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 (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.
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) have been formally diagnosed with Lennox-Gastaut Syndrome (LGS).
- You (or your child) have had at least 8 "drop" seizures (sudden falls or collapses caused by seizures) per month for the 3 months before the screening visit, and this continues during a 4–6 week monitoring period before the trial starts.
- You (or your child) weigh at least 10 kg (approximately 22 lbs) at the first screening visit.
- Seizures have not been fully controlled despite trying at least one approved anti-seizure medication, and you (or your child) are currently on at least one seizure treatment.
- You (or your child) are currently taking between 0 and 3 anti-seizure medications at a steady, unchanged dose for at least 4 weeks before screening — certain medications including fenfluramine and prescription cannabidiol (Epidiolex) are allowed and count toward this number.
- If you (or your child) use non-prescription CBD (artisanal cannabidiol), this is allowed if the dose and brand have been stable for at least 4 weeks before screening and stay the same throughout the study.
Who may not be able to join:
- You (or your child) have been hospitalised and placed on a breathing machine 2 or more times in the 3 months before screening due to a severe, prolonged seizure episode (confirm with trial site).
- You (or your child) have another serious, unstable medical condition — such as heart, liver, kidney, lung, or psychiatric problems — that could affect safe participation in the study or affect the results (confirm with trial site).
- You (or your child) are considered to be at immediate risk of self-harm or harm to others, or have made a suicide attempt in the 12 months before screening — for participants aged 6 and older, a standard safety questionnaire will also be used to assess this.
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: Medical 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
4 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Full Treatment Period; Percent Change From Baseline in Major Motor Drop (MMD) Seizure Frequency Per 28 Days During the Maintenance Period
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.