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A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
NCT04940624 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04940624
The ClinicalTrials.gov registry entry for NCT04940624 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 144 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 387 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04940624 reports 20 study locations spanning 17 distinct geographic areas — top geographies include California, Washington, Beijing Municipality. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04940624?
The interventions under investigation include: Placebo (DRUG), Soticlestat (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04940624?
This trial is sponsored by Takeda, which has 387 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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