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NCT04940624 · ClinicalTrials.gov registry record · Phase 3
A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
A Phase 3 study of Dravet Syndrome (DS), sponsored by Takeda.
- Completed
- Registry status
- Phase 3
- Development phase
- 144
- Enrollment target
- 20
- Study locations
NCT04940624: Completed Phase 3 study of Dravet Syndrome (DS), sponsored by Takeda.
NCT04940624 is a Phase 3 study of Dravet Syndrome (DS) that has completed, run by Takeda. The registered enrollment target is 144 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04940624, a Phase 3 study of Dravet Syndrome (DS), has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 144 participants
- Enrollment target
- 20
- Study locations
Study Summary
The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo looks just like soticlestat but will not have any medicine in it. Participants may continue treatment in an extension study, based on the extension study's entry criteria. Those that want to stop treatment will have a gradual dose reduction during 1 week and then be followed up for 2 weeks.
Primary Outcome
Convulsive seizure frequency per 28 days was defined as the total number of convulsive seizures reported during the period divided by the number of days during the period seizures were assessed multiplied by 28. Percent change from Baseline was defined as (frequency of seizures per 28 days during the Full Treatment Period - frequency of seizures per 28 days at Baseline) divided by the frequency of seizures per 28 days at Baseline multiplied by 100.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Soticlestat
Study Locations (20)
California
- David Geffen School of Medicine at UCLA - Los Angeles
- University of California Benioff Children's Hospital - San Francisco
Washington
- Seattle Children's Hospital - Seattle
- Multicare Health System - Mary Bridge Pediatrics - Tacoma
Beijing Municipality
- Peking University First Hospital - Beijing
- Beijing Children's Hospital,Capital Medical University - Beijing
Arizona
- Phoenix Childrens Hospital - Phoenix
Georgia
- Clinical Integrative Research Center of Atlanta - Atlanta
Iowa
- University of Iowa Hospitals & Clinics - (CRS) - Iowa City
New York
- NYU Comprehensive Epilepsy Center - New York
Ohio
- University of Toledo - Toledo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 144 participants |
| Start Date | 2021-10-28 |
| Est. Completion | 2024-04-11 |
| Phase | Phase 3 |
What the finished NCT04940624 record still lists
NCT04940624 is an interventional study that assigns participants to a tested intervention. The registered 144 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 1 condition, with Dravet Syndrome (DS) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04940624 names 20 study sites across 17 states, led by California, Washington, Beijing Municipality.
Frequently Asked Questions
What is clinical trial NCT04940624 about?
NCT04940624 is a clinical study titled "A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome". The main aim of the study is to learn if soticlestat, when given as an add-on therapy, reduces the number of convulsive seizures in children and young adults with DS. Participants will receive their standard antiseizure therapy, plus either a tablet of soticlestat or placebo for 16 weeks. A placebo...
What is the current status of trial NCT04940624?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 144 participants. The study started on 2021-10-28. Estimated completion is 2024-04-11.
What conditions does trial NCT04940624 study?
This clinical trial studies the following conditions: Dravet Syndrome (DS).
What interventions are being tested in trial NCT04940624?
The interventions under investigation include: Placebo (DRUG), Soticlestat (DRUG).
Who is sponsoring clinical trial NCT04940624?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04940624 being conducted?
This trial has 20 study locations across Arizona, California, Georgia, Iowa, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Dravet Syndrome (DS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04940624's enrollment target sits among peer trials
144 1559th of 2000 higher than 442 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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