Trial 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
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.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Epilepsy Trial, Completed
Who may be able to join
AI generated eligibility 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
Who might be able to join this trial:
- You or your child has been formally diagnosed with Dravet Syndrome (DS).
- There have been 12 or more convulsive (tonic-clonic or other major) seizures in the 12 weeks before the screening visit, and at least 4 convulsive seizures per 28 days during a 4- to 6-week observation period before the trial starts.
- You or your child weighs at least 10 kg (about 22 lbs) at the first screening visit.
- Seizures have not been fully controlled despite trying at least one anti-seizure medication, and you or your child is currently taking an anti-seizure medication or other standard treatment.
- If taking artisanal (non-prescription) CBD products, the dose must have been stable for at least 4 weeks before screening, and the same product and dose must be kept throughout the study.
- You or your child is currently taking between 0 and 4 anti-seizure medications at stable doses for at least 4 weeks before screening (certain medications like fenfluramine and prescription cannabidiol/Epidiolex count toward this limit where available).
Who may not be able to join:
- You or your child has another serious or unstable medical condition — such as a significant heart, lung, liver, kidney, neurological, psychiatric, or other major health problem — that could affect participation in the study or make it harder to interpret the results (confirm with trial site).
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Study Director, Takeda
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
1 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Full Treatment Period; Percent Change From Baseline in Convulsive Seizure Frequency Per 28 Days During the Maintenance Period
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.