04391569 · results posted 29 May 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04391569) enrolled 100 people in total — 51 received a medicine called ganaxolone and 49 received a placebo (a dummy treatment with no active ingredient). The trial was looking at people experiencing status epilepticus, a serious condition where seizures do not stop on their own. The study measured whether ganaxolone could stop seizures within 30 minutes without needing extra seizure medicines, whether it prevented the need for strong anaesthetic drugs given through a drip, and what unwanted medical events occurred during the trial. The reported data shows that among those who received ganaxolone, about 80% had their seizures stop within 30 minutes without needing additional seizure medicines, compared with about 13% in the placebo group. For the question of whether participants avoided needing anaesthetic drugs through a drip in the 36 hours after treatment started, the reported figures were about 63% in the ganaxolone group and about 51% in the placebo group. Looking further out to 72 hours, the reported data shows roughly 51% of the ganaxolone group and 47% of the placebo group did not progress to needing those anaesthetic drugs. The reported median time for seizures to stop was around 0.07 hours (just over 4 minutes) in the ganaxolone group and 2.85 hours in the placebo group. Regarding treatment escalation in the first 24 hours, about 55% of the ganaxolone group needed additional seizure medicines compared with about 81% of the placebo group. On unwanted medical events, 48 out of 51 participants in the ganaxolone group and 43 out of 49 in the placebo group experienced at least one such event during the study period; further breakdowns were reported but individual category labels were not fully included in 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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NCT04912856 · results posted 14 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT04912856) involved 8 children in total — 5 who had previously received the study drug XEN496 in an earlier trial, and 3 who had previously received a placebo (a dummy treatment with no active ingredient). The trial was measuring the safety and tolerability of XEN496 by tracking how many participants experienced adverse events (unexpected or unwanted health occurrences) and serious adverse events (more significant health occurrences) during the study period. The reported data shows that across both groups, all 8 participants who started the study experienced at least one adverse event — all 5 in the prior-XEN496 group and all 3 in the prior-placebo group. When it came to serious adverse events, 1 participant in the prior-XEN496 group and 2 in the prior-placebo group were reported to have experienced one. No deaths were reported in either group. Regarding study completion, only 1 participant from the prior-XEN496 group completed the study, while no participants in the prior-placebo group completed it — meaning the large majority (4 and 3 respectively) did not finish the trial, though the reasons for this are 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.

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NCT05288283 · results posted 3 February 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT05288283) was studying a medicine called GWP42003-P (a cannabidiol-based treatment) compared to a placebo (an inactive dummy treatment) in people with a type of epilepsy called Epilepsy with Myoclonic-Atonic Seizures (EMAS), which causes several kinds of seizures including drop attacks. The trial had two parts: Part A aimed to measure whether seizure frequency changed over a 14-week treatment period, and Part B aimed to record any notable changes in participants' health checks, such as vital signs, physical examinations, heart tracings (ECGs), and laboratory tests. According to the data submitted, only 1 participant was enrolled in each group (GWP42003-P and placebo), and neither participant completed the study. The reported data shows that no numerical results were provided for any of the outcome measures — neither the seizure frequency data from Part A, nor any of the health monitoring results from Part B. This means that, while the outcomes being measured are listed, no actual figures or findings were submitted to ClinicalTrials.gov for this trial. Given that no participants completed the study and only one person was enrolled per group, it appears the trial did not generate enough data to report 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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NCT03443388 · results posted 9 January 2025

According to the results reported on ClinicalTrials.gov, this trial (NCT03443388) tested a deployable helmet device designed to protect people with epilepsy from head injuries during seizures. The study ran in two parts. Part 1 involved 4 participants and tested whether the helmet deployed successfully during a staged (controlled) fall. Part 2 then involved a further 5 participants split across two groups — some wore the helmet first and then did not wear it, while others did the reverse — to see how the helmet performed during real-life seizures. In total, 9 people started the trial and 8 completed it; one person in Part 2 did not finish. The reported data shows that in Part 1, all 4 staged falls resulted in a successful helmet deployment (the pre-set target was 3 out of 4), which allowed the study to move to Part 2. For Part 2, the trial used questionnaires and medical record reviews to compare experiences between participants who were wearing the helmet during a seizure and those who were not. One secondary measure used was the Rivermead Post-Concussive Scale, a questionnaire about head-injury-related symptoms scored from 0 to 72 (where a lower number means fewer symptoms compared to before the fall). The reported data shows an average score of 0 for participants who wore the helmet during Part 2, and an average score of 21.5 for those who were not wearing the helmet — however, given the very small number of participants involved, these figures should be interpreted with great caution, and the data for several other questionnaire items was not fully broken down in the submitted results. It is also important to note that this was a very small, early-stage trial, and the reported numbers reflect the experiences of only a handful of individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗
NCT04940624 · results posted 1 January 2025

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called soticlestat compared to a placebo (a dummy treatment with no active ingredient) in people with a serious form of epilepsy. A total of 144 people took part — 71 in the placebo group and 73 in the soticlestat group. The trial measured how often participants experienced convulsive seizures (seizures involving shaking or loss of muscle control) over the course of the study, and whether the number of those seizures changed compared to before the trial started. The reported data shows that, on average, the placebo group had about an 8.6% reduction in convulsive seizures across the full treatment period, while the soticlestat group had about a 22.2% reduction. During a specific later phase called the "maintenance period," the placebo group showed roughly a 12% reduction and the soticlestat group showed roughly a 23.3% reduction. The reported data also shows that when looking at participants who had at least a 50% drop in their seizure rate — described in the trial as "responders" — about 9.9% of the placebo group met this threshold across the full treatment period, compared to about 27.4% of the soticlestat group. Caregivers were also asked to rate overall impressions of change; in the soticlestat group, about 4.5% rated the participant as "very much improved" and 27.3% as "much improved," compared to 1.5% and 11.8% respectively 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.

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NCT04387435 · results posted 28 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04387435) enrolled only one participant in the intervention arm. The study was measuring two things: changes in seizure frequency or duration (the primary focus), and changes in heart rate and blood pressure during specific physical tests — such as tilting upright, deep breathing, a breathing-pressure exercise called the Valsalva manoeuvre, and a cold stimulus test (the secondary focus). The reported data shows that the single participant who started the trial did not complete it. Because of this, no measurement results were recorded or submitted for either the primary outcome (seizure frequency or duration) or the secondary outcome (heart rate and blood pressure responses). In other words, the data fields for both outcomes are empty — no numbers were reported. Given that only one person was enrolled and that person did not finish the trial, the results as submitted contain no findings to describe beyond participation numbers. The data was not reported for any of the outcome measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04639310 · results posted 23 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04639310) enrolled a small number of children with a rare genetic epilepsy condition called KCNQ2-DEE. Eight participants took part in total — five received the investigational medicine XEN496 and three received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in how often children experienced certain types of seizures, using diaries kept by parents and caregivers over a treatment period of roughly 15 weeks. The reported data shows that, for the main thing being measured — the percentage change in monthly seizure frequency compared to the start of the trial — the XEN496 group showed an average reduction of 46%, while the placebo group showed an average increase of 25.6%. For one of the secondary measures, 2 out of 5 participants in the XEN496 group had their monthly seizures cut by at least half, compared to 0 out of 3 in the placebo group. Caregiver questionnaires asking about overall condition and seizure severity showed mixed and limited results across both groups, with only small numbers of participants showing improvement on any individual measure. Because the numbers involved are very small, the reported data also notes figures related to adverse events (unwanted health changes noticed during the trial), though the full breakdown of those events was not reported in a way that allows plain description beyond the participant counts provided. It is worth noting that with only 8 participants total, this was a very small trial, and the reported numbers on ClinicalTrials.gov reflect that limited scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT04938427 · results posted 21 August 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT04938427) enrolled 270 people in total — 136 in the placebo group and 134 in the soticlestat group. The trial was studying a medicine called soticlestat in people who experience "major motor drop" seizures (a type of seizure where the body suddenly loses muscle control and the person drops). The main thing being measured was whether the number of these seizures per 28 days changed from the start of the trial to during treatment. The reported data shows that, when looking at the full treatment period, the placebo group had an average reduction in seizure frequency of about 6.7%, while the soticlestat group had an average reduction of about 6.1%. During a later "maintenance" phase of the trial, the placebo group showed an average reduction of about 9.6%, compared to about 5.2% in the soticlestat group. For a secondary measure — the proportion of participants whose seizures fell by 50% or more during the maintenance period — the reported data shows 11.4% of the placebo group met this threshold compared with 19.4% of the soticlestat group. Caregivers were also asked to rate overall impressions of change; the reported data shows that during the full treatment period, roughly 22% of caregivers in the placebo group and approximately 22% in the soticlestat group rated the participant as "much improved" or "very much improved," with the remaining spread across categories from "minimally improved" through to "much worse." It is worth noting that more participants in the soticlestat group did not complete the trial (20 out of 134) compared with the placebo group (10 out of 136), though the reasons for this were not detailed in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT05201703 · results posted 31 July 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of participants — just 4 people in total. They were split into two groups: one person received a daily dose of 4 mg of Fycompa (a seizure medication), and three people received 4 mg daily with the option to increase to 6 mg daily. The trial was measuring what is called a "responder rate" — that is, how many participants experienced at least a 50% reduction in the number of seizures they had, compared to before the study started. The reported data shows that by the end of the study, only 2 of the 4 participants had completed the trial. Of those who did not complete it, none were in the 4 mg-only group, while 2 were in the group that could receive up to 6 mg. For the primary outcome — the number of participants who had a 50% or greater drop in seizures — the reported data shows 1 participant in each group met that threshold. No other outcome measures were reported in the submitted data. It is worth noting that with only 4 participants enrolled overall, this is an extremely small number, and no further detail about safety or other measures was included in the submitted results. The reported data shows only the raw counts of participants who responded, without additional context or analysis being 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.

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NCT02535091 · results posted 14 May 2024

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,340 people in total across three groups: 83 people taking YKP3089 (now known as cenobamate) alongside a medicine called phenytoin, 37 people taking it alongside phenobarbital, and 1,220 people taking it alongside other epilepsy medicines. The trial was primarily measuring how many participants experienced side effects (called treatment-emergent adverse events) during the study. Relatively few participants completed the study — 22, 5, and 236 people in each group respectively — while the majority did not finish. The reported data shows that, when it came to side effects, 76 out of 83 people in the phenytoin group, 35 out of 37 in the phenobarbital group, and 1,104 out of 1,220 in the other epilepsy medicines group experienced at least one side effect during the study period. Serious side effects were recorded in 9, 6, and 168 people across the three groups respectively, and side effects that led to stopping the study medication occurred in 57, 29, and 923 people respectively. The reported data also shows that participants took the study medicine for roughly 28–30 months on average, and that the most commonly taken daily dose was around 183–244 mg depending on the group. The reported data also includes measurements of the drug's level in participants' blood at various points during the study, which ranged roughly between 11.8 and 16.5 micrograms per millilitre (a unit measuring how much of the medicine was present in the blood) across the different groups and time points. Information on abnormal vital signs such as blood pressure and pulse was also collected, with 64 out of the total safety population of participants recording at least one abnormal reading after starting the study medicine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03785028 · results posted 1 May 2024

According to the results reported on ClinicalTrials.gov, this trial (NCT03785028) enrolled 5 participants, all in a single experimental group, and all 5 completed the study. The trial was measuring brain activity patterns in people who had electrodes placed on or in their brains (a method called electrocorticography, typically used in certain medical procedures). Researchers were looking at how the brain holds and prioritises different types of memories — such as faces, scenes, and words — during a short-term memory task, and how brain signal patterns change depending on which memory item is considered more important at any given moment. The reported data shows results across three main areas of measurement. For the first primary outcome, a computer-based analysis (called a Support Vector Machine, which is a tool that tries to identify patterns in data) was used to detect whether brain signals could distinguish which memory item a person was holding in mind. The results were reported as simple yes (1) or no (0) values across four types of brain wave frequencies — Theta, Alpha, Beta, and Gamma — for both prioritised and unprioritised memory items. For the second primary outcome, the reported data shows how a particular type of brain signal relationship (called phase-amplitude coupling, meaning how slower and faster brain rhythms interact) changed — either increasing or decreasing — across three brain regions (Left Hippocampus, Right Post Temporoparietal area, and Inferior Temporal Cortex) for faces, scenes, and words. These too were reported as simple counts or directional values. For the third primary outcome, relating to how the brain responds to shifts in spatial attention, the reported data shows no measurements were 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.

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NCT02408549 · results posted 14 December 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02408549) enrolled 239 participants, all of whom received the medication lacosamide. Of those, 157 completed the study and 82 did not. The trial was a long-term follow-on study that focused on monitoring unwanted events (called adverse events) that occurred during treatment, as well as tracking whether participants developed any new types of seizures — specifically absence seizures (brief "blank staring" episodes) or myoclonic seizures (sudden brief muscle jerks) — that they had not experienced before starting the medication. The reported data shows that out of 239 participants, 222 experienced at least one treatment-emergent adverse event (meaning an unwanted event that appeared or got worse after starting the medication). Of these, 19 participants withdrew from the study because of such events. Regarding new seizure types, the reported data shows that 3 participants developed new absence seizures and 5 developed new myoclonic seizures during the treatment period who had not had those seizure types before. The data also tracked whether absence seizures became more frequent compared to a pre-treatment baseline period: 5 participants showed an increase of up to 25% in days with absence seizures per 28 days, 1 participant showed an increase of more than 25% up to 50%, and no participants showed an increase of more than 50% up to 75%. Figures beyond that range 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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NCT05089682 · results posted 1 November 2023

According to the results reported on ClinicalTrials.gov, this trial looked at a Deep Brain Stimulation (DBS) system — a device implanted in the brain that delivers electrical signals — and how it related to sleep. Four people started the trial, two completed all scheduled activities, and two did not finish. Because this was a very small study, the numbers below describe the group's results overall rather than a large population. The reported data shows several sleep-related measurements taken across what appear to be different time points (though the trial did not label these time points by name in the submitted data). For total sleep time, the reported figures were approximately 497, 490, and 432.5 minutes across the three measurement points. The time it took participants to fall asleep was reported as 19, 14, and 9.5 minutes, while the time from falling asleep to reaching REM sleep (the deeper dreaming stage) was reported as 149, 114.5, and 76.5 minutes. Alertness was measured using the Karolinska Sleepiness Scale, a 1–9 rating where lower numbers mean feeling more alert — the reported scores were 3.83, 3.67, and 4.17. Reaction time was also measured in milliseconds (thousandths of a second), with reported values of 388.20, 422.83, and 392.72 milliseconds. It is worth noting that with only two people completing the study, these numbers come from a very small group and should be interpreted with that in mind. No comparison group (such as a placebo or control group) was 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.

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NCT02823145 · results posted 25 September 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02823145) was an open-label extension study involving 374 participants who received ZX008 (fenfluramine), a medication being studied for convulsive seizures. One additional participant was enrolled but did not receive treatment. The trial tracked what happened to participants over a long-term treatment period of up to 42 months, measuring both how often unwanted medical events occurred and how frequently participants experienced convulsive seizures (episodes involving shaking or jerking movements). The reported data shows that 98.1% of the 374 treated participants experienced at least one treatment-emergent adverse event — meaning an unwanted medical event that occurred after starting the study drug. Of those, 26.5% experienced a serious adverse event (defined as one involving hospitalisation, being life-threatening, causing significant disability, death, or another medically significant concern), and 3.5% had an adverse event serious enough to cause them to stop taking the study drug. Regarding seizure frequency, the reported data shows that among participants who had baseline data from earlier related studies, the average number of convulsive seizures per 28 days decreased by 6.67 from their original starting point when measured across the full treatment period, and by 7.04 when measured from Month 2 onwards. The reported seizure counts per 28 days across the treatment period ranged from around 6.53 in the earliest interval down to as low as 2.80 in later intervals, though it is important to note these are group averages and individual results varied. 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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NCT02914314 · results posted 15 September 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT02914314) looked at the drug perampanel in very young children with epilepsy, aged from 1 month up to 4 years old. A total of 21 children took part, divided into four age groups: 4 children aged 1 to 6 months, 5 children aged 6 to 12 months, 9 children aged 12 to 24 months, and 3 children aged 24 to 48 months. The trial ran in two parts — a core phase of up to 20 weeks, followed by an extension phase of up to a further 36 weeks. Because no primary outcome measure data was submitted to ClinicalTrials.gov for this trial, only secondary outcome data was reported. The reported data shows that the trial tracked adverse events (unexpected medical events that occurred during treatment) and serious adverse events (those involving hospitalisation, life-threatening situations, disability, or death). During the core phase, adverse events were recorded in 3 out of 4 children in the youngest age group, all 5 children in the 6–12 month group, all 9 children in the 12–24 month group, and all 3 children in the oldest group. Serious adverse events during the core phase were reported in 2 children in the youngest group, 1 in the 6–12 month group, 2 in the 12–24 month group, and 1 in the oldest group. The trial also measured various blood test values (such as blood cell counts and liver-related markers) over time. The reported data shows small numerical changes in these values across the age groups and between the two phases, though the figures varied from group to group; for example, average changes in haemoglobin (a measure in the blood) ranged from a small decrease of 0.25 units in one group to an increase of 14 units in another during the core phase. 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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NCT03154307 · results posted 23 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT03154307) was designed to look at the effects of repetitive transcranial magnetic stimulation (rTMS — a non-invasive brain stimulation technique) on epilepsy-related measures in people with seizures. The study had four planned groups: weekly rTMS, monthly rTMS, a sham (inactive/pretend) rTMS group, and a short-term protocol group. However, the reported data shows that only 2 participants were enrolled, both in the weekly rTMS group, and only 1 of those 2 completed the study. No participants were enrolled in any of the other three groups. The trial measured seizure frequency, seizure duration, and brain wave activity recorded by an EEG (a test that picks up electrical signals in the brain). The reported data shows the following numbers for the one participant in the weekly rTMS group who provided data: an average of 22 seizures per week was recorded; the number of abnormal electrical brain signals (called interictal discharges — brief bursts of unusual brain activity seen in people with epilepsy) was reported as 0 at the measurement point; and average seizure duration was approximately 34.5 seconds. For the secondary brain wave measures, a ratio of 0.45 was recorded for left-versus-right brain activity in the alpha frequency range, and standardised brain connectivity values of 0.4, 0.455, 0.375, and 0.255 were reported across four brain regions. No data was reported for the muscle response threshold measure. Because only one participant completed the trial, results from the other three groups were not reported, and the data as a whole is extremely limited in scope. 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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NCT00441896 · results posted 2 June 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT00441896) enrolled 57 infants and young children in total across five groups (called cohorts). Each cohort tested different doses or dosing schedules of an intravenous drug called ganaxolone compared to a placebo (an inactive substance). Participants were assigned to one of two sequences — either receiving ganaxolone first or placebo first — and then switched over the course of the study. The main thing being measured was how the number of "spasm clusters" (episodes of repeated muscle jerks) per day changed from the starting point to Day 10, as recorded by a specialised 24-hour brain-monitoring and video test. The reported data shows that changes in spasm cluster frequency at Day 10 varied widely across the different groups. In some groups that received ganaxolone first, the reported change was a reduction — for example, minus 5.4 spasm clusters per day in one cohort and minus 3.7 in another. In some placebo-first groups, reductions were also recorded, such as minus 5.3 and minus 1.0. In a couple of groups, the number actually went up slightly (for example, plus 1.0 and plus 0.2). A similar mixed picture was seen at Day 20, the secondary time point. For the other secondary measures, the reported data shows that across the ganaxolone-treated groups, between 1 and 3 participants per group were recorded as spasm-free at the monitoring points, and between 1 and 2 participants per group showed no abnormal brain-wave pattern (called hypsarrhythmia) on the brain monitor. On the doctors' and caregivers' overall rating scales, only 1 participant in two of the ganaxolone groups was noted as showing improvement, with zero recorded in most other groups. Two participants did not complete the study (one each from two different groups); reasons 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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NCT02519439 · results posted 14 February 2023

According to the results reported on ClinicalTrials.gov, this trial enrolled 26 people, all of whom received a medicine called ganaxolone. The trial was an open-label extension study, meaning all participants knew they were taking the medicine, and it followed on from an earlier trial. The main thing being measured was how much the frequency of seizures changed over time compared to where each person started (their "baseline"). Of the 26 people who started, only 5 completed the study, and 21 did not complete it. The reported data shows that, on average, participants experienced a 41.86% reduction in how often seizures occurred over a 28-day period compared to their starting point. For the secondary measures, the reported data shows that 14 out of 26 participants had their seizure frequency drop by 50% or more from their baseline. Clinicians also rated each participant's overall change using a standard 7-point scale (where 1 means "very much improved" and 7 means "very much worse"). At the end of treatment, 1 participant was rated "very much improved," 9 were "much improved," 11 were "minimally improved," 2 showed "no change," and none were rated as worse. When participants or their carers rated their own impression using a similar 7-point scale, 4 rated themselves "very much improved," 8 "much improved," 10 "minimally improved," 1 "no change," and none rated themselves as worse. It is worth noting that the high number of people who did not finish the trial (21 out of 26) is an important feature of these results to be aware of, though the reasons were not detailed in the data 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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NCT01963208 · results posted 14 February 2023

According to the results reported on ClinicalTrials.gov, this trial (NCT01963208) looked at a medicine called ganaxolone compared to a placebo (a dummy treatment with no active ingredient) in people with epilepsy who experience ongoing seizures. The main group of interest (called Cohort 2) started with 179 people taking ganaxolone and 180 taking placebo during the first, blinded phase — meaning neither the participants nor the doctors knew who was getting which treatment. A smaller group (Cohort 1) included 24 on ganaxolone and 22 on placebo. The trial also included a later open-label phase (where everyone knew they were receiving ganaxolone), in which 158 and 173 participants started, though considerably fewer completed that longer phase. The reported data shows that the main thing being measured was how much seizure frequency changed from the starting point over the treatment period, expressed as a percentage. For Cohort 2, the ganaxolone group showed a reported reduction of around 21% in seizures per 28 days, compared to around 10% in the placebo group. As a secondary measure — looking at who had at least a 50% drop in seizure frequency — the reported data shows 50 out of 179 participants in the ganaxolone group reached that mark, compared to 39 out of 180 in the placebo group. The reported data also shows that the ganaxolone group gained roughly 1.47 more seizure-free days per 28-day period compared to their starting point, while the placebo group gained around 1.01 seizure-free days. In absolute numbers, the ganaxolone group had approximately 1.46 fewer seizures per 28 days from their starting point, versus 0.33 fewer 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.

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NCT03350035 · results posted 15 December 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03350035) looked at a drug called GNX given at three different dose levels — low, medium, and high — to people experiencing a serious type of prolonged seizure called Status Epilepticus (SE). A total of 17 people started the trial (5 in the low-dose group, 4 in the medium-dose group, and 8 in the high-dose group), and 14 completed it (3, 4, and 7 respectively). The trial was primarily measuring how many participants did not need to be given a stronger, intravenous (directly into the vein) anaesthetic drug to stop their seizures within the first 24 hours. The reported data shows that, for the primary measure, all participants who started the trial — 5 in the low-dose group, 4 in the medium-dose group, and 8 in the high-dose group — did not require that stronger intravenous anaesthetic drug during the first 24 hours. For the secondary measures, the reported data shows the time until seizures stopped was around 5 minutes for the low-dose group, approximately 5.6 minutes for the medium-dose group, and roughly 10.2 minutes for the high-dose group. The reported data also shows that the number of participants who needed no further increase in treatment for ongoing or returning seizures was 3 out of 5 (low dose), 3 out of 4 (medium dose), and 8 out of 8 (high dose). Seizure activity (referred to as "seizure burden") was also measured as a percentage change from the starting point, and the reported figures show reductions across all three groups and multiple time points, ranging from approximately −48% to −99%, though the data was not reported in a way that clearly links each figure to a specific time point for each 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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NCT01964560 · results posted 25 October 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT01964560) enrolled 540 people who were taking lacosamide, a medicine used for epilepsy. All 540 participants were treated as a single group. Of those who started the study, 395 completed it and 145 did not finish. The trial was measuring how often participants experienced unwanted medical events (called adverse events) while taking the medicine, as well as tracking how many of their days were free from seizures, based on diary records they kept themselves. The reported data shows that 77.2% of participants experienced at least one treatment-emergent adverse event — that is, an unwanted medical occurrence that began after starting the medicine or within 30 days of their last dose. Of all participants, 20.6% experienced a serious adverse event (meaning one that involved hospitalisation, was life-threatening, caused significant disability, or met other defined serious criteria). A smaller proportion — 4.1% — had an adverse event that led them to stop taking part in the study altogether. For the secondary outcome, the reported data shows that participants recorded an average of approximately 66.96% of their days as seizure-free, based on the daily diaries they completed during the treatment period. No other secondary outcome figures 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.

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NCT02682927 · results posted 19 October 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 262 participants across two separate studies (Study 1 and Study 3). The trial was measuring how a drug called ZX008 (given at two different daily doses — a lower dose of 0.2 mg/kg/day and a higher dose of 0.8 mg/kg/day) compared to a placebo (a dummy treatment with no active ingredient) in changing how often participants experienced convulsive seizures — that is, seizures involving physical movements such as jerking, stiffening, or falling. Seizure counts were tracked over 28-day periods using electronic diaries. The reported data shows that, for the main (primary) outcome — change in average monthly convulsive seizure count — participants in Study 1 who received the higher dose of ZX008 had a reported change of minus 13.11 seizures per 28 days from their starting point, compared to minus 6.71 for the placebo group. In Study 3, the higher dose group showed a change of minus 3.54 seizures per 28 days, while the placebo group showed a change of plus 1.54 (meaning that group's average count went slightly up). For the lower dose, Study 1 reported a change of minus 18.81 seizures per 28 days versus minus 6.71 for placebo, and Study 3 reported minus 5.89 versus plus 1.54. The reported data also shows the proportions of participants who saw large reductions in seizure frequency: for example, in Study 1, 67.5% of those on the higher dose and 38.5% on the lower dose were reported to have had at least a 50% reduction in seizures, compared to 12.5% in the placebo group. In Study 3, those figures were 72.9% and 45.7%, compared to 6.3% for placebo. Complete seizure freedom (100% reduction) was reported in 7.5% of the Study 1 higher-dose group and 12.5% of the Study 3 higher-dose group, with 0% in both placebo 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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NCT01364597 · results posted 29 August 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 257 children and teenagers with epilepsy, ranging in age from one month to under 17 years. They were divided into four age groups: 36 children aged one month to under two years, 15 aged two to under four years, 141 aged four to under 12 years, and 65 aged 12 to under 17 years. Some participants joined the trial directly, while others transferred in from a previous related study for longer-term follow-up. The trial was measuring how often participants experienced unwanted health events (called adverse events) after taking a medicine called brivaracetam (BRV), and also looked at whether seizure frequency changed over time. The reported data shows that across all four age groups, roughly 92–94% of participants experienced at least one unwanted health event after starting brivaracetam — specifically, 94.4% in the youngest group, 93.3% in the two-to-four-year group, 93.6% in the four-to-12-year group, and 92.3% in the 12-to-17-year group. Serious unwanted health events (those involving hospitalisation, life-threatening situations, or significant disability, among other criteria) were reported in 38.9% of the youngest group, 53.3% of the two-to-four-year group, 29.8% of the four-to-12-year group, and 29.2% of the oldest group. For the secondary measures, the reported data shows that in participants aged two years and older with a specific seizure type (partial-onset seizures), seizure frequency per 28 days changed by an average of –37.48 seizures (a reduction), representing a reported 26.57% change from their starting point. Around 50.9% of participants aged two years and older were recorded as having at least a 50% reduction in overall seizure frequency. For the youngest children (under two years), whose seizures were tracked differently using a brain-monitoring recording (EEG), the reported average daily seizure count changed by 2.56 seizures per day. 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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NCT03572933 · results posted 26 July 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT03572933) enrolled 101 people in total — 51 received a placebo (a dummy treatment with no active ingredient) and 50 received ganaxolone, a medicine being studied for a type of epilepsy involving major motor seizures (seizures that cause strong physical movements such as stiffening, jerking, or sudden falls). The trial compared how often these seizures occurred over a double-blind treatment period (meaning neither the participants nor the researchers knew who was receiving which treatment) relative to a six-week period of observation before treatment began. By the end, 47 placebo participants and 48 ganaxolone participants completed the study. The reported data shows that, when looking at the main (primary) outcome — the number of major motor seizures per 28 days — the placebo group started at a median of roughly 49 seizures per 28 days at baseline and this figure was around 56 during the treatment period. The ganaxolone group started at around 54 seizures per 28 days at baseline and this figure was around 45 during the treatment period. For the secondary outcomes, the percentage of days completely free of major motor seizures was reported as approximately 36% for the placebo group and 32% for the ganaxolone group during the treatment period. Caregivers and clinicians also rated changes in attention, behaviour, and overall impression of improvement on structured rating scales; the reported counts across the different rating categories are available in the full submission, but no single summary figure clearly favoured one group over the other in a straightforward way based on the numbers 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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NCT03603639 · results posted 4 May 2022

According to the results reported on ClinicalTrials.gov, this was a small crossover trial — meaning each participant tried all three treatments in a different order — involving just 6 people in total. The trial was testing a drug called E2730 (at two doses: 40 mg and 120 mg) compared to a placebo (an inactive treatment), in people whose brains show a particular type of abnormal electrical response when exposed to flashing lights, as measured by a brainwave test called an EEG. The main thing being measured was whether the doses of E2730 changed how sensitive participants were to flashing lights, using a scoring system called the Standard Photosensitivity Response (SPR), where a score of 0 means no sensitivity and 14 means sensitivity across the full range of tested flash rates — so lower scores represent less sensitivity. The reported data shows that at the start (baseline), the average SPR scores in the most sensitive eye-testing condition were 7.80 for the placebo group, 5.50 for the 40 mg group, and 9.00 for the 120 mg group. At 8 hours after taking the treatment, the reported average change from baseline was −0.12 (a very small decrease) for placebo, +0.65 for the 40 mg dose, and +1.00 for the 120 mg dose — meaning scores went slightly up across all groups on average. For the secondary outcomes looking at whether any individual participants showed a large enough reduction in their score to meet pre-defined thresholds for "complete suppression" or "partial response," the reported data shows that no participants in any group met the complete suppression definition, and only 1 participant (in the placebo group) met the partial response definition. The data for time-to-onset and duration of response were reported as "not available" — meaning those figures were 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.

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NCT01866111 · results posted 29 April 2022

According to the results reported on ClinicalTrials.gov, this trial (NCT01866111) looked at cenobamate, a medicine being studied for partial-onset seizures (a type of epileptic seizure that starts in one part of the brain). A total of 437 adults took part in the main double-blind phase, split into four groups: 108 received a placebo (a dummy treatment with no active ingredient), 108 received cenobamate at 100 mg per day, 110 received 200 mg per day, and 111 received 400 mg per day. The trial measured how much seizure frequency changed compared to before treatment began. A smaller (more negative) percentage means fewer seizures were recorded during the trial period. The reported data shows that, on average, the placebo group experienced a 24% reduction in seizures per 28 days from their starting point. The 100 mg cenobamate group showed a 35.5% reduction, while both the 200 mg and 400 mg groups each showed a 55% reduction. The trial also tracked the number of people whose seizures fell by at least half compared to their starting level — sometimes called a "50% responder." The reported data shows this occurred in 23 out of 108 people in the placebo group, 44 out of 108 in the 100 mg group, 63 out of 110 in the 200 mg group, and 67 out of 111 in the 400 mg group. It is worth noting that fewer participants completed the trial in the higher-dose groups — 81 of 111 finished in the 400 mg group compared with 94 of 108 in the placebo group — though the reasons for not completing were not detailed in the data 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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NCT02332655 · results posted 2 March 2022

According to the results reported on ClinicalTrials.gov, this trial enrolled 5 participants, all of whom received cannabidiol (CBD). Four participants completed the trial and one did not. The trial was measuring changes in how often seizures occurred each month, comparing a baseline period (the eight weeks before treatment began) to the point around week 14 of the study. Parents and caregivers kept daily seizure diaries throughout. The reported data shows the number of seizures per month for individual participants at baseline and then at week 14. The figures listed include baseline counts of 33.5, 30.0, 3.0, 0.5, and 3.0 seizures per month, and corresponding later counts of 2.0, 5.0, 0.5, and 1.0 seizures per month (noting that only four sets of follow-up figures appear, consistent with four completers). For the secondary outcome — the percentage change in seizure frequency between baseline and each participant's most recent visit — the reported data shows four individual figures: a 12% change, a 100% change, an 83% change, and a 64% change. The trial recorded positive values as a decrease in seizure frequency. No group-average (mean) figures were reported in the submitted data, so individual participant numbers are what is available. It is worth noting that this was a very small trial with only five participants, so the reported numbers reflect a narrow group of individuals. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02224573 · results posted 3 February 2022

According to the results reported on ClinicalTrials.gov, this was a long-term extension study involving people with two types of epilepsy: Dravet Syndrome and Lennox-Gastaut Syndrome. A total of 315 people with Dravet Syndrome and 366 people with Lennox-Gastaut Syndrome entered the treatment phase, making 681 participants in total. The study was measuring a range of health and safety-related observations over time, including unwanted health events (called adverse events), changes in body measurements, heart readings, thoughts about self-harm, and any symptoms that appeared when the study medication was gradually reduced at the end of the trial. The reported data shows that, when it came to unwanted health events occurring in at least 5% of participants, 306 out of 315 people in the Dravet Syndrome group and 353 out of 366 people in the Lennox-Gastaut Syndrome group experienced at least one such event during the treatment phase. For body mass index (a measure of body weight relative to height), the reported average change from the starting point was a small increase of 0.42 kg/m² in the Dravet Syndrome group and 0.05 kg/m² in the Lennox-Gastaut Syndrome group. Regarding thoughts about self-harm, assessed using a standardised questionnaire, very small numbers of participants — mostly 0, 1 or 2 per question — recorded responses indicating such thoughts in either group. When the medication was being tapered (gradually reduced) at the end of the study, withdrawal symptom scores on a scale of 0–190 were generally low across both groups at most time points, with the highest individual average score reported being 16.3 in the Dravet Syndrome group at one particular follow-up point. Several other detailed measurements around heart readings and vital signs were also reported, with the numbers of participants showing clinically notable changes varying across the different measures and groups; full details were recorded in the study 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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NCT03370120 · results posted 29 December 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03370120) enrolled 406 participants who were taking a drug called padsevonil, which was being investigated as a treatment for focal-onset seizures (a type of epilepsy where seizures start in one area of the brain). The trial was an extension study, meaning participants had already taken part in one of two earlier related trials. The study was measuring how often unwanted medical events (called adverse events) occurred, whether any of those events caused people to stop the study, and how seizure frequency changed compared to the start of those earlier trials. Notably, the reported data shows that none of the 406 participants formally completed the study. The reported data shows that 72.2% of participants experienced at least one treatment-emergent adverse event — meaning a medical occurrence that either appeared after starting the study drug or got worse after starting it. Of the 406 participants, 5.2% had an adverse event that led them to withdraw from the study entirely. For seizure frequency, the reported data shows an average change of minus 7.73 seizures per 28 days compared to the baseline recorded in the earlier parent studies, meaning the reported number of observable focal-onset seizures was lower on average during this study than at that earlier starting point. It is important to note that these numbers describe what was measured and recorded, not whether padsevonil caused any particular 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.

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NCT03739840 · results posted 25 October 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03739840) enrolled 232 adults across four groups to study a drug called padsevonil for focal-onset seizures (a type of epilepsy where seizures begin in one part of the brain). Participants were randomly assigned to receive either a placebo (a dummy treatment with no active ingredient) or one of three doses of padsevonil — 100 mg, 200 mg, or 400 mg, taken twice daily. The trial measured changes in seizure frequency over a 12-week period, as well as tracking unwanted medical events (called adverse events) that occurred during the study. The reported data shows that when looking at changes in seizure frequency (measured using a mathematical scale called log-transformed frequency, which adjusts the numbers to make them easier to compare statistically), all four groups showed a reduction from their starting point: the placebo group showed a change of -0.41, the 100 mg group -0.35, the 200 mg group -0.47, and the 400 mg group -0.47. Regarding participants who experienced at least a 50% reduction in seizures, the reported figures were: 27.8% in the placebo group, 35.6% in the 100 mg group, 33.9% in the 200 mg group, and 42.9% in the 400 mg group. For at least a 75% reduction, the figures were 13.0%, 15.3%, 12.5%, and 14.3% respectively. On unwanted medical events during the study period, the reported data shows that 69.1% of the placebo group experienced at least one such event, compared with 83.3%, 78.9%, and 84.7% in the three padsevonil dose groups. The percentage of participants who withdrew from the study due to an unwanted event was 7.3% (placebo), 10.0%, 10.5%, and 20.3% across the three padsevonil doses. Serious unwanted events were reported in 9.1% (placebo), 3.3%, 1.8%, and 10.2% of participants respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02351115 · results posted 10 August 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 5 participants, each of whom completed the study. It was a crossover trial, meaning each participant received all five treatments in a different order — an inhaled placebo, and three different doses of an inhaled form of alprazolam (0.5 mg, 1 mg, and 2 mg) delivered via a device called Staccato, plus one further sequence variation. The trial was primarily measuring changes in something called the Standardised Photosensitivity Range (SPR) — a way of counting how many light-flash frequencies triggered an abnormal brain wave response on an EEG (a brain activity recording). A reduction in that count was the desired direction for the measurement. The reported data shows that, on the primary measure, the placebo group had an average change of −0.2 frequency steps, while the three alprazolam dose groups showed larger reductions: −4.4 steps for the 0.5 mg dose, −5.2 steps for the 1 mg dose, and −4.8 steps for the 2 mg dose. On the secondary measures of self-reported drowsiness (rated on a 100-point scale), the reported data shows the placebo group changed by around −5 points on the "sedated-to-alert" scale, compared with changes of approximately −58, −67, and −71 points for the 0.5 mg, 1 mg, and 2 mg doses respectively. Similar patterns were reported on a separate "sleepy-to-awake" scale. The trial also reported figures examining the relationship between the amount of alprazolam measured in participants' blood and the size of these effects, though interpreting those statistical figures requires specialist knowledge. 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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NCT03428360 · results posted 5 August 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03428360) enrolled 130 people with epilepsy, of whom 90 completed the study and 40 did not finish. The trial was looking at a study drug delivered inside the cheek (the inner lining of the mouth), and it was primarily measuring what kinds of unwanted events (called adverse events) occurred after people took the drug, as well as how easy or difficult the packaging and delivery method were to use. The reported data shows that out of the 130 participants who received at least one dose, 84 experienced at least one unwanted event that started on or after taking the study drug. Regarding specific categories of events that researchers were watching closely: 32 participants reported events related to mouth or oral irritation (such as swelling, ulcers, or stinging), 3 reported events related to potential misuse or mood-related effects, and 8 reported breathing-related events, while 21 reported nervous system-related events. The remaining figures for this outcome measure were 1 and 8 participants respectively, though the data as submitted does not provide full labels for every individual sub-category figure beyond what is described above. On the usability side, the reported data shows that out of all recorded occasions when the drug was used, difficulty opening the outer plastic packaging was noted on 211 occasions. Difficulty opening the inner foil pouch was reported on 391 occasions, while no difficulty was reported on 957 occasions. Difficulty removing the drug from the foil pouch was noted on 47 occasions, compared with 1,301 occasions where no difficulty was reported. The drug was successfully placed and kept inside the cheek on 1,330 use occasions. 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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NCT02687711 · results posted 4 August 2021

According to the results reported on ClinicalTrials.gov, this trial enrolled 544 people who were taking a medicine called brivaracetam (BRV) for a type of epilepsy known as partial-onset seizures — seizures that start in one specific area of the brain. The main thing the trial was measuring was how many participants stayed on brivaracetam for a full 12 months. By the end of the study, 332 people had completed it, while 212 did not finish. The reported data shows that 57.7% of participants were still taking brivaracetam at the 12-month mark — this was the primary (main) measure the trial was designed to track. Looking at earlier time points, 82.4% were still on the treatment at 3 months, and 70.6% were still on it at 6 months. The trial also tracked how the number of seizures per 28 days changed compared to where participants started (their "baseline"). The reported data shows the average number of seizures per 28 days was lower than baseline by 4.54 seizures at 3 months, by 3.29 seizures at 6 months, and by 3.75 seizures at 12 months. These figures represent averages across those who remained in the study at each time point, and no comparison group (such as a placebo or dummy treatment group) was included in 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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NCT02201251 · results posted 17 May 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT02201251) compared two epilepsy medicines — topiramate and levetiracetam — in children and adolescents. A total of 28 participants started in the topiramate group and 35 in the levetiracetam group. The main thing the trial was measuring was how each medicine related to changes in body weight and height over time, using something called a "z-score." A z-score is simply a number that shows how a child's weight or height compares to what would be expected for children of the same age and sex in the general population — a score of zero means exactly average, a negative score means below average, and a positive score means above average. The reported data shows that both groups had small decreases in their weight z-scores over the 12 months of the study, but the decreases were larger in the topiramate group. For example, by month 12 the topiramate group's average weight z-score had shifted by −0.351, while the levetiracetam group's shifted by −0.065. At earlier time points the pattern was similar: at month 1 the changes were −0.112 (topiramate) and −0.014 (levetiracetam); at month 3, −0.201 versus −0.027; at month 6, −0.319 versus −0.070; and at month 9, −0.326 versus −0.110. For height at the one-month mark (the only height result reported in the submitted data), the topiramate group showed a change of +0.004 and the levetiracetam group −0.015. No further height z-score data at later time points 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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NCT03283371 · results posted 27 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03283371) looked at whether natalizumab 300 mg — given by infusion — could reduce seizure frequency in people with epilepsy, compared to a dummy treatment (placebo). A total of 67 people entered the first (placebo-controlled) part of the trial, with 34 assigned to placebo and 33 to natalizumab. After completing that phase, 61 participants moved into an open-label phase where everyone received natalizumab. The trial tracked seizures using a daily diary, focusing on certain seizure types over a roughly six-month period. The reported data shows that the primary measure — a mathematical score reflecting how much seizure frequency changed from the starting point during weeks 8 to 24 — shifted by −0.43 (in log units) in the placebo group and −0.58 (in log units) in the natalizumab group. Both numbers represent a reduction from baseline, and the values were relatively close to each other. For one of the secondary measures, 17.6% of placebo participants and 31.3% of natalizumab participants were counted as "responders," meaning they had at least a 50% drop in seizure frequency during that same period. On the question of being completely seizure-free during weeks 8 to 24, the reported data shows 1 participant in the placebo group and 0 in the natalizumab group met that definition. The reported data also shows that 6% of placebo participants and 3% of natalizumab participants were recorded as having an inadequate treatment response (such as withdrawing due to lack of benefit or needing a change in their other epilepsy medicines). Regarding adverse events (unexpected medical occurrences during the trial, which may or may not be related to the treatment), the reported data shows these were recorded in 22 of 34 placebo participants and 24 of 33 natalizumab participants during the placebo-controlled phase, with 1 serious adverse event in each group during that phase. In the open-label phase, serious adverse events were reported in 3 participants (those who switched from placebo to natalizumab) and 2 participants (those who continued on natalizumab). 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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NCT03694275 · results posted 20 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03694275) tested a medicine called soticlestat in two separate groups of children and adults with rare epilepsy conditions: 8 people with Dup15q syndrome and 12 people with CDKL5 deficiency disorder (CDD). All 8 participants in the Dup15q group finished the study, while 10 out of 12 in the CDD group completed it. The trial was primarily measuring whether the number of motor seizures (seizures involving physical movement) changed compared to each participant's starting level. The reported data shows that the two groups had notably different results on the main measure — the change in seizure frequency during the maintenance (later) phase of the trial. In the Dup15q group, the average seizure count went up by about 11.7% compared to where it started. In the CDD group, the average seizure count went down by about 23.6%. For a secondary measure looking at seizures lasting longer than 5 minutes in the CDD group, the reported data shows an average reduction of about 54%. When it came to the proportion of days completely free of motor seizures during the maintenance period, both groups reported the same figure of 0.1 days per 28 days, meaning seizure-free days were uncommon in both groups. On a clinician-rated severity scale (scored 1–7, where lower is better), both groups had an average starting score of 5.0, and the reported change from that starting point was 0.0 for both groups, meaning no average change was recorded on that 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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NCT03373383 · results posted 9 April 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03373383) enrolled 411 adults across five groups to study a medicine called padsevonil for focal-onset epilepsy (a type of epilepsy where seizures start in one part of the brain). One group received a dummy pill (placebo), while the other four received different twice-daily doses of padsevonil: 50 mg, 100 mg, 200 mg, or 400 mg. The trial ran for about 23 weeks in total, and the main things being measured were changes in how often participants had observable seizures over a 12-week period, as well as unwanted medical events (called adverse events) that occurred during the study. The reported data shows that when looking at seizure frequency, all five groups showed a reduction from their starting point during the 12-week maintenance period. The placebo group's change score was −0.28 (on a mathematical log scale used to compare across groups), while the padsevonil groups ranged from −0.41 to −0.49 on the same scale — meaning all groups, including placebo, recorded fewer seizures than at the start. For the secondary measure of how many participants had their seizures cut by at least 50%, the reported figures were: 21.0% in the placebo group, 33.8% (50 mg), 31.7% (100 mg), 25.9% (200 mg), and 32.1% (400 mg). For a 75% or greater reduction in seizures, the reported figures were 6.2% (placebo), 13.8% (50 mg), 12.2% (100 mg), 11.1% (200 mg), and 16.0% (400 mg). The reported data also shows that unwanted medical events of any kind were recorded in 78.3% of placebo participants, compared with figures ranging from 75.6% to 92.6% across the padsevonil dose groups. The percentage of participants who stopped the study because of an unwanted medical event was 8.4% in the placebo group, rising to 7.4%, 12.0%, 18.3%, and 25.9% across the four padsevonil doses respectively. Serious adverse events (those considered medically significant) were reported in 4.8% of the placebo group and between 4.8% and 7.4% across the padsevonil 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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NCT03650452 · results posted 18 February 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03650452) enrolled 141 people in total — 70 received a placebo (a dummy treatment with no active ingredient) and 71 received the investigational drug TAK-935. Participants had either Dravet syndrome or Lennox-Gastaut syndrome (LGS), both of which are types of epilepsy involving frequent seizures. The trial was measuring changes in how often seizures occurred compared to before treatment began. The reported data shows that, during the main measurement period (called the "maintenance period"), the placebo group experienced a small increase in seizure frequency of about 3%, while the TAK-935 group reported an average reduction of about 28%. Looking at each condition separately, the reported data shows that participants with Dravet syndrome in the TAK-935 group had an average reduction in convulsive seizures of around 37%, compared to an increase of about 9% in the placebo group. For participants with LGS, the TAK-935 group reported an average reduction in "drop seizures" (a type of seizure where the person suddenly falls) of about 18%, compared to a very small reduction of about 2% in the placebo group. The trial also looked at how many participants had their seizure frequency cut by at least half. In the Dravet syndrome group, this was reported for approximately 42% of TAK-935 participants compared to 0% in the placebo group. In the LGS group, it was reported for approximately 28% of TAK-935 participants compared to around 16% 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.

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NCT03478982 · results posted 3 February 2021

According to the results reported on ClinicalTrials.gov, this trial (NCT03478982) looked at a inhaled medication called Staccato Alprazolam (also called STAP-001) as a treatment for seizures. The trial enrolled 156 people across four groups: a small open-label group (where everyone knew what was being given) of 11 people receiving a 1.0 mg dose, and three double-blind groups (where neither participants nor doctors knew who received what) of 50 people given a placebo (dummy treatment), 47 given a 1.0 mg dose, and 48 given a 2.0 mg dose. Of those enrolled, some did not end up being treated, leaving 8, 40, 38, and 38 people respectively in what is called the "intent-to-treat" population — that is, the group whose results were analysed. The main thing the trial measured was the percentage of participants whose seizure activity stopped within 2 minutes of taking the study drug and did not return within 2 hours. The reported data shows that 62.5% of the open-label 1.0 mg group, 42.5% of the placebo group, 65.8% of the double-blind 1.0 mg group, and 65.8% of the double-blind 2.0 mg group met this measure. The trial also tracked several secondary measures. When participants rated how the seizure they had during the study compared to their usual seizures (on a scale where higher scores mean "better than usual"), the reported data shows that 12.5% of the open-label group, 42.5% of the placebo group, 57.9% of the 1.0 mg double-blind group, and 55.3% of the 2.0 mg double-blind group rated the seizure as better than their previous experience — though it should be noted that additional breakdown data across the full 5-point scale was only partially reported. Regarding the use of additional "rescue" medication to stop a seizure during the study, the reported figures were 0% in the open-label group, 7.5% in the placebo group, 15.8% in the 1.0 mg double-blind group, and 7.9% in the 2.0 mg double-blind group. Finally, the percentage of participants whose seizure spread to become a more serious type was reported as 12.5% in the open-label group and 0% across all three double-blind 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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NCT00088452 · results posted 14 October 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 453 children across three groups: 156 received ethosuximide, 149 received lamotrigine, and 148 received valproic acid. The trial was looking at treatments for childhood absence epilepsy — a condition involving brief, repeated "blank staring" episodes. The main thing being measured was how many children were free from "treatment failure" at around 16–20 weeks. Treatment failure meant the seizures continued, a different type of seizure occurred, or the child had to stop the medicine due to side effects or other problems. The reported data shows that at the 16–20 week mark, 81 out of 156 children in the ethosuximide group, 43 out of 149 in the lamotrigine group, and 85 out of 148 in the valproic acid group were recorded as free from treatment failure. At the 12-month mark, the reported numbers were 70 out of 156 for ethosuximide, 31 out of 149 for lamotrigine, and 64 out of 148 for valproic acid. The trial also measured attention difficulties using a standardised test (a tool that estimates the likelihood a child has attention problems), and reported that 35 children in the ethosuximide group, 25 in the lamotrigine group, and 52 in the valproic acid group scored at a level suggesting possible attention difficulties. 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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NCT02796924 · results posted 30 September 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 10 participants, all of whom completed the study — meaning no one dropped out. The trial was looking at people who experience psychogenic non-epileptic seizures (sometimes called PNES — these are episodes that look like epileptic seizures but are not caused by abnormal electrical activity in the brain). The main thing the researchers were tracking was how many of these seizure-like events each person had per week, based on diary logs kept by participants. The reported data shows that the average number of weekly seizure-like events was recorded at two points during the study. The first recorded average was 6.9 events per week, and the second recorded average was 5.3 events per week. The data as submitted does not include labels clearly identifying which measurement was taken at which time point (for example, before or after any intervention), so it is not possible to say with certainty what each number represents in the timeline of the trial. It is also worth noting that with only 10 participants, this was a very small study, and the reported results cover only this one outcome measure — no secondary outcome data was reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT03533374 · results posted 22 July 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people in total — 54 who had been diagnosed with epileptic seizures and 46 who had non-epileptic seizures. All 100 participants completed the study. The trial was looking at how well a particular type of brain-wave recording test (using something called High-Density EEG) could distinguish between epileptic and non-epileptic seizures. Specifically, it examined two approaches: one that assessed brain signals in their "raw" recorded form (called sensor space), and one that used additional processing to estimate where in the brain the signals were coming from (called source space). The reported data shows the following numbers for the two main approaches. For the standard recorded signal approach, the test correctly identified epileptic seizures in 96.3% of the epilepsy group (this is called sensitivity — how often the test correctly flags a true case), and correctly identified non-epileptic seizures in 84.8% of the non-epilepsy group (called specificity — how often the test correctly gives the all-clear). For the source-space approach, the reported sensitivity was 85.2% in the epilepsy group, and the specificity was 95.7% in the non-epilepsy group. The trial also measured how consistently different reviewers agreed with each other when reading the results; the reported agreement scores were 0.61 for the epilepsy group and 0.59 for the non-epilepsy group, which the researchers' scale described as falling in the "substantial" range. 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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NCT03116828 · results posted 16 June 2020

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called eslicarbazepine acetate (ESL), used as an add-on treatment alongside other medicines in adults diagnosed with epilepsy who experience partial-onset seizures (seizures that start in one part of the brain). A total of 102 people took part — 44 in Arm 1 and 58 in Arm 2. The two groups represented different sets of participants who had not previously taken ESL. The main thing the trial set out to measure was how many people in each group were still taking the add-on treatment after 24 weeks. The reported data shows that of the 44 people who started in Arm 1, 36 completed the full 24-week period, while 8 did not finish. In Arm 2, 37 out of the 58 who started completed the 24 weeks, with 21 not completing the study. The trial's primary outcome was simply counting the number of participants who reached that 24-week mark in each group — no additional outcome measures beyond this were included 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.

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NCT02408523 · results posted 16 April 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT02408523) enrolled 121 people in the lacosamide group and 121 people in a placebo (dummy treatment) group — 242 participants in total. The trial ran for 24 weeks and was primarily measuring how long it took for participants to experience a second major seizure (called a primary generalised tonic-clonic seizure, which is the type where the whole body convulses). Secondary measures included how long it took to have a first such seizure, how many participants had no seizures at all during the 24 weeks, and how many people in each group experienced any unwanted medical events during the trial. The reported data shows that, when looking at the primary measure — how quickly participants reached a second major seizure — 49 people in the lacosamide group and 76 people in the placebo group had that second seizure during the 24-week period. For the secondary measure of seizure freedom (having no major seizures at all during the 24 weeks), the reported data shows approximately 31.0% of participants in the lacosamide group and 17.3% in the placebo group were recorded as seizure-free. Regarding time to the first major seizure, 79 events were recorded in the lacosamide group compared with 97 in the placebo group. On the question of unwanted medical events, the reported data shows 82.6% of participants in the lacosamide group and 81.8% in the placebo group reported at least one such event — though the trial data does not tell us what those events were or how serious they were from these figures alone. The reported data also includes blood level measurements for lacosamide in those who took it, with average concentrations ranging from approximately 8.07 to 8.61 micrograms per millilitre (a measure of how much of the medicine was in the bloodstream). No blood level data was reported for the placebo group, as would be expected. 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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NCT03513757 · results posted 21 February 2020

According to the results reported on ClinicalTrials.gov, this trial (NCT03513757) enrolled 40 people in total — 22 in a group receiving propofol alone (a sedation medicine) and 18 in a group receiving a combination of propofol and dexmedetomidine (a second sedation medicine). All 40 participants completed the study with no drop-outs. The trial was measuring how long it took from the start of sedation until a person was considered ready to go home or back to a clinic, as well as tracking the doses of medicines each group received. The reported data shows that, on average, the propofol-only group took 98 minutes to reach readiness for discharge, while the propofol-plus-dexmedetomidine group took 77 minutes. In terms of medicine doses, the propofol-only group received an average of 10.6 mg per kilogram of body weight of propofol, compared with 3.0 mg per kilogram in the combination group. The combination group also received an average of 0.70 micrograms per kilogram of dexmedetomidine and 4.2 micrograms per kilogram of glycopyrrolate (another medicine used alongside sedation). Both groups received the same average dose of lidocaine (1.0 mg per kilogram). Nitrous oxide (sometimes called laughing gas) was used by 18 out of 22 participants in the propofol-only group and 17 out of 18 in the combination 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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NCT01463306 · results posted 21 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 605 children and young people across three groups: 384 who had previously taken and continued taking pregabalin, 210 who started on a placebo before switching to pregabalin, and 11 who went directly onto pregabalin. The trial was a long-term study monitoring participants for up to around 13 months. Rather than testing whether the medicine reduced seizures, the trial was primarily measuring a range of safety-related outcomes — such as unwanted medical events, changes in physical and neurological examinations, blood pressure readings, body weight changes, and physical development (using a standard staging system called Tanner staging, which tracks puberty-related development). The reported data shows that, looking at unwanted medical events (called adverse events, or AEs) that appeared or worsened after starting the study drug, 252 out of 384 participants in the first group, 140 out of 210 in the second group, and 10 out of 11 in the third group experienced at least one such event. Serious adverse events — those considered significant enough to require hospitalisation or deemed otherwise serious — were reported in 53, 23, and 1 participants across the three groups respectively. Events that investigators considered related to the study drug were reported in 104, 65, and 9 participants. No treatment-related serious adverse events were reported in the first and third groups, while one was reported in the second group. Regarding body weight, the reported data shows that most participants had a weight change of 7% or more over the study period in the first two groups, while very few experienced a decrease of that size. Clinically significant changes in physical or neurological examinations and blood pressure abnormalities were reported in smaller numbers of participants across all groups, with full details available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02726074 · results posted 5 February 2020

According to the results reported on ClinicalTrials.gov, this trial enrolled 106 people who were all given the same treatment — a medication called perampanel at a dose of 12 mg. There was no comparison or placebo group. Of the 106 people who started, 102 actually received the treatment and 80 completed the study. The trial was measuring how often participants experienced a type of epileptic seizure called a "partial onset seizure" (a seizure that starts in one part of the brain), and whether the number of those seizures changed over the course of the study. The reported data shows that, looking at the main outcome, 80% of participants had their partial onset seizure frequency cut by at least half compared to where it was at the start of the study. For the additional outcomes, the reported data shows that about 71.8% of participants had their seizure frequency reduced by at least 75%, and around 47.1% had no partial onset seizures at all during the maintenance period (the later, stable phase of the trial). In terms of overall change in seizure frequency, the reported figures show an average reduction of approximately 90.5% during the titration period (when the dose was being gradually increased) and approximately 95% during the maintenance period. For a subgroup of participants who also experienced a specific type of seizure involving full-body stiffening and jerking (called secondary generalised tonic-clonic seizures), 87.5% had their frequency of those seizures reduced by at least 50%, and the same proportion had a reduction of at least 75%. It is important to note that because this trial had only one group and no comparison group, the numbers describe what was observed in these participants without a direct comparison to another treatment or no 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.

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NCT00986310 · results posted 27 November 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT00986310) compared fluoxetine (an antidepressant medication that can also affect breathing) against a placebo (a dummy treatment) in people with epilepsy. The trial was looking at two things: first, whether fluoxetine could reduce the number of seizures during which a person's blood oxygen level dropped below 90%; and second, whether it could improve how low that oxygen level fell during those seizures. Unfortunately, the reported data shows that participant numbers were recorded as zero for both the fluoxetine group and the placebo group across all milestones — meaning no participant figures were actually submitted to the registry. The reported data shows that no numerical results were provided for either the primary or secondary outcome measures. In other words, there are no figures available showing whether seizure-related oxygen drops changed with fluoxetine compared to placebo, and no figures showing whether the lowest oxygen level recorded during those seizures was different between the two groups. Because these measurements were not reported in the data submitted, it is not possible to describe what the trial found. 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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NCT02757547 · results posted 20 August 2019

According to the results reported on ClinicalTrials.gov, this trial looked at whether Transcranial Magnetic Stimulation (TMS) — a technique that uses magnetic pulses directed at the brain — could reduce how often seizures occurred in participants. The trial used a crossover design, meaning participants first received a placebo (inactive) version of the treatment and then later received the active treatment. Only 2 people took part in the trial, and both of them completed it. The reported data shows that the primary outcome being measured was the change in seizure frequency compared to each participant's starting (baseline) level. However, no numerical results were reported for this outcome measure in the data submitted to ClinicalTrials.gov. In other words, while the trial did take place and both participants finished, no figures showing the actual seizure frequency results were included in the submitted results. Because the outcome measurement data was not reported, it is not possible to describe what the numbers showed for this trial. It is also worth noting that with only 2 participants, this was an extremely small 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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NCT02276053 · results posted 19 August 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT02276053) enrolled 93 people who were already taking lacosamide, a medication used for a type of epilepsy called partial onset seizures. There was only one group in the study — everyone received lacosamide — and participants were observed over six months. The trial was measuring things like how often seizures occurred, how patients rated their own overall health, how many people stayed on the medication for the full six months, and how quality of life changed over time. Of the 93 people who started, 79 completed the study and 14 did not. The reported data shows that, among the group used for the main analysis, 76.7% of participants had their partial onset seizure count drop by at least half compared to where they started — this group is referred to as "responders" in the trial. When participants were asked to rate how their general health felt compared to before the study (using a seven-point scale where lower scores mean improvement and higher scores mean worsening), the reported data shows 49 participants said they felt improved overall, 17 reported no change, and 10 reported feeling worse. For how many people stayed on lacosamide for the full six months, the reported figure was 63.4%. The data for the average time until people stopped taking the medication was listed as not available in the submitted results. The reported data also shows two quality-of-life measures were tracked using a standard questionnaire (EQ-5D-5L). On a 0–100 self-rated health scale, the average score changed by +1.3 points from the start to six months (where a positive number indicates a small worsening on that particular scale). A second quality-of-life measure — which converts answers about daily functioning into a score from 0 to 1 — showed an average change of −0.01, meaning a very small shift in the direction of worsening on that 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.

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NCT01529034 · results posted 25 June 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01529034) enrolled 175 people who were being treated with a nasal spray medicine called USL261, which is a form of midazolam used for clusters of seizures. Of those, 161 were actually given the treatment. The trial had only one group — there was no comparison or placebo group. The main purpose of the trial was to collect long-term monitoring (safety observation) data over time, tracking things like blood pressure, pulse, breathing, blood test results, and physical and neurological check-ups after participants used the medicine. The reported data shows that participants were followed for an average of about 16.8 months. When it came to vital signs (measurements like blood pressure and heart rate), the reported numbers show that small numbers of participants — ranging from 0 to 4 people across the various individual measurements — recorded readings that fell outside pre-set thresholds at some point, with 29 participants flagged under one broader vital signs category. For blood and urine test results, the reported data shows that 26 participants had a certain liver-related marker (a chemical the liver makes) above a set level, 17 had another liver marker elevated, and smaller numbers — mostly between 1 and 6 people — appeared in other laboratory categories. For physical examinations, only 2 participants had findings considered clinically notable by the study doctors, and for nasal examinations (checking the nose where the spray is applied), 1 participant had a notable finding. For neurological (brain and nerve) check-ups, 10 participants had findings considered clinically notable at some point. It is worth noting that of the 175 people who started the trial, only 1 completed it, with 174 recorded as not completing — though the reasons for not completing were not detailed in the data 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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NCT01390220 · results posted 31 May 2019

According to the results reported on ClinicalTrials.gov, this trial (NCT01390220) involved a treatment called USL261, a midazolam nasal spray, being studied in people experiencing prolonged or repeated seizures. The trial ran in two phases. In the first phase (the "test dose phase"), 292 participants received USL261 to check how they responded; 201 of them completed this phase. Those who responded well — 201 people — then moved into the second phase (the "comparative phase"), where 134 participants were randomly assigned to receive USL261 and 67 were assigned to receive a placebo (an inactive treatment with no medicine in it). The main thing being measured was whether participants met the criteria for "treatment success," defined as their seizure stopping within 10 minutes of receiving the study drug and not returning for at least 6 hours afterwards. The reported data shows that in the comparative phase, 72 out of 134 participants in the USL261 group met the criteria for treatment success, compared with 23 out of 67 participants in the placebo group. For the secondary outcomes — which looked at what happened after the 10-minute mark — the reported data shows that 51 out of 134 participants in the USL261 group had a seizure return between 10 minutes and 4 hours after the dose, compared with 40 out of 67 in the placebo group. When looking at seizure return over a longer 24-hour window, 50 participants in the USL261 group and 31 in the placebo group had another seizure during that period. For the time until the next seizure after 10 minutes, the reported data shows a figure of 12.1 hours for the placebo group; no corresponding figure was reported for the USL261 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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NCT01161524 · results posted 15 May 2019

According to the results reported on ClinicalTrials.gov, this trial looked at how a medication called perampanel affected cognitive function (thinking and memory abilities) compared with a placebo (a dummy treatment with no active ingredient) in people with epilepsy. In the core part of the study, which ran for 23 weeks, 85 people were assigned to receive perampanel and 48 received placebo. Most participants completed that phase — 76 in the perampanel group and 43 in the placebo group. After the core study, 114 participants entered an optional extension phase of roughly 83 weeks where everyone received perampanel; 90 of those 114 completed it. The reported data shows that the main thing being measured was a change in an overall "Global Cognition Score" — a combined score across five thinking and memory tasks — between the start of the study and week 19. Scores on this scale could range from 0 to 100, and a higher score meant better cognitive function. The perampanel group's score changed by −1.0 points (a slight decrease from their starting score), while the placebo group's score changed by +1.1 points (a slight increase). For the five individual thinking tasks that made up that overall score, the reported changes at week 19 were as follows: in "Power of Attention" (focused attention and processing speed), perampanel −6.9 versus placebo −2.7; in "Continuity of Attention" (sustained attention), perampanel −1.7 versus placebo +1.6; in "Quality of Episodic Memory" (ability to remember everyday information), perampanel +3.0 versus placebo −1.2; in "Quality of Working Memory" (holding information in mind briefly), perampanel +1.1 versus placebo +2.0; and in "Speed of Memory" (how quickly information is retrieved), perampanel +0.3 versus placebo +7.0. In all of these individual measures, a higher number represents better performance on that task. 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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NCT02598076 · results posted 24 April 2019

According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 31 in a control group and 29 in a group that received something called Motivational Interviewing (a structured style of conversation used to encourage engagement with treatment). The trial was looking at whether Motivational Interviewing could help people stick with a course of weekly talk therapy sessions for a condition called psychogenic non-epileptic seizures (PNES — episodes that look like epileptic seizures but have a psychological rather than neurological cause). By the end of the study, 29 people in the control group and 26 in the Motivational Interviewing group had completed the trial. The reported data shows that for the main thing being measured — whether participants attended at least 8 of the 12 recommended therapy sessions — 9 out of 31 people in the control group reached that level of attendance, compared with 17 out of 29 in the Motivational Interviewing group. For the secondary measures, the reported data shows the control group had a 34.8% decrease in how often seizure-like episodes occurred each month, while the Motivational Interviewing group had a 76.2% decrease. Regarding emergency department visits per month, the control group's visits changed by +0.06 (a very small increase), while the Motivational Interviewing group's changed by −0.15 (a very small decrease). Three people in the control group and 8 in the Motivational Interviewing group were reported as having had no seizure-like episodes in the three months before the study ended. The reported data also shows a change in a quality-of-life score measured using a questionnaire called the QOLIE-10, where a higher score indicates improvement. The control group's score changed by 1.8 points and the Motivational Interviewing group's score changed by 7.2 points, both measured from the start of the trial to the four-month follow-up point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01910129 · results posted 23 April 2019

According to the results reported on ClinicalTrials.gov, this trial looked at a device called gammaCore — a non-invasive nerve stimulator — in people living with epilepsy. Thirteen participants entered an initial run-in period, and 13 were then randomly assigned to one of two groups: one group used the real gammaCore device first and then switched to a sham (inactive) version, while the other group used the sham first and then the real device. Each phase lasted 8 weeks. By the end of the trial, 9 of the 13 randomised participants had completed both phases. The trial was measuring things like how often seizures occurred, how long they lasted, how severe they were, how many seizure-free days participants had, and their quality of life. The reported data shows that for seizure frequency, the group that used the real gammaCore first recorded an average of 9.1 seizures during that phase and 9.4 during the sham phase; the group that used the sham first recorded 8.2 seizures during the sham phase and 6.6 during the real device phase. For seizure duration, figures ranged between roughly 4.5 and 6.5 minutes across the different groups and phases. Seizure severity was scored on a 1–7 scale (where lower means less severe), with scores ranging from 2.8 to 4.8 across groups and phases. Quality of life was scored out of 100 (higher is better), with composite scores around 55–63 across groups and phases, and a general health sub-score of 6–7 out of 10. The reported data also shows that adverse events (unwanted experiences) occurred across both the real device and sham phases, though the detailed breakdown of what those events were is listed separately in the trial's adverse event tables rather than in the summary figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00150800 · results posted 5 December 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 667 people who were already taking a medication called brivaracetam (an anti-seizure medicine) in earlier related studies, and who continued into this long-term follow-on study. Of those 667 participants, 171 completed the study and 496 did not finish — the reasons for not completing were not broken down further in the reported data. The trial was primarily measuring how often participants experienced unwanted medical events (called adverse events) while taking the study treatment, regardless of whether those events were thought to be related to the medicine. The reported data shows that 91.2% of participants experienced at least one treatment-emergent adverse event (that is, any unwanted medical occurrence that happened during the time they were taking the study treatment). Around 22.8% of participants experienced what was classified as a serious adverse event — meaning a more significant medical occurrence — and 14.8% of participants stopped taking the study treatment because of an adverse event. For a smaller group of participants who had a specific seizure type (called partial onset seizures), the reported data shows their average seizure rate was 9.2 seizures per 28 days at the start of the previous study, compared with 4.2 seizures per 28 days during this study's evaluation period. This represented a reported average reduction of 57.3% from that earlier starting point. The reported data also shows that 55.6% of participants in that seizure subgroup had their seizure frequency reduce by 50% or more compared to their earlier baseline. 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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NCT01999777 · results posted 27 November 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT01999777) enrolled 62 people in total — 31 in each group. One group received a treatment called USL261, while the other received a placebo (a dummy treatment with no active ingredient). The trial was looking at seizure activity over a 6-hour period, specifically measuring how many participants went through that entire period without having a seizure, and how long it took before a seizure occurred after receiving the study treatment. The reported data shows that, out of the 31 people who received USL261, 17 completed the 6-hour period without a recorded seizure. In the placebo group, 12 out of 31 people did the same. For the second measure — the time until the next seizure occurred — the reported data shows a figure of 3.9 hours for the placebo group. No figure was reported for the USL261 group for this measure, so it 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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NCT01713946 · results posted 7 November 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 366 people in total — 117 in a low-dose everolimus group (aiming for a blood level of 3–7 ng/mL), 130 in a high-dose everolimus group (aiming for 9–15 ng/mL), and 119 in a placebo group (a dummy treatment with no active ingredient). The trial was measuring changes in the frequency of partial-onset seizures in people with a condition called tuberous sclerosis complex (TSC). Two main things were tracked: the proportion of participants whose seizures dropped by at least half, and the overall percentage change in how often seizures occurred. The reported data shows that, during the core phase of the trial, 28.2% of people in the low-dose everolimus group and 40.0% in the high-dose group had their seizure frequency cut by at least half, compared with 15.1% in the placebo group. When looking at the median percentage reduction in seizure frequency overall, the reported figures were approximately 29% for the low-dose group, 40% for the high-dose group, and 15% for the placebo group. For secondary measures, the reported data shows that complete seizure freedom during the core phase was recorded in 5.1% of the low-dose group, 3.8% of the high-dose group, and 0.8% of the placebo group. At least a 25% reduction in seizures was reported for 52.1%, 70.0%, and 37.8% of participants respectively. The number of additional seizure-free days per 28-day period (compared to before the trial) was reported as 2.00 days for the low-dose group, 4.01 days for the high-dose group, and 0.47 days for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00612235 · results posted 26 October 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 20 women taking lamotrigine for epilepsy, 20 taking levetiracetam, 20 taking carbamazepine, and 20 women without epilepsy who acted as a comparison group. All 80 participants completed the study. The trial was measuring how often women in each group met the recognised criteria for Premenstrual Dysphoric Disorder (PMDD) — a condition involving significant mood and physical symptoms in the days before a period. To count as meeting those criteria, a participant had to show the pattern across two menstrual cycles in a row, tracked using a daily symptom diary called the DRSP. The reported data shows that, using the stricter version of the PMDD criteria, no participants in any group — neither the epilepsy groups nor the comparison group — met the threshold. Using a less stringent version of the criteria, the reported data shows 6 out of 60 women with epilepsy met the threshold, compared with 2 out of 20 women in the comparison group. When the epilepsy groups were looked at separately, 2 out of 20 participants were recorded as meeting this looser threshold in each of the three medication groups (carbamazepine, levetiracetam, and lamotrigine). The remaining participants in each group — 18 out of 20 in every group — did not meet even this less stringent threshold. The reported data does not include a breakdown of results for the normal control group across the individual medication comparisons, only in the combined analysis. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov, so that information is 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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NCT02072824 · results posted 9 October 2018

According to the results reported on ClinicalTrials.gov, this trial looked at the medicine pregabalin in children with a type of epilepsy called partial onset seizures. A total of 175 children took part — 71 were given a lower dose of pregabalin, 34 were given a higher dose, and 70 received a placebo (a dummy treatment with no active medicine). The trial measured how often seizures occurred during a 48–72 hour period of brain-wave monitoring (called a video-EEG), comparing the pregabalin groups to the placebo group. The reported data shows that the main outcome — the seizure rate recorded during the monitoring period — was expressed using a mathematical adjustment (log transformation, a way of rescaling numbers to make them easier to compare). The reported figures were 1.69 for the lower-dose pregabalin group, 1.15 for the higher-dose group, and 1.58 for the placebo group. For a secondary measure, the trial looked at what share of participants had their seizure rate cut by at least half compared to their starting point: the reported figures were approximately 30.5% in the lower-dose group, 53.6% in the higher-dose group, and 41.5% in the placebo group. The trial also recorded unwanted medical events (called adverse events) that occurred during the study period; 32 participants in the lower-dose group, 17 in the higher-dose group, and 38 in the placebo group experienced at least one such event. Serious adverse events were reported in 0, 1, and 4 participants respectively. Any further detail on what those events involved was not broken down in the data 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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NCT02565108 · results posted 23 August 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 20 participants in total — 16 received a cannabidiol-based medicine called GWP42003-P at a dose of 20 mg/kg per day, and 4 received a placebo (an inactive dummy treatment). All participants were also already taking an anti-seizure medicine called clobazam (CLB). The trial was primarily measuring how GWP42003-P affected the way the body processed clobazam and its breakdown product (called N-CLB) — specifically looking at things like how high the levels of these substances rose in the blood, how quickly they peaked, and how much was present over time. This type of measurement is used to look for potential interactions between two medicines taken together. The reported data shows that for clobazam (CLB) itself, the peak blood levels and overall exposure on Day 33 (after 21 days of taking GWP42003-P alongside CLB) were broadly similar to Day 1 levels in the GWP42003-P group — with ratios close to 1.0 for both measures, suggesting little change. However, for N-CLB (the breakdown product of clobazam), the reported data shows notably higher ratios in the GWP42003-P group: a ratio of 2.22 for peak blood level and 2.64 for overall exposure over the dosing period. The placebo group showed ratios close to 1.0 for both clobazam and N-CLB, indicating little change over the same period. The trial's pre-set "no meaningful effect" range was 0.5 to 2.0, meaning the N-CLB figures in the GWP42003-P group fell outside that range. The reported data also notes that 1 participant in the GWP42003-P group experienced a severe treatment-related adverse event (an unwanted health event during the study), compared with 0 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.

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NCT00175825 · results posted 22 August 2018

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called brivaracetam in people with epilepsy who experience a type of seizure called partial onset seizures. A total of 208 people took part, split into four groups: 54 received a placebo (a dummy treatment with no active ingredient), 50 received 5 mg of brivaracetam per day, 52 received 20 mg per day, and 52 received 50 mg per day. The trial ran for seven weeks and tracked how often participants had seizures compared to a baseline period before treatment began. The reported data shows changes in weekly seizure frequency across the groups. For partial onset seizures specifically, the placebo group's seizure count fell by about 21.7% from their starting point, while the three brivaracetam groups saw reductions of approximately 29.9% (5 mg), 42.6% (20 mg), and 53.0% (50 mg). The reported data also shows what proportion of participants in each group had their partial onset seizures reduce by at least half during the treatment period — this was 16.7% in the placebo group, 32.0% in the 5 mg group, 44.2% in the 20 mg group, and 55.8% in the 50 mg group. When all seizure types were counted together, the percentage reductions from baseline were similarly reported as roughly 24.4% (placebo), 29.9% (5 mg), 41.6% (20 mg), and 53.1% (50 mg). It is worth noting that the data submitted includes only these secondary outcome measures — no primary outcome measure results were listed in the structured data provided to ClinicalTrials.gov, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02427607 · results posted 2 July 2018

According to the results reported on ClinicalTrials.gov, this trial (NCT02427607) enrolled 7 participants, all of whom received a medicine called perampanel. Six out of the seven participants completed the study, while one did not finish. The trial was measuring the safety and tolerability of perampanel — in other words, it was looking at any unwanted health events (called adverse events) that occurred while participants were taking the medicine, including serious ones, changes in blood test results, and changes in vital signs and weight. The reported data shows that, of the outcomes measured, 6 participants experienced what are called "treatment-emergent adverse events" (TEAEs) — meaning any health events that appeared or worsened after starting the study medicine. However, the reported data shows that 0 participants experienced treatment-related TEAEs (events the investigators considered possibly or probably linked to the medicine), 0 participants experienced serious adverse events, and 0 participants had markedly abnormal laboratory results. It is worth noting that this was a very small study with only 7 people, and the data as submitted does not include information on what specific events the 6 participants experienced. The reported data does not include any other outcome measures beyond these safety-related counts, so no further figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00310388 · results posted 6 June 2018

According to the results reported on ClinicalTrials.gov, this was a long-term open-label extension study of a medicine called retigabine, which was being investigated for epilepsy. A total of 376 participants took part in the main reporting phase, with a further 26 continuing into a separate safety follow-up phase. Because it was an open-label study, all participants knew they were receiving retigabine — there was no placebo comparison group. The study's primary focus was on tracking unwanted medical events (called adverse events) and monitoring physical measurements such as blood pressure, heart rate, and body temperature over time. The reported data shows that out of 376 participants, 324 experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that happened after starting the study drug), and 78 experienced a serious adverse event (a more severe event such as one requiring hospitalisation or that was life-threatening). Additionally, 115 participants stopped taking the study drug because of an adverse event. The reported data also shows that the probability of stopping the study drug gradually increased over time, reaching a reported figure of around 4.3% at the latest measured point — though the exact time periods for each figure were not fully detailed in the data provided here. The reported data shows that changes in blood pressure (both lying down and standing), heart rate, and body temperature were also tracked throughout the study. The recorded average changes from each participant's starting measurement were very small across all time points — for example, blood pressure changes were generally within a couple of millimetres of mercury, heart rate changes were within a few beats per minute, and body temperature changes were less than a tenth of a degree Celsius. No further breakdown of these physical measurements by individual time points was provided in a way that can be meaningfully summarised 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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NCT00761774 · results posted 23 April 2018

According to the results reported on ClinicalTrials.gov, 108 people took part in this trial, which looked at a single treatment — brivaracetam — over a period of up to nine years. The trial was measuring how many participants experienced medical events (called adverse events) while taking the treatment, including serious ones and those that caused people to stop the treatment. A secondary focus was tracking how many participants stayed on brivaracetam as their only epilepsy medicine (monotherapy) for extended stretches of time. By the end of the study, 29 participants had completed it, while 79 did not complete it. The reported data shows that 90.7% of participants experienced at least one "treatment-emergent adverse event" — meaning any unwanted medical occurrence that happened while they were taking the study medicine, whether or not it was thought to be connected to it. Around 24.1% of participants experienced what was classified as a "serious adverse event," which covers events such as hospitalisation, life-threatening situations, or lasting disability. The reported data also shows that 15.7% of participants stopped taking the treatment due to an adverse event. Regarding the secondary measurements, the reported data shows that 38.89% of participants were on brivaracetam as their only epilepsy medicine for at least 3 months, 32.41% for at least 6 months, and 25% for at least 12 months continuously during the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01921205 · results posted 19 March 2018

According to the results reported on ClinicalTrials.gov, this trial enrolled 343 adults — 172 in the placebo group and 171 in the lacosamide group — and was measuring changes in how often participants experienced a particular type of seizure called a "partial onset seizure." Of those who started, 151 people in each group completed the trial. The trial tracked seizure frequency over a set period and compared those receiving lacosamide (an anti-seizure medicine) against those receiving a placebo (an inactive dummy treatment). The reported data shows that, for the primary measure, the placebo group had an average reduction of 1.55 seizures per 28 days from their starting level, while the lacosamide group had an average reduction of 3.05 seizures per 28 days. For a key secondary measure, 33.3% of people in the placebo group and 52.9% in the lacosamide group had their seizure frequency cut by half or more during the maintenance period (the main treatment phase). When looking at larger reductions specifically, the reported data shows that 15.9% of the placebo group and 31.2% of the lacosamide group had their seizure frequency reduced by more than 75%. Across the full treatment period (including the dose-adjustment phase), 32.0% of placebo participants and 20.6% of lacosamide participants showed little to no change in seizure frequency (defined as less than a 25% change in either direction). 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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NCT02023866 · results posted 13 November 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 36 children and young people with mitochondrial disease, all of whom received a delayed-release form of a medicine called cysteamine bitartrate. Of the 36 who started, 30 completed the trial and 6 did not finish. The trial was primarily measuring changes in a scoring tool called the Newcastle Paediatric Mitochondrial Disease Scale (NPMDS), which looks at four areas of mitochondrial disease — everyday functioning, how different body systems are affected, a clinical assessment, and quality of life — with higher scores generally meaning more severe disease or lower quality of life. The reported data shows that, on the primary measure, the average change from the starting score across the four sections of the NPMDS was very small: section one changed by −0.3 points, section two by +0.1 points, section three by −0.6 points, and section four by 0.0 points (no change). The trial also measured several other things. Blood levels of a substance called glutathione (which plays a role in protecting cells) were reported to change across different time points, with figures ranging from around +10 to +141.5 units (µmol/L). Lactic acid levels in the blood showed small reported changes of between 0.0 and 0.4 units (mmol/L). For physical ability, the reported data shows mixed results in a six-minute walking test, with changes ranging from −36.2 metres to +21.3 metres depending on the time point measured. Hand grip strength, measured with a standard grip device, showed small reported changes of between 0.0 and 1.6 kilograms across different time points and hands. 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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NCT01891890 · results posted 19 September 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 72 children across three groups: 24 received lamotrigine, 27 received oxcarbazepine, and 21 received levetiracetam. Not all children completed the study — 17, 24, and 14 finished in each group respectively. The trial was measuring how these three medicines (used to treat epilepsy) related to children's thinking and behaviour, looking at things like sustained attention, memory, processing speed, fine motor skills, and emotional and behavioural difficulties. The reported data shows that for the main outcome — a computer-based attention test called the CPT-II, which produces a score from 0 to 100 (where scores above 60 suggest attention difficulties) — all three groups scored in the "inconclusive" range (roughly 40–60) at both time points measured. Lamotrigine scored around 58 at both points; oxcarbazepine went from about 57 down to 54; and levetiracetam went from about 57 down to 54. For the behaviour checklist (a parent-reported measure where scores of 67 or above are considered in the concerning range), all three groups recorded scores well below that threshold, in the mid-to-upper 30s across the study period. For the additional measures — processing speed, story memory, symbol matching, and a peg-insertion motor test — the reported numbers were also within or close to the average ranges described for those tests, though the exact interpretation of changes over time was not elaborated 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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NCT00179517 · results posted 8 August 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 40 men in total — 20 in each group. All participants received testosterone injections (Depotestosterone), but one group also took a medicine called anastrozole (T-A group) while the other took a dummy pill, or placebo (T-P group). The trial was measuring changes in sexual function scores over three months, using two questionnaires — one called the S-Score (rated out of 20) and one called the Reynolds Questionnaire (which covered sexual interest, activity, satisfaction, and function separately). By the end of the study, 18 men in the T-A group and 19 in the T-P group had completed the trial. The reported data shows the following average changes in questionnaire scores over the three months. For the S-Score (out of 20, higher is better), the T-A group showed an average increase of 3.7 points, compared to 2.5 points in the T-P group. On the Reynolds Questionnaire, the T-A group showed average increases of 2.4 (sexual interest), 11.1 (sexual activity), and 2.4 (sexual satisfaction), while the T-P group showed average increases of 1.5, 4.7, and 2.1 respectively. For sexual function (where lower scores are considered better on this particular scale), the T-A group showed a change of −1.7 and the T-P group −1.3. Regarding the secondary outcome of reaching a "normalised" S-Score (a score of 16 or more out of 20), the reported data shows 13 out of 18 men in the T-A group reached this level, compared to 9 out of 19 men in the T-P group. The reported data also shows changes in hormone levels measured in the blood. The average change in bioavailable testosterone (the form of testosterone most readily used by the body) was reported as +150.9 ng/dL in the T-A group and +161.7 ng/dL in the T-P group. For estradiol (a hormone related to testosterone), the T-A group showed an average change of −14.6 pg/mL, while the T-P group showed +8.6 pg/mL. The ratio of bioavailable testosterone to estradiol was reported as 145.47 in the T-A group and 12.78 in the T-P group, and the ratio of bioavailable testosterone to luteinising hormone (a hormone involved in regulating testosterone production) was 450.24 in the T-A group and 482.65 in the T-P 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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NCT01465997 · results posted 2 August 2017

According to the results reported on ClinicalTrials.gov, this trial compared two medicines — lacosamide and carbamazepine-controlled release (CBZ-CR) — over a period of up to three and a half years. A total of 279 people were assigned to the lacosamide group and 269 to the CBZ-CR group. By the end of the study, 211 people in the lacosamide group and 180 in the CBZ-CR group had completed the trial. The reported data shows that the trial's main measurements focused on unwanted medical events (called adverse events) that occurred during treatment. In the lacosamide group, 181 out of 279 participants experienced at least one such event, compared with 182 out of 269 in the CBZ-CR group. When looking at people who left the study early because of an unwanted medical event, the reported data shows 12 people did so in the lacosamide group and 21 in the CBZ-CR group. The trial also tracked serious adverse events — defined as events that were life-threatening, required hospitalisation, resulted in lasting disability, or caused death. The reported data shows 32 participants in the lacosamide group and 22 in the CBZ-CR group experienced at least one serious adverse event during the treatment period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02539134 · results posted 12 July 2017

According to the results reported on ClinicalTrials.gov, this trial tested an investigational drug called TAK-935 in a total of 40 healthy adult participants. Ten people received a placebo (a dummy treatment with no active ingredient), while the remaining 30 were split across five groups, each receiving a different dose of TAK-935 — ranging from 100 mg once daily up to 600 mg once daily, or 300 mg twice daily. The trial was primarily measuring things like unwanted medical events that occurred during treatment, unusual changes in blood and urine test results, unusual changes in vital signs (such as blood pressure and heart rate), and unusual changes in heart tracings (ECGs). It also measured how the drug moved through the body by tracking its levels in the blood over time. The reported data shows that the percentage of participants who experienced at least one unwanted medical event during the study varied widely across groups: 0% in the 100 mg once-daily group, about 17% in the 300 mg once-daily group, 50% in the 600 mg once-daily group, and 83% each in the 300 mg twice-daily and 400 mg once-daily groups, compared with 40% in the placebo group. For unusual blood or urine test results, the reported figures were 0% across most groups, with the exception of 17% in the 300 mg twice-daily group. Unusual vital sign readings were recorded in 33% of participants across most TAK-935 groups and 70% of the placebo group. Unusual ECG readings were reported in between 33% and 67% of participants across the TAK-935 groups, and 70% of the placebo group. For the blood-level measurements, the reported data shows that the peak concentration of TAK-935 in the blood generally increased with higher doses, ranging from roughly 419–469 ng/mL at the lowest dose up to around 2,375–2,709 ng/mL at higher doses, though some figures for certain time points were not reported in the data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01673828 · results posted 28 June 2017

According to the results reported on ClinicalTrials.gov, this trial (NCT01673828) involved 13 people in total — 7 received allopregnanolone and 6 received a placebo (a dummy treatment with no active ingredient). All 13 participants completed the study with no drop-outs. The trial was measuring functional recovery after what appears to be a brain injury, using a tool called the Extended Glasgow Outcome Scale (GOS-E). This scale rates a person's overall functioning on a scale from 1 to 8, where 1 means death and 8 means the best possible recovery. The reported data shows that participants in the allopregnanolone group had an average GOS-E score of 4.2, while participants in the placebo group had an average score of 4.3. On the 8-point scale, both scores sit in the range described as "upper severe disability." No other outcome measures were reported in the structured results data submitted to ClinicalTrials.gov. It is worth noting that this was a very small trial with only 13 participants across both groups, and no further detail about what these numbers mean in terms of treatment benefit was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01833247 · results posted 5 May 2017

According to the results reported on ClinicalTrials.gov, this trial enrolled 12 adults who were inpatients at an epilepsy unit. All 12 participants completed the study — none dropped out. The trial was measuring levels of lactic acid (a substance the body produces during physical stress) in three places — saliva, a fingertip (capillary) blood sample, and a vein (intravenous) blood sample — all taken within 10 minutes after a seizure ended. The researchers were interested in whether saliva might be a practical, easy-to-access way to measure lactic acid after a seizure, since collecting saliva is simpler than drawing blood. The reported data shows the following average lactic acid readings after seizures: saliva samples recorded 8.16 mmol/L (millimoles per litre, a standard unit for measuring substances in body fluids), fingertip blood samples recorded 5.67 mmol/L, and vein blood samples recorded 8.6 mmol/L. For context, the trial noted that a typical baseline lactic acid level in the blood at rest is expected to be below 2.2 mmol/L, so all three readings were above that resting level. The trial also planned to look at how closely the saliva and blood readings matched each other, but the data for that particular comparison was not reported on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01128959 · results posted 5 December 2016

According to the results reported on ClinicalTrials.gov, this trial involved 108 people who were given an intravenous (into-the-vein) form of a medicine called carbamazepine. The trial ran in two stages: a lead-in period and a treatment period. Of the 108 who started, 105 moved into the treatment period, and 101 completed it. The trial was measuring adverse events — that is, any unwanted or unexpected experiences that participants had while receiving the medicine. The reported data shows that the primary outcome being tracked was the number of adverse events, and results were broken down by how quickly the medicine was given through the drip. For participants who received the infusion over 15 minutes, 126 adverse events were recorded in total. For those who received it over 5 minutes, 26 adverse events were recorded. The data does not provide a breakdown of what those individual events were, how serious they were, or how many participants experienced them — only the total counts were reported here. No secondary outcome measure data was included in the submitted results. It is worth noting that adverse events are recorded as part of standard trial monitoring and their presence does not on its own tell us whether a treatment is beneficial or harmful overall — that requires careful interpretation by medical professionals. 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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NCT01673282 · results posted 15 November 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01673282) involved 311 people with epilepsy who were already taking other anti-seizure medicines and had Vimpat (lacosamide) added to their treatment. Participants were split into two groups depending on the type of anti-seizure medicine they were already taking: 153 people were taking a sodium channel-blocking medicine alongside Vimpat, and 158 were taking a non-sodium channel-blocking medicine alongside Vimpat. The trial tracked what happened to the doses of those existing medicines over six months. The reported data shows that the main thing being measured was the change in what is called "drug load" — a way of calculating how much of their other anti-seizure medicines participants were taking relative to a standard reference dose. The reported data shows that, over the six-month observation period, people in the sodium channel-blocking medicine group had their drug load reduced by an average of 15.0%, while people in the non-sodium channel-blocking medicine group had their drug load reduced by an average of 4.4%. These numbers simply reflect a change in the doses of the other medicines being taken; they do not on their own indicate whether any particular outcome was better or worse for participants. It is also worth noting that not everyone completed the study — 33 people in the first group and 26 in the second group did not finish, though the reasons for this were not reported in the data 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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NCT01954121 · results posted 11 August 2016

According to the results reported on ClinicalTrials.gov, this trial compared two medications — levetiracetam and carbamazepine-IR (an immediate-release form of carbamazepine) — in people with epilepsy. A total of 220 people were assigned to the levetiracetam group and 216 to the carbamazepine-IR group at the start. The trial's main goal was to measure what proportion of participants went without a seizure during a six-month assessment period. Fewer people completed the full study than started it — 93 out of 220 in the levetiracetam group and 125 out of 216 in the carbamazepine-IR group finished. The reported data shows that, among those who followed the study protocol closely, 47.3% of participants in the levetiracetam group and 68.4% in the carbamazepine-IR group remained seizure-free during that six-month evaluation period. For one of the secondary measures — how many participants stayed in the study across the full treatment period — the reported figures were 48.4% for levetiracetam and 70.2% for carbamazepine-IR. The trial also tracked the number of participants who experienced a first seizure or stopped the study early due to a side effect or the treatment not working; 88 such events were recorded in the levetiracetam group compared with 45 in the carbamazepine-IR group. When looking only at first seizures (not dropouts), 87 events were reported for levetiracetam and 39 for carbamazepine-IR. Across the broader treatment period from the very first dose, 97 events were recorded for levetiracetam and 57 for carbamazepine-IR. 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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NCT00368251 · results posted 13 April 2016

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called brivaracetam in people with a condition involving involuntary muscle jerks (myoclonus). A total of 56 people took part — 18 received a dummy pill (placebo), 20 received a low dose of brivaracetam (5 mg per day), and 18 received a higher dose (150 mg per day). The main thing being measured was how much participants' scores on a standardised muscle-jerk test (called the Action Myoclonus Score) changed between the start and end of the treatment period. A positive percentage change in this scoring system means the score improved (got lower), while a negative change means it got worse. The reported data shows that, on the primary measure, the placebo group's scores improved by about 17%, the low-dose brivaracetam group's scores worsened by about 5%, and the higher-dose group's scores improved by about 12%. For the secondary measures, the reported data shows that scores for day-to-day functional disability were unchanged (0% change) across all three groups. On a measure of sensitivity to outside stimulation, the low-dose group showed a reported improvement of around 43%, while the placebo and higher-dose groups showed no change. On a patient-reported questionnaire about their symptoms, the placebo group's scores worsened slightly (about −10%), the low-dose group showed no change, and the higher-dose group showed a small improvement of around 5%. Investigators also rated overall change on a 7-point scale; the reported data shows roughly half of participants in each group were rated as having "no change," with the remaining participants spread across improvement and worsening 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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NCT00698581 · results posted 13 April 2016

According to the results reported on ClinicalTrials.gov, this trial involved 88 people in total — 68 received a daily dose of 50 mg of a medicine called brivaracetam, and 20 received 100 mg per day. The trial was looking at brivaracetam as a potential treatment for epilepsy, and its main focus was on measuring how many participants met certain pre-set "exit criteria" (meaning their seizures worsened or reached a defined threshold) over a period of 112 days, after their usual epilepsy medicines were gradually reduced. By the end of the study, 23 people in the 50 mg group and 8 people in the 100 mg group had completed the full study period. For the main (primary) outcome, the reported data shows that in the 50 mg group, the proportion of participants who met an exit criterion over the 112 days was estimated at 0.487 — meaning roughly 49 in every 100 participants in that group reached one of those exit points. This figure was compared against a historical benchmark (a reference rate of 0.722, or about 72 in 100, from previous research), but what this comparison means clinically is a matter for medical professionals to interpret. The reported data also shows that when it came to side effects (called adverse events), 53 of the 68 participants in the 50 mg group and 11 of the 20 in the 100 mg group experienced at least one side effect during the study. In the 50 mg group, 9 participants stopped the study because of side effects, compared to 2 in the 100 mg group. Serious adverse events were reported in 5 participants in the 50 mg group and none in the 100 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00490035 · results posted 13 April 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 399 adults across four groups: 100 received a placebo (a dummy treatment with no active ingredient), 99 received brivaracetam at 20 mg per day, 100 received 50 mg per day, and 100 received 100 mg per day. The trial ran over a 12-week treatment period and was measuring how often participants experienced a particular type of epileptic seizure — called partial onset seizures — each week. The vast majority of participants in each group completed the trial, with completion numbers ranging from 88 to 94 out of 100 per group. The reported data shows that the average number of partial onset seizures per week during the 12-week treatment period was 1.75 for the placebo group, 1.34 for the 20 mg brivaracetam group, 1.49 for the 50 mg group, and 1.26 for the 100 mg group. When looking at the percentage change from participants' seizure rates before the trial started, the placebo group showed a reported reduction of around 17%, while the three brivaracetam groups showed reductions of approximately 30%, 27%, and 32% respectively. The reported data also shows what proportion of participants had their seizure frequency cut by at least half during the treatment period: 20% in the placebo group achieved this, compared with 27.3% in both the 20 mg and 50 mg groups, and 36% in the 100 mg group. Seizure freedom across the entire 12-week period — meaning no seizures at all — was reported in 0% of the placebo group, 2% of the 20 mg group, 0% of the 50 mg group, and 4% of the 100 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00464269 · results posted 13 April 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT00464269) enrolled 400 adults across four groups to study a medicine called brivaracetam (BRV) in people who experience partial onset seizures (a type of epileptic seizure that starts in one part of the brain). Participants were randomly assigned to receive either a dummy pill (placebo) or one of three daily doses of BRV — 5 mg, 20 mg, or 50 mg — over a 12-week treatment period. The main thing being measured was how often participants had this type of seizure each week during treatment. Of those who started, 93 placebo participants, 82 in the 5 mg group, 93 in the 20 mg group, and 93 in the 50 mg group completed the study. The reported data shows that the average number of partial onset seizures per week during the 12-week treatment period was 2.15 for the placebo group, 1.80 for the 5 mg group, 1.96 for the 20 mg group, and 1.70 for the 50 mg group. Looking at percentage change from the starting point, the reported data shows reductions of around 17.75% for placebo, 19.95% for 5 mg, 22.52% for 20 mg, and 30.47% for 50 mg. For one of the secondary measures — the number of people whose seizure frequency dropped by at least half compared to their starting level — the reported figures were 16 out of 96 in the placebo group, 21 out of 96 in the 5 mg group, 23 out of 99 in the 20 mg group, and 33 out of 101 in the 50 mg group. Regarding complete freedom from all seizures over the full 12 weeks, the reported data shows this was recorded in 0% of the placebo group, 1% of the 5 mg group, 1% of the 20 mg group, and 4% of the 50 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01243177 · results posted 23 February 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 886 people in total — 444 in the lacosamide group and 442 in the carbamazepine controlled-release (CBZ-CR) group. The trial was comparing the two medicines in people with newly diagnosed epilepsy, and it was measuring how many participants went without a seizure for extended periods after settling on their final dose. The trial also tracked unwanted medical events (called adverse events) that occurred during treatment. The reported data shows that, when looking at seizure freedom over six consecutive months, an estimated 89.8% of the lacosamide group and 91.1% of the CBZ-CR group remained seizure-free (these figures come from a statistical estimation method called Kaplan-Meier, which accounts for people who left the study early). In a stricter analysis group that only included people who followed the study rules closely, those figures were 91.4% and 92.8% respectively. For a longer period of 12 consecutive months, an estimated 77.8% of the lacosamide group and 82.7% of the CBZ-CR group were reported as remaining seizure-free. Regarding unwanted medical events during treatment (up to about two years), the reported data shows that 328 people in the lacosamide group and 332 in the CBZ-CR group experienced at least one such event. Of those, 47 in the lacosamide group and 69 in the CBZ-CR group left the study because of an unwanted medical event. Serious unwanted medical events were recorded in 32 people in the lacosamide group and 43 in the CBZ-CR 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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NCT00735397 · results posted 26 January 2016

According to the results reported on ClinicalTrials.gov, this trial enrolled 1,218 participants who all received a medication called perampanel. The trial was an open-label extension study, meaning all participants knew they were taking the active drug. It was measuring two main things: any unwanted medical events (called adverse events) that occurred during treatment, and whether participants' seizure frequency changed over time compared to before they started perampanel. The reported data shows that out of 1,218 participants who started the study, only 35 completed it, while 1,183 did not complete it (the reasons for not completing were not broken down in the data provided). Regarding unwanted medical events, 1,018 participants experienced at least one non-serious adverse event, and 288 participants experienced at least one serious adverse event during the study period. For seizure frequency, the reported data shows a reduction in the number of seizures per 28 days compared to each participant's individual starting point. Across all seizure types combined, the reported median percentage reduction (that is, the middle value when all results are lined up) ranged from around 29% to 47% depending on the time period measured. For a specific seizure type called secondarily generalised seizures, the reported reductions were larger, ranging from around 55% to 81%. The reported data also shows that between roughly 31% and 46% of all participants experienced a halving or greater reduction in their seizure frequency, depending on the time point — rising to between around 55% and 68% for those with secondarily generalised seizures. 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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NCT01393743 · results posted 11 January 2016

According to the results reported on ClinicalTrials.gov, this trial (NCT01393743) looked at a medicine called perampanel in people who experience a type of epileptic seizure known as a primary generalised tonic-clonic seizure — where a person loses consciousness and has convulsions affecting the whole body. The core (main) part of the study included 82 people who received a placebo (a dummy treatment with no active ingredient) and 81 people who received perampanel. After the core study finished, 138 participants moved into an extension phase where everyone received perampanel for a longer period. Of those 138, 78 completed the extension phase and 60 did not. The reported data shows that, during the core study, the middle-point (median) percentage reduction in how often these seizures occurred per 28 days was about 38% for the placebo group and about 76% for the perampanel group, compared to how often seizures were happening before the study began. When looking at how many participants had at least a 50% drop in seizure frequency, the reported figures were about 40% of people in the placebo group and about 64% in the perampanel group. For all seizure types combined (not just the main type being studied), the reported median reductions were about 23% for placebo and about 43% for perampanel. In the longer extension phase, the proportion of perampanel-treated participants reported to have at least a 50% reduction in seizure frequency ranged from around 55% to about 91% across different time points measured during that phase. 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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NCT00368472 · results posted 10 December 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 138 people, all of whom received the study drug perampanel. The trial was looking at a type of epilepsy involving partial-onset seizures (seizures that start in one area of the brain). The study tracked two main things: any unwanted medical events that occurred while participants were taking the drug, and whether the frequency of seizures changed compared to before they started taking perampanel. The reported data shows that, of the 138 people who started the trial, 33 completed it and 105 did not finish. Regarding unwanted medical events, 112 participants were reported to have experienced at least one non-serious adverse event (an unexpected medical occurrence that was not considered life-threatening or requiring hospitalisation), and 33 participants experienced at least one serious adverse event (a more severe medical occurrence, such as one requiring hospitalisation). For seizure frequency, the reported data shows an average reduction of 31.5% in the number of seizures per 28-day period compared to before participants started taking perampanel. Additionally, 36.2% of participants were reported to have experienced a reduction in seizure frequency of 50% or more — meaning roughly one in three participants had at least half as many seizures as before. It is worth noting that this was a single-group study with no comparison group, and the relatively small number of people who completed the trial (33 out of 138) means the reported figures should be read with that context in mind. 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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NCT01463033 · results posted 2 November 2015

According to the results reported on ClinicalTrials.gov, this trial involved 126 people who had suffered an acute head injury and were considered at high risk of developing post-traumatic epilepsy (seizures that occur as a result of a brain injury). Sixty-six participants received a medication called levetiracetam for 30 days, while 60 participants were observed without receiving that medication. The trial's main goal was to measure how many people in each group went on to develop post-traumatic epilepsy. By the end of the study, 59 people in the levetiracetam group and 54 in the observation group had completed the trial. The reported data shows that, for the primary outcome, 6 out of 66 participants in the levetiracetam group developed post-traumatic epilepsy, compared with 8 out of 60 participants in the observation group. For the secondary outcome, adverse events (unwanted health occurrences noted during the study) were tracked only in the levetiracetam group over their 30-day treatment period. The reported data shows a series of event counts across different categories — 28, 28, 20, 9, 8, 15, 10, 10, 6, 7, 5, and 7 — however, the labels identifying what each of these individual counts refers to were not included in the data reported to ClinicalTrials.gov, so it is not possible to describe each figure in further detail. 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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NCT01318408 · results posted 23 June 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 24 participants in a single open-label group (meaning everyone received the same treatment and knew they were receiving it). The trial was measuring changes in cognitive (thinking and memory) function in people with Alzheimer's disease over a three-month period. Of the 24 people who started, 16 completed the trial and 8 did not finish. The reported data shows two main cognitive tests were used. The first was the MMSE (a 30-point thinking and memory test, where lower scores mean greater difficulty). At the start of the trial, participants scored an average of 18.2 out of 30, and over three months the average score changed by 2.2 points — though the data as submitted does not clearly separate whether this figure represents the final score or a change from baseline. The second test was the ADAS-cog (a 70-point scale where lower scores suggest less impairment). The reported starting average was 25.5, with a reported change of −4.3 points over three months, meaning scores moved in a lower direction on that scale. The trial also planned to measure daily living activities, behaviour, and physical movement, but the reported data shows no results were submitted for those additional measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00530855 · results posted 3 June 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled 322 people who were taking a medication called lacosamide for epilepsy. The study was measuring how many participants were able to take lacosamide as their only epilepsy medication (rather than in combination with other epilepsy drugs), and for how long they were able to do so. Of the 322 people who started, 210 completed the study and 112 did not finish. The reported data shows that 292 out of 322 participants were on lacosamide as their sole epilepsy medication at some point during the study period. The average length of time participants spent on lacosamide as their only epilepsy medication was reported as approximately 479 days (roughly 16 months), though the data does not report the full range of individual durations. The reported data also shows that two secondary outcomes were tracked relating to unwanted medical events (called "adverse events") that occurred during the study. According to the results reported on ClinicalTrials.gov, 296 out of 322 participants experienced at least one such event at some point during the study. Of those, 22 participants had an adverse event that led them to stop taking part in the trial altogether. The results do not describe what those events were or how serious they were. 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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NCT01772654 · results posted 6 March 2015

According to the results reported on ClinicalTrials.gov, this trial involved 17 people in total — 2 people who had been diagnosed with left temporal lobe epilepsy, and 15 people without epilepsy who acted as a comparison group (sometimes called "controls"). All 17 people completed the study with no drop-outs. The trial was looking at whether a particular type of brain scan — called Arterial Spin Labelling (ASL) — could detect differences in blood flow in a specific region of the brain between the two groups. The ASL scan was added as an extra 4-minute step during an MRI that epilepsy patients were already having as part of their usual care. It did not use any dye, contrast agent, or radiation. The reported data shows that the primary thing being measured was the intensity of the MRI signal in a part of the brain called the left temporal precentral zone. Signal intensity was expressed as a ratio — essentially comparing the brightness of that brain region on the scan against a reference area considered to be stable. According to the results reported on ClinicalTrials.gov, the average ratio for the epilepsy group was 1.06, while the average ratio for the control (no epilepsy) group was 1.04. No other outcome measures were reported in the submitted data. It is worth noting that with only 2 participants in the epilepsy group, the data as reported is very limited in scope. 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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NCT01191086 · results posted 23 February 2015

According to the results reported on ClinicalTrials.gov, this trial (NCT01191086) involved 210 people who all received the study treatment, USL255 (an extended-release form of topiramate, a medicine used for epilepsy). The trial was set up as an "open-label" study, meaning all participants knew they were receiving USL255 — there was no comparison group or placebo. Of the 210 people who started, 148 completed the study and 62 did not finish. The main thing the trial was set up to measure was the occurrence of adverse events (unwanted or unexpected health events that happened during the study) and the results of laboratory tests taken throughout. The reported data shows the following numbers of participants experiencing adverse events in various categories: 210 participants were assessed overall; 146 reported experiencing at least one adverse event; 102 experienced what were classified as treatment-related adverse events; 15 experienced serious adverse events; 14 experienced serious adverse events considered related to the treatment; 20 discontinued (stopped taking part) due to an adverse event; no participants died during the study; and 1 participant experienced a serious adverse event that led to stopping the treatment. It is important to note that the data submitted does not include a full breakdown of what specific adverse events occurred or further detail on laboratory findings. 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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NCT01678976 · results posted 8 January 2015

According to the results reported on ClinicalTrials.gov, this trial involved 13 people in total across two groups. It was a "crossover" study — meaning each participant took both medicines at different times — comparing a drug called BIA 2-093 (also known as eslicarbazepine acetate) with an older medicine called oxcarbazepine, both taken once daily at a dose of 900 mg. The trial was measuring how each drug was absorbed and processed by the body, specifically how much of the drug and its breakdown products (called metabolites) appeared in the blood and how quickly. The reported data shows the following for the primary outcome — the peak level of drug measured in the blood (the highest concentration reached). For BIA 2-093, the main breakdown product (BIA 2-194) reached a peak blood level of 15,753 ng/mL, compared to 5,978 ng/mL for oxcarbazepine's equivalent. A second breakdown product (BIA 2-195) reached 428 ng/mL with BIA 2-093 versus 1,708 ng/mL with oxcarbazepine. The remaining parent drug (oxcarbazepine itself) measured 140 ng/mL with BIA 2-093 versus 1,268 ng/mL with oxcarbazepine. The secondary outcome — a measure of the total amount of drug exposure over time — followed a similar pattern across all three substances measured. Regarding adverse events (unwanted side effects noted during the study), the reported data shows that all 6 participants who took BIA 2-093 and all 6 who took oxcarbazepine reported at least one adverse event, though the specific nature of those events was not detailed in the structured data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT02288312 · results posted 8 January 2015

According to the results reported on ClinicalTrials.gov, this trial involved 18 participants in total, divided equally into three groups of six people each. The trial was measuring how a drug called BIA 2-093 (and one of its breakdown products in the body, called BIA 2-005) behaved in the bloodstream under different conditions: one group took an 800 mg dose while fasting, another took the same dose after eating a meal, and the third group took the same total dose split into two 400 mg tablets. One participant in the fasting group did not complete the study; all participants in the other two groups completed it. The reported data shows the following measurements for the breakdown product BIA 2-005 across the three groups. The peak level of the substance detected in the blood (the highest concentration reached) was approximately 10,973 ng/mL in the fasting group, 11,044 ng/mL in the fed group, and 11,022 ng/mL in the two-tablet group. The time it took to reach that peak level was around 2.64 hours (fasting), 2.75 hours (fed), and 2.56 hours (two tablets). The total amount of the substance present in the blood over time — a measure of overall exposure — was reported as approximately 241,651 ng·h/mL (fasting), 234,092 ng·h/mL (fed), and 242,375 ng·h/mL (two tablets) up to the last measurable point, and approximately 243,808, 236,089, and 244,821 ng·h/mL respectively when estimated out to infinity. 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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NCT02171195 · results posted 7 January 2015

According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 64 participants across nine groups. Sixteen people received a placebo (a dummy treatment with no active ingredient), while the remaining 48 were spread evenly across eight groups, each receiving a different dose of the investigational treatment — ranging from 20 mg up to 1,200 mg, with 6 participants in each dose group. Every single participant who started the trial also completed it, with no drop-outs recorded in any group. The primary outcome the trial was set up to measure was the total number of "adverse events" — that is, any unwanted or undesirable experience a participant had during the study, regardless of whether it was thought to be related to the treatment. The reported data shows the following adverse event counts per group: Placebo – 7 events; 20 mg – 7 events; 50 mg – 3 events; 100 mg – 7 events; 200 mg – 2 events; 400 mg – 1 event; 600 mg – 1 event; 900 mg – 2 events; and 1,200 mg – 7 events. The data also includes a partial second set of figures (Placebo – 0, 20 mg – 2, 50 mg – 0), however no further context or labels were provided for these additional numbers in the submitted results, so what they specifically refer to cannot be determined from the available data. No secondary outcome measures were included in the results data submitted to ClinicalTrials.gov for this trial, so no further findings can 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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NCT02281448 · results posted 3 December 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT02281448) involved 20 participants in total — 10 in each of two treatment sequence groups. The trial was measuring how a drug called BIA 2-093 (taken once daily for 15 days at a dose of 1,200 mg) affected levels of that drug and its active form (called BIA 2-194) in the bloodstream. It also looked at whether taking BIA 2-093 alongside a single dose of an oral contraceptive (Microginon®) changed how much of the contraceptive's hormones were absorbed into the blood, compared to taking the contraceptive on its own. Of the 20 participants who started, 17 completed the trial (8 from one group and 9 from the other); 3 did not complete it, though the reasons were not detailed in the data provided. The reported data shows that blood levels of BIA 2-194 — the active form of BIA 2-093 — were measured on multiple days. On day 1, the peak level recorded was 0 ng/mL (nanograms per millilitre), rising across subsequent days to peaks ranging from approximately 8,443 to 10,961 ng/mL, with the final measurement on day 15 recorded at around 9,978 ng/mL. For the contraceptive (Microginon®), the reported data shows the peak hormone levels (Cmax) when taken with BIA 2-093 were 53.4 and 3,220 pg/mL (picograms per millilitre) for its two hormone components, compared with 66.1 and 3,720 pg/mL when taken alone. The time it took to reach those peak levels (Tmax) was reported as approximately 1.67 and 1.28 hours when taken with BIA 2-093, versus 1.52 and 1.21 hours alone. A measure of overall exposure to the hormones over time (AUC0-t, which reflects the total amount of a substance in the blood across a period) was reported as 347 and 24,000 pg·h/mL with BIA 2-093, compared to 595 and 33,600 pg·h/mL without it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01484977 · results posted 26 November 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01484977) involved 120 people who were given a medication called lacosamide. The trial ran for 21 weeks and had one main thing it was measuring: how many participants stayed on the treatment for the full 21-week period. This measure — called "retention" — is used in epilepsy studies as a way of capturing both how well patients and their doctors felt the treatment was going in terms of its effects and how well it was tolerated. The reported data shows that 93 out of the 120 participants who started the study completed it, while 27 did not finish. In terms of the main outcome, the reported figure for retention at the end of the 21-week treatment period was 73.3% — meaning that, according to the reported data, roughly 73 out of every 100 participants remained on the treatment through to the end of the study period. No secondary outcome measure data appears to have been included in the results submitted, so those figures cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01506882 · results posted 13 October 2014

According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called levetiracetam in people with epilepsy. The trial was split into two groups based on dose: 61 people were in the lower-dose group (1,000–2,000 mg per day) and 10 people were in the higher-dose group (3,000 mg per day). The main thing the trial was measuring was how many people in the lower-dose group had no seizures at all during a continuous 26-week (roughly six-month) period of treatment. The reported data shows that in the lower-dose group, 73.8% of participants were recorded as having no seizures during that 26-week period. When the follow-up was extended to a full 52 weeks (about one year), the reported figure dropped to 59.0% remaining seizure-free. For the higher-dose group (3,000 mg per day), the reported data shows that 22.2% were seizure-free over 26 weeks, and 11.1% over 52 weeks. Two additional measures — the time until a first seizure occurred and the time until someone left the study — were listed as outcomes in the lower-dose group, but the reported data shows these figures were not available (listed as "NA" in the submitted results). It is worth noting that of the 61 people who started in the lower-dose group, 39 completed the study, while 22 did not; in the higher-dose group, only 3 of the 10 who started went on to complete it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01292837 · results posted 12 August 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom received the medication levetiracetam. Eleven participants completed the study, while two did not finish. The trial was measuring changes in how often participants experienced a specific type of seizure — called a generalised tonic-clonic seizure (a seizure involving loss of consciousness and muscle convulsions affecting the whole body) — over a 24-week treatment period, compared to a baseline period before treatment began. The reported data shows that, on average, participants experienced a 45.47% reduction in how frequently these seizures occurred per week across the full 24-week treatment period, compared to their baseline. Looking at the later "evaluation" portion of the treatment period alone, the reported reduction was 44.93%. The reported data also shows that approximately 53.8% of participants had their seizure frequency cut by half or more during the overall treatment period, and 58.3% reached that same threshold during the evaluation period. In terms of complete absence of these seizures, 2 out of the 13 participants reported no generalised tonic-clonic seizures at all during the treatment period, and 2 participants also reported none during the evaluation period. It is worth noting this was a small, single-group trial with no comparison group, which limits how broadly its numbers can be interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01668654 · results posted 4 August 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01668654) enrolled 4 participants, all of whom received the study medicine retigabine/ezogabine (taken three times a day). The trial was a follow-on study designed to continue monitoring participants from an earlier related trial. It was measuring things like unwanted medical events (called adverse events), serious medical events, whether participants had to stop taking the medicine because of those events, and whether their vital signs — such as blood pressure, heart rate, and body temperature — showed any notable changes. Importantly, none of the 4 participants completed the study, as it was ended early before everyone finished. The reported data shows that all 4 participants experienced at least one adverse event (an unwanted medical occurrence that happened while taking the study medicine). The reported data also shows that none of the 4 participants had a serious adverse event (defined as one involving death, a life-threatening situation, hospitalisation, disability, or a birth defect), and none withdrew from the study due to an adverse event. Additionally, no participants were reported to have vital sign readings (blood pressure, heart rate, or body temperature) that fell outside the ranges considered clinically important. For the measures looking at how blood pressure, heart rate, and body temperature changed from the start of the study, the reported data shows that no summary numbers were compiled. According to the results reported on ClinicalTrials.gov, this was because the study was ended earlier than planned and the number of participants was too small to meaningfully summarise those figures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01098162 · results posted 22 July 2014

According to the results reported on ClinicalTrials.gov, this trial enrolled 573 adults who were taking a medicine called Vimpat® (lacosamide) for a type of epilepsy known as partial-onset seizures. There was only one group in the study — everyone received Vimpat®. The main thing the trial was measuring was how doctors rated each participant's overall condition after six months compared to when they started, using a standard scale called the Clinical Global Impression of Change. The trial also tracked how often seizures occurred over the study period. Of the 573 people who started, 461 completed the study and 112 did not. The reported data shows that, at the six-month mark, doctors rated participants' conditions as follows: 160 were rated "very much improved," 179 "much improved," 66 "minimally improved," 72 "no change," 16 "minimally worse," 9 "much worse," and 2 "very much worse." Eleven participants were not assessed. For seizure frequency, the reported data shows that the average number of partial-onset seizures (not spreading to the whole brain) per 28 days was reported to have changed by −3.80 at three months and −4.24 at six months compared to the starting point — meaning, on average, the count was lower. For seizures that did spread to involve the whole brain, the average change per 28 days was reported as −0.39 at both three and six months. Additionally, 277 out of 573 participants were reported to have experienced at least one adverse event (an unwanted or unexpected medical occurrence) during the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01142193 · results posted 7 May 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT01142193) enrolled 249 adults with partial-onset seizures (a type of epilepsy where seizures start in one part of the brain). Participants were randomly assigned to receive either USL255 (124 people) or a placebo — a dummy treatment with no active ingredient (125 people). The trial was measuring how much the frequency of seizures changed over the course of the study compared to each person's starting point. The reported data shows that, for the main outcome, the USL255 group had a reported average reduction of about 39.5% in weekly partial-onset seizure frequency, while the placebo group had a reported average reduction of about 21.6%. For one of the secondary outcomes — the proportion of people whose weekly seizures dropped by at least half — 37.9% of the USL255 group reached that mark, compared with 23.2% in the placebo group. During the earlier titration phase (the period where the dose was gradually increased), the reported data shows 33.9% of the USL255 group and 17.6% of the placebo group had at least a 50% reduction in weekly seizures. Looking at larger or complete reductions during the titration phase, the reported figures show that 56.5% (USL255) versus 34.4% (placebo) had at least a 25% reduction, 16.9% versus 7.2% had at least a 75% reduction, and 12.1% versus 3.2% had no seizures at all during that phase. It is worth noting that more participants in the USL255 group did not complete the trial (21 people) compared with the placebo group (11 people), though the reasons for this were not detailed in the data 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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NCT00520741 · results posted 23 April 2014

According to the results reported on ClinicalTrials.gov, this trial involved 425 people with epilepsy who were taking lacosamide (a seizure medication). Participants were split into two groups: 106 people received 300 mg per day and 319 people received 400 mg per day. The trial was measuring whether lacosamide could be used on its own (as a "monotherapy") rather than alongside other epilepsy medicines — specifically, it tracked how many participants hit certain warning signs (called "exit criteria") within 112 days, such as a significant increase in seizure frequency or a new type of seizure occurring. The reported data shows that for the primary outcome — the percentage of people in the 400 mg group who reached at least one of those warning signs by Day 112 — the figure was 30.0%. The result for the 300 mg group was not reported for this measure. For a broader secondary measure that also counted people who stopped due to side effects or lack of benefit, the reported figure for the 400 mg group was 32.3%. When looking at how long it took participants to first hit a warning sign, the reported median time was 39 days in the 300 mg group and 45 days in the 400 mg group. Both groups spent a reported median of 71 days on lacosamide as the only medication during the monotherapy phase of the study. The reported data also shows how doctors and patients rated overall change compared to the start of the trial. In the 400 mg group, doctors rated 56 participants as "very much improved" and 116 as "much improved," while patients in that group rated 81 as "very much improved" and 93 as "much improved." Smaller numbers in both groups were rated as minimally or much worse. 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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NCT02021461 · results posted 3 April 2014

According to the results reported on ClinicalTrials.gov, this trial involved 38 participants and looked at a liquid form of a medicine called eslicarbazepine acetate (ESL). All 38 participants who started the trial completed it. The trial was not testing whether the medicine treated a condition — instead, it was measuring which of three fruit flavours (banana, grape, or tutti-frutti) children preferred when taking the liquid medicine. Preference was rated using a simple scale from 0 to 10, where a higher number meant a stronger liking for that flavour. The reported data shows that participants rated the banana and grape flavours equally, both scoring 5.8 out of 10 on the preference scale. The tutti-frutti flavour received the highest rating of the three, scoring 7.1 out of 10. No other outcome measures were reported in the submitted data beyond these taste preference scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00437281 · results posted 17 March 2014

According to the results reported on ClinicalTrials.gov, this trial (NCT00437281) tested the medicine pregabalin in children with epilepsy aged from 1 month up to 16 years old. A total of 68 children took part, spread across four age groups and divided into smaller groups that each received a different daily dose of pregabalin (ranging from 2.5 mg to 15 mg per kilogram of body weight per day) or a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring the number and severity of unwanted medical events — called adverse events — that appeared or got worse during treatment. It also looked at how the medicine moved through children's bodies at different ages and doses, and tracked how often seizures occurred. The reported data shows that, during the double-blind treatment period (when neither the children's families nor the researchers knew who was receiving which treatment), the number of recorded adverse events varied across groups. For example, in the youngest age group (1 to 23 months), no adverse events were recorded in the lowest-dose pregabalin group, while 4 were recorded in the highest-dose group and 1 in the placebo group. In the 2–6 year age group, 13 adverse events were recorded in the placebo group compared with 1, 4, 5, and 5 respectively across the four pregabalin dose groups. For physical and neurological check-ups (a secondary measure), only 1 child in the 2–6 year pregabalin group and 1 child in that age group's placebo group were recorded as having a clinically notable change. The reported data for seizure frequency numbers was not provided in the submitted results. Some blood-level measurements of the medicine were also recorded across age and dose groups, but the data was not complete for all subgroups. 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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NCT01682681 · results posted 16 August 2013

According to the results reported on ClinicalTrials.gov, this trial followed 1,234 people who were taking a medicine called topiramate for epilepsy (a condition that causes seizures). Of those, 1,232 actually received the medicine, and 902 completed the full study period of 52 weeks (about one year). The trial was observational — meaning it watched what happened in real-world treatment rather than comparing topiramate against a dummy pill — and it was measuring how many people stayed on the treatment for the full year, as well as tracking seizure patterns along the way. The reported data shows that 71.56% of participants remained on topiramate treatment through to the 52-week mark. In terms of how the medicine was being used, 507 participants were taking it as their very first single epilepsy medicine, 64 were taking it as a second single epilepsy medicine after trying another, and 661 were taking it alongside at least one other epilepsy medicine. The reported data also shows that 749 participants were taking at least one other epilepsy medicine at the same time as topiramate. Regarding seizures, the reported data shows that 40.50% of participants had no seizures recorded during the study period up to Week 52. Additionally, 84.20% of participants were reported to have experienced a reduction in how often their seizures occurred of 50% or more compared to before the study. It is worth noting that this trial had no comparison group, so these figures describe only what was observed in people taking topiramate, without a direct comparison to another treatment or no 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.

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NCT00957047 · results posted 5 August 2013

According to the results reported on ClinicalTrials.gov, this trial (NCT00957047) tested a medicine called eslicarbazepine acetate (ESL) in people with epilepsy who were still having seizures despite other treatments. The trial had two parts. In Part I, around 395 people were randomly assigned to one of four groups: a placebo (dummy treatment) or one of three daily doses of ESL (400 mg, 800 mg, or 1,200 mg). In Part II, a separate group of 325 people received ESL, though 102 of them did not complete that part of the study. The reported data shows that the primary thing measured in Part I was how often seizures occurred over a 12-week period, recorded using a mathematical transformation of the seizure count per four weeks (a way of adjusting the numbers to make them easier to compare statistically). The reported figures were: placebo group, 9.8; ESL 400 mg group, 8.7; ESL 800 mg group, 7.1; and ESL 1,200 mg group, 7.0. Lower numbers in this measurement correspond to fewer seizures per four weeks. In Part II, the trial tracked unwanted medical events (called adverse events) experienced by the 325 participants taking ESL. The reported data shows that 270 out of 325 participants experienced at least one such event; 194 were considered treatment-related; 37 led to stopping the study; 28 were classified as serious; and 3 participants died during the study period. The data does not provide further breakdown of those deaths or their relationship to the 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.

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NCT00510783 · results posted 5 August 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 158 people in total — 82 in one group who received phenytoin or fosphenytoin, and 76 in another group who received levetiracetam. These are all medicines that can be given in an emergency setting. The trial was measuring how many people in each group had another seizure within 24 hours of being treated in the Emergency Department. Not everyone completed the study — 51 people in the first group and 47 in the second group were recorded as completing it, while 31 and 29 respectively did not complete it (the reasons for this were not reported in the data provided). The reported data shows that, of those treated, 2 out of 82 participants in the phenytoin/fosphenytoin group experienced a repeat seizure within 24 hours of their Emergency Department treatment. In the levetiracetam group, 3 out of 76 participants experienced a repeat seizure within the same 24-hour window. No other outcome measures were included in the data submitted to 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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NCT00610532 · results posted 14 May 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled a small number of participants — all placed in a single group — who went through two treatment periods. In the first period, 8 participants received intravenous phenytoin (a medication commonly used for seizures) on its own, and all 8 completed it. In the second period, 7 participants received intravenous phenytoin together with probenecid (a medication that can affect how other drugs move through the body), and all 7 completed that period. The trial was measuring brain activity using quantitative EEG recordings — a method that uses sensors on the scalp to detect and measure electrical signals in the brain. The reported data shows that, for the primary outcome measure — those quantitative EEG recordings — no numerical results were submitted to ClinicalTrials.gov. The measurement fields are empty, meaning the actual figures were not reported in the structured results data available. As a result, it is not possible to describe what the EEG recordings showed in numbers. No secondary outcome measures were listed in the submitted data either. 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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NCT00477295 · results posted 8 February 2013

According to the results reported on ClinicalTrials.gov, this trial compared two medications — zonisamide and carbamazepine — in people with epilepsy. A total of 282 people were assigned to the zonisamide group and 301 to the carbamazepine group, making 583 participants in all. The trial's main goal was to measure how many people in each group went a full 26 weeks (about six months) without having any seizures during a set maintenance phase of the study. The reported data shows that, for the primary measure, 79.4% of participants in the zonisamide group and 83.7% in the carbamazepine group achieved 26 weeks without a seizure during the maintenance phase. For a longer seizure-free stretch of 12 months across the full treatment period, the reported figures were 67.6% for the zonisamide group and 74.7% for the carbamazepine group. The trial also tracked how long it took participants to first reach six months seizure-free, which was reported as an average of roughly 222.7 days for the zonisamide group and 220.4 days for the carbamazepine group. For reaching 12 months seizure-free, the reported averages were approximately 399.3 days and 395.6 days respectively. Regarding the time until people dropped out due to unwanted medical events (side effects), median figures were not reported for either group. For dropping out due to the treatment not controlling seizures well enough, a median of 722 days was reported for the zonisamide group, while this figure was not reported for the carbamazepine 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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NCT00849212 · results posted 7 February 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 30 people who were given a medicine called perampanel. The trial was looking at two main things: the highest dose of perampanel each person could tolerate (called the Maximum Tolerated Dose, or MTD — meaning the highest amount someone could take before side effects became too much), and whether the number of seizures they experienced changed compared to before the trial. Of the 30 people who started, 23 completed the trial and 7 did not finish. The reported data shows how many participants reached each dose level of perampanel as their maximum tolerated dose. According to the results reported on ClinicalTrials.gov, no participants had their MTD recorded at the lowest dose level, 2 participants reached the second dose level, 1 reached the third, 6 reached the fourth, 6 reached the fifth, 5 reached the sixth, and 10 participants reached the highest dose level. The specific dose amounts for each level were not included in the data provided here. For the secondary outcome, the reported data shows that, on average, participants experienced a 35% reduction in total seizure frequency per 28 days during the maintenance period of the trial, compared to their seizure frequency before the trial began. This figure was calculated using a standard method called "last observation carried forward," which fills in missing data using each person's most recent recorded 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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NCT01235403 · results posted 24 January 2013

According to the results reported on ClinicalTrials.gov, this trial enrolled 100 people who were given a medication called lacosamide (brand name Vimpat). The study ran in phases over roughly 24 weeks — a 12-week period where the dose was gradually increased, followed by a 12-week period where the dose was kept steady, and then a short wind-down phase of 3 to 4 weeks if needed. Of the 100 people who started, 74 completed the study and 26 did not. The reported data shows that the two main things the trial was measuring were how many participants experienced at least one "treatment-emergent adverse event" (meaning any unwanted health event that appeared or worsened after starting the medication) and how many stopped the study early because of such an event. According to the results reported on ClinicalTrials.gov, 64 out of 100 participants reported at least one such event during the study, and 14 out of 100 participants left the study early because of one. The trial also measured what percentage of participants were still taking lacosamide at the end of the full 24-week treatment period — the reported figure was 73%. 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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NCT00848549 · results posted 15 January 2013

According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants — 282 people were given zonisamide and 301 were given carbamazepine — both medicines used for epilepsy. The trial was made up of a base study followed by an extension phase, and it was measuring how long people stayed on their assigned treatment, how many remained free of seizures over a long period, and how participants rated their quality of life. In total, 295 people entered the extension phase (137 on zonisamide, 158 on carbamazepine). The reported data shows that the main thing being tracked was the percentage of participants still in the extension study at each check-in point over time. Both groups saw similar gradual drops in the number of people remaining: by the final reported visit, approximately 27.7% of the zonisamide group and 27.8% of the carbamazepine group were still participating. For the secondary measures, the average time until someone left the study due to poor seizure control was reported as around 298 days for zonisamide and 289 days for carbamazepine. The average time until someone left due to an unwanted health change (called an adverse event) was reported as around 132 days for zonisamide and 97 days for carbamazepine. Regarding seizure freedom over a continuous 24-month period, the reported data shows 32.3% of the zonisamide group and 35.2% of the carbamazepine group met this measure. The reported data also shows that both groups recorded improvements in their quality-of-life scores (on a 0–100 scale where higher means better) at most time points during the extension phase, though the pattern of change varied between visits and between the two groups. For some visits the carbamazepine group reported larger improvements, and for at least one visit the zonisamide group's score showed a very small negative change, meaning a slight dip compared to where they started. It is worth noting that quality-of-life data was only available for those who remained in the study at each time point, and numbers of participants at later visits were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00448539 · results posted 10 December 2012

According to the results reported on ClinicalTrials.gov, this trial involved 286 people in total — 134 who had taken rufinamide during an earlier part of the study, and 152 who had taken a placebo (a dummy treatment) during that earlier part. Both groups then went on to receive rufinamide in this open-label phase (meaning everyone knew what treatment was being given). The trial was measuring how much the frequency of partial seizures — a type of seizure that affects only part of the brain — changed compared to each participant's starting level before the study began. The reported data shows the results as a percentage change in how often partial seizures occurred over every 28-day period. For the group that had been on rufinamide in the earlier study, the reported figures show a reduction of around 35.65% and 30.95% at different time points during this phase. For the group that had previously been on placebo, the reported figures show reductions of around 45.10% and 31.10% at those same time points. The data does not include enough detail to clarify exactly when each of these measurements was taken, so a full picture of the timing is not available from what was reported. It is worth noting that the data shows zero participants recorded as having "completed" the study in the formal sense, with all 286 listed under "not completed" — the reasons for this are not explained in the submitted data, so no further detail can be provided on that point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01689649 · results posted 21 November 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 139 participants, all of whom received the medication topiramate. Of those, 117 people completed the study, while 22 did not finish. The trial was measuring how topiramate affected the frequency of epileptic seizures in participants, looking specifically at how many people experienced meaningful reductions in their seizure numbers over the last four months of treatment. The reported data shows several results for the main (primary) outcome measures, though the data as submitted contains multiple figures per outcome that appear to relate to different sub-groups or time points within the study — the labelling for these sub-groups was not clearly specified in the submitted data. For seizure-free participants during the last four months, the reported figures were 58.6%, 67.0%, and 70.0% across the reported categories. For those with a 75% or greater reduction in seizures, the figures were 20.3%, 16.9%, and 16.0%. For those with a 50% or greater reduction in seizures, the figures were 7.0%, 2.4%, and 3.0%. Because the sub-group labels were not fully specified in the submitted data, a more detailed breakdown cannot be described here without risk of misrepresenting the numbers. The reported data also shows results for secondary outcomes, including seizure reductions broken down by seizure type (partial, secondarily generalised, and generalised tonic-clonic) and by how frequently seizures occurred before treatment. Additionally, a clinical impression scale was used to rate participants' overall condition before and after treatment — the reported data shows that 0% were rated "very good" before treatment compared to 17.9% after, and 44.9% were rated "medium" before treatment compared to 1.6% after, among other categories. These numbers describe what was observed and recorded in this trial 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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NCT00692003 · results posted 12 October 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT00692003) was comparing zonisamide against a placebo (an inactive treatment) in people with a type of epilepsy involving seizures called Primary Generalised Tonic-Clonic Seizures (PGTCS) — these are seizures that affect the whole brain and cause the body to stiffen and jerk. The trial set out to measure two things: first, how many participants had their seizure frequency cut by at least half during a 12-week maintenance period (the main goal); and second, how much the number of seizures per 28 days changed from the starting point (a secondary goal). In total, only six people were enrolled — five in the zonisamide group and one in the placebo group — and none of them completed the study. The reported data shows that the trial was ended early by the company running it (the sponsor). Because of this early termination, the data for both the primary and secondary outcome measures was not reported — no numbers were submitted for either the responder count or the change in seizure frequency. According to the results reported on ClinicalTrials.gov, no formal analyses were conducted on any of the outcomes. As a result, no conclusions can be drawn from this trial's numbers, because the data simply was not collected or reported in a way that allows any comparison between the zonisamide and placebo 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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NCT00693017 · results posted 12 September 2012

According to the results reported on ClinicalTrials.gov, this trial (NCT00693017) was comparing a medicine called zonisamide against a placebo (an inactive dummy treatment) in people with myoclonic seizures — a type of seizure involving sudden, brief muscle jerks. The trial planned to measure how many participants had at least a 50% reduction in the number of days per month they experienced myoclonic seizures, as well as the overall percentage change in those seizure days. A total of four people were enrolled — two in the zonisamide group and two in the placebo group. The reported data shows that none of the four participants completed the study. According to the results reported on ClinicalTrials.gov, the sponsor ended the trial early, and as a result, no formal analysis of the results was carried out. The data submitted shows no numerical results for either the primary outcome (the number of participants whose seizures reduced by 50% or more) or the secondary outcome (the percentage change in monthly seizure days) — these figures were simply not reported. Because the trial was stopped so early and with so few participants, the submitted data contains no outcome numbers to describe for either group. The reported data shows only that the study did not reach a point where its planned measurements could be meaningfully 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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NCT01063764 · results posted 19 June 2012

According to the results reported on ClinicalTrials.gov, this trial involved a single group of participants who were all given a medicine called levetiracetam, which is used for a type of epilepsy involving partial seizures (seizures that start in one part of the brain). A total of 73 people entered the first part of the study, with 62 completing it. In the second, longer-term part of the study — which ran for up to three years — 55 people started and 35 completed it. The trial was measuring changes in how often participants experienced partial seizures compared to before treatment began, as well as tracking any unwanted medical events that occurred during the study. The reported data shows that over the first 14-week treatment period, the average reduction in weekly partial seizure frequency was about 43%, meaning that on average, participants had roughly 43 out of every 100 seizures fewer per week compared to their starting point. During a shorter 10-week evaluation window within that period, the reported reduction was around 39%. The reported average number of partial seizures per week during both the 14-week and 10-week periods was approximately 3.9 seizures per week. Around 38% of participants were recorded as having had at least a 50% drop in their weekly seizure count during the 14-week treatment period. Regarding unwanted medical events, the reported data shows that 98.2% of participants in the longer second period experienced at least one treatment-emergent adverse event — that is, any untoward medical occurrence that happened after starting the medicine, though this does not necessarily mean the medicine caused it. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00162981 · results posted 9 February 2012

According to the results reported on ClinicalTrials.gov, this trial involved 68 participants in total — 32 in a low-dose group and 36 in a high-dose group — all of whom were taking a medicine called clobazam. The trial was measuring changes in the number of "drop seizures" (a type of seizure where the person suddenly loses muscle control and falls), tracked using seizure diaries kept by patients or their carers. By the end of the study, 28 people in the low-dose group and 30 in the high-dose group had completed the trial, with 4 and 6 participants respectively not completing it. The reported data shows that, for the primary outcome — the percentage reduction in weekly drop seizures — the low-dose group had an average reduction of 10.1%, while the high-dose group had an average reduction of 85.2%. A second primary measure comparing the two groups directly reported reductions of 29% for the low-dose group and 93% for the high-dose group. For secondary outcomes, the trial also looked at what proportion of participants had reductions of at least 25%, 50%, 75%, or 100% in drop seizures. The reported data shows that in the low-dose group, 18%, 12%, 7%, and 2% of participants reached those thresholds respectively, compared with 32%, 30%, 23%, and 8% in the high-dose group. Carers and parents were also asked to rate the overall change in the patient's symptoms. The reported data shows that in the high-dose group, 15 carers rated patients as "very much improved" and another 15 as "much improved," while in the low-dose group, 7 rated patients as "very much improved" and 9 as "much improved." Ratings of "minimally improved" or "no change" were more common in the low-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.

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NCT00518713 · results posted 9 February 2012

According to the results reported on ClinicalTrials.gov, this trial enrolled 238 people in total across four groups: a low dose of clobazam (58 people), a medium dose of clobazam (62 people), a high dose of clobazam (59 people), and a placebo — a dummy treatment with no active ingredient — (59 people). The trial was studying a type of seizure called "drop seizures" in people with a seizure condition, and it measured whether the number of these seizures per week changed over a 12-week period. Participants or their carers kept a diary to record seizures throughout the study. The reported data shows that over the full 12-week period, the average weekly number of drop seizures fell by 41.2% in the low-dose group, 49.4% in the medium-dose group, and 68.3% in the high-dose group, compared with 12.1% in the placebo group. When looking at just the first four weeks, the reported reductions were 47.8% (low dose), 58.9% (medium dose), 71.0% (high dose), and 18.6% (placebo). The reported data also shows that over the full 12 weeks, between 34% and 46% of participants in the clobazam groups had at least a 25% drop in seizures, compared with 28% in the placebo group; and between 15% and 31% of clobazam participants had at least a 75% drop in seizures, compared with 6% in the placebo group. Not all participants completed the study — between 8 and 18 people per 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.

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NCT00367432 · results posted 16 January 2012

According to the results reported on ClinicalTrials.gov, this trial followed people taking a medicine called levetiracetam for a type of epilepsy involving partial seizures (seizures that start in one part of the brain). The trial had two phases: a first period lasting 16 weeks, and a longer follow-up period of up to 54 months. A total of 313 people entered the first phase, and 275 went on to the longer phase. A second group of 85 people, who had taken part in a separate but related trial, also joined the longer phase. Across both groups combined, 381 participants were included in the main safety-related measurement. The reported data shows that the primary thing being tracked was the number of people who experienced at least one unexpected medical event (called an "adverse event") while taking the medicine — 381 participants were reported to have had at least one such event during the study. For the secondary measurements, which looked at seizure counts, the reported data shows that during the first 16-week period, participants averaged about 2.13 partial seizures per week. The reported figures also show an average reduction of around 22% in overall partial seizure frequency compared to where participants started. Breaking that down further, simple partial seizures showed a reported average reduction of about 40%, while complex partial seizures showed a reported average reduction of about 21%. Additionally, 74 out of 313 participants were reported to have had their partial seizure frequency reduce by at least half during that first period, while 239 did not reach that level of reduction. 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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NCT00235755 · results posted 7 November 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 539 adults with partial seizures (also called focal seizures — seizures that start in one specific area of the brain). Participants were randomly assigned to one of three groups: a placebo (a dummy treatment with no active ingredient), a lower dose of retigabine (200 mg three times a day), or a higher dose of retigabine (300 mg three times a day). The trial ran in two phases — a four-week period where doses were gradually increased, followed by a 12-week period where doses were kept steady. The main things being measured were how much participants' seizure frequency changed compared to before the trial started, and how many participants had their seizures cut by at least half. The reported data shows that, looking at the change in how often seizures occurred across the full double-blind period, the placebo group had a reported average reduction of about 15.9%, the lower-dose retigabine group had a reported average reduction of about 27.9%, and the higher-dose retigabine group had a reported average reduction of about 39.9%. Negative numbers here mean fewer seizures were recorded compared to baseline. For the question of how many people had their seizures cut by at least half during the maintenance phase, the reported figures were 31 out of 164 in the placebo group, 61 out of 158 in the lower-dose group, and 70 out of 149 in the higher-dose group. A number of secondary measures were also reported, including similar breakdowns for different levels of seizure reduction, all of which are available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00515619 · results posted 9 September 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 376 adults who took a medicine called lacosamide for partial onset seizures (a type of epilepsy where seizures start in one part of the brain). There was only one group in this study — everyone received lacosamide — and participants were followed for up to 5.5 years. Of the 376 who started, 160 completed the full study period, while 216 did not finish. The reported data shows that the primary outcomes focused on tracking unwanted medical events (called adverse events) that occurred during treatment. Out of 376 participants, 311 experienced at least one such event during the study period, and 33 people stopped taking the medicine early because of one. A total of 87 participants experienced what is classified as a "serious" adverse event — meaning something that led to hospitalisation, was life-threatening, caused significant disability, or was considered an important medical concern. It is important to note that these events were recorded regardless of whether they were considered related to the medicine itself. The reported data also shows two secondary outcomes related to seizure frequency. The middle value (median) percentage change in seizures — measured over 28-day periods compared to before the study — was reported as a reduction of 49.9%. A negative number here means fewer seizures were recorded on average. Separately, 50% of participants were reported to have experienced at least a 50% reduction in their seizure frequency during the treatment period compared to their starting point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT00552305 · results posted 2 September 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 370 people, all of whom received a medicine called lacosamide. It was a long-term follow-on study lasting up to 8 years, and it was primarily tracking what unwanted medical events (called adverse events) occurred while participants were taking the medicine. Of the 370 people who started, 120 completed the study and 250 did not finish for various reasons. The reported data shows that 343 out of 370 participants experienced at least one unwanted medical event during the treatment period. Of those, 47 people stopped taking the medicine early because of such an event. Separately, 125 participants experienced what is classified as a "serious" adverse event — meaning a medical occurrence that led to outcomes such as hospitalisation, was life-threatening, or caused significant disability, among other criteria. It is important to note that these events were recorded whether or not they were considered related to the medicine itself. The reported data also shows results for two secondary measures related to seizure frequency. The middle value (median) percentage change in seizures over a 28-day period, compared to before the study, was reported as −50.8%, where a negative number indicates a reduction in seizures. Additionally, just over half of participants — 51.2% — were reported to have had their seizure frequency reduce by at least 50% compared to their starting point. These figures describe what was recorded across the study group as a whole. 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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NCT00655486 · results posted 15 July 2011

According to the results reported on ClinicalTrials.gov, this trial looked at lacosamide, a medication used for epilepsy, in an open-label extension study — meaning all participants knew they were receiving the treatment, and the study followed on from an earlier trial. A total of 97 people took part, and the study ran for up to two years. By the end, 69 participants had completed the study, while 28 did not finish for various reasons. The main things the trial was measuring were how many participants experienced any unwanted medical events (called adverse events) during the study, and how many left the study early because of such events. The reported data shows that out of 97 participants, 93 experienced at least one adverse event at some point during the study period. It is important to note that in clinical trials, an "adverse event" refers to any unwanted medical occurrence that happens during the study — it does not necessarily mean the event was caused by the medication. The reported data also shows that 10 participants withdrew from the study because of an adverse event. No other outcome figures were included in the data submitted to 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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NCT00922987 · results posted 21 June 2011

According to the results reported on ClinicalTrials.gov, this trial enrolled 281 adults who were already taking pregabalin for partial seizures (a type of epilepsy where abnormal electrical activity starts in one part of the brain). All participants were in a single group receiving pregabalin, meaning there was no comparison or placebo group. The trial measured how often partial seizures occurred over a 28-day period, comparing counts before the treatment phase began (the "baseline") to counts during the main treatment period (weeks 4 to 16). Of the 281 who started, 277 completed the study and 4 did not. The reported data shows that for the primary outcome — the proportion of participants whose 28-day partial seizure count fell by at least half compared to their baseline — the reported figure was 85%. For one of the secondary outcomes, the reported median percentage change in seizure frequency at the final visit was −100%, meaning that figure reflects the middle point of the group's results. The reported data also shows that 172 out of 281 participants recorded no seizures of any kind during the last four weeks of the study. On an anxiety scale running from 0 (no anxiety) to 100 (extreme anxiety), the average starting score was reported as approximately 54 mm, which dropped by around 14 mm at week 4 and by around 26 mm by the final visit. Doctors also rated participants' overall condition on standard clinical scales; the reported data shows that at the final visit, 243 out of 273 participants with available data were rated as showing some degree of improvement, 29 were rated as showing no change, and 1 was rated as having worsened. 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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NCT00047463 · results posted 3 May 2011

According to the results reported on ClinicalTrials.gov, this trial involved 35 people in total — 13 in the placebo CPAP group and 22 in the active CPAP group. The trial was looking at a breathing device called CPAP (Continuous Positive Airway Pressure), which is commonly used for sleep apnoea. The main thing the researchers were measuring was how consistently participants used their device over a 10-week period, by tracking how many nights it was actually switched on. A secondary goal was to check whether participants could tell if they were using the real device or a placebo (dummy) version that felt similar but did not deliver the same treatment. The reported data shows that, on average, people in the placebo CPAP group used their device on about 74% of nights, while people in the active CPAP group used theirs on about 66% of nights. The reported data also shows that all 22 participants in the active CPAP group and all 13 in the placebo group were successfully kept unaware of which type of device they had received — meaning the blinding appeared to hold across both groups. Additionally, the reported data shows that 39 participants (all those who took part before being assigned to a group) needed only one night of sleep testing to detect sleep apnoea before the study began. It is worth noting that three participants in the active CPAP group did not complete the study, though the reasons were not detailed in the data provided here. No data on any other outcomes were reported in this submission. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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NCT01064297 · results posted 11 October 2010

According to the results reported on ClinicalTrials.gov, this trial followed pregnant women who were taking the medication lamotrigine (a medicine commonly used for epilepsy and some mood conditions) to track what happened during their pregnancies. The women were divided into three groups: those taking lamotrigine on its own (monotherapy), those taking it alongside another medicine called valproate, and those taking it alongside other medicines but not valproate. In total, 2,567 pregnancies were enrolled in the monotherapy group, 219 in the lamotrigine-plus-valproate group, and 630 in the lamotrigine-plus-other-medicines group. The trial was measuring birth outcomes — such as live births, pregnancy losses, and induced terminations — as well as how many babies were born with major birth differences (called major congenital malformations, meaning significant physical differences present at birth). The reported data shows the following birth outcome numbers for the monotherapy group: 31 fetal deaths (pregnancy losses at or after 20 weeks) where first exposure was in the first trimester, 1 in the second trimester, and 3 induced terminations in the first trimester. For the lamotrigine-plus-valproate group, 14 fetal deaths were reported where first exposure was in the first trimester, with 2 induced terminations in that same trimester. For the lamotrigine-plus-other-medicines group, the reported data shows 418 live births with first trimester exposure, 25 in the second trimester, and 2 in the third trimester. Regarding major birth differences, the reported data shows 40 infants across all trimesters in the monotherapy group, 1 in the lamotrigine-plus-valproate group, and 13 in the lamotrigine-plus-other-medicines group. It is worth noting that the trial's own descriptions flag that birth differences may not always have been consistently identified or reported across all pregnancy outcome types, and some figures were not reported for certain subgroups. 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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NCT01061866 · results posted 3 February 2010

According to the results reported on ClinicalTrials.gov, this trial enrolled 7 participants, all of whom received thalidomide. The trial was measuring whether there was a change in the number of seizures participants experienced each day, comparing how many they had at the start of the trial to how many they had after one year. Five participants completed the trial, while two did not finish. The reported data shows one primary outcome measure: the change in the average number of daily seizures from the beginning of the trial to the one-year mark. The number reported for this measure was 9 seizures. It is worth noting that the data as submitted does not include a baseline (starting point) figure or a clear breakdown of how this number was calculated, so it is not possible to describe the full picture of change over time from the information 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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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.