A Study of Soticlestat as an Add-on Therapy in Children and Young Adults With Dravet Syndrome
Public ClinicalTrials.gov record NCT04940624. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy, Safety, and Tolerability of Soticlestat as Adjunctive Therapy in Pediatric and Young Adult Subjects With Dravet Syndrome (DS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04940624
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 144 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 21 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 27, 2021
- Primary completion
- Apr 10, 2024
- Completion
- Apr 10, 2024
- Last update posted
- Sep 3, 2026
2021 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016-7710 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095-3075 | — |
| University of California Benioff Children's Hospital | San Francisco | California | 94143-2350 | — |
| Clinical Integrative Research Center of Atlanta | Atlanta | Georgia | 30328 | — |
| University of Iowa Hospitals & Clinics - (CRS) | Iowa City | Iowa | 52242-1009 | — |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | — |
| University of Toledo | Toledo | Ohio | 43606-3818 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105-3901 | — |
| Multicare Health System - Mary Bridge Pediatrics | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 56 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04940624, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Sep 6, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04940624 live on ClinicalTrials.gov.