A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
Public ClinicalTrials.gov record NCT04938427. 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 Adult Subjects With Lennox-Gastaut Syndrome (LGS)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The aims of the study are: * to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome. * to assess the safety profile of soticlestat when given in combination with other therapies. Participants will receive their standard antiseizure therapy, plus either tablets of soticlestat or placebo. A placebo looks just like soticlestat but will not have any medicine in it. Participants will take soticlestat or placebo for 16 weeks, followed by a gradual dose reduction for 1 week. Then, participants will be followed up for 2 weeks.
Study identification
- NCT ID
- NCT04938427
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 270 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 2 Years to 55 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
- Nov 8, 2021 (Actual)
- Primary completion
- Jan 25, 2024 (Actual)
- Completion
- Jan 25, 2024 (Actual)
- Last update posted
- Sep 10, 2026
2021 – 2024
United States locations
- U.S. sites
- 24
- U.S. states
- 16
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Phoenix Childrens Hospital | Phoenix | Arizona | 85016 | — |
| Center For Neurosciences | Tucson | Arizona | 85718 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095 | — |
| University of California Benioff Children's Hospital | San Francisco | California | 94143 | — |
| Children's Hospital Colorado. | Denver | Colorado | 80218 | — |
| Pediatric Neurology PA | Winter Park | Florida | 32789 | — |
| Clinical Integrative Research Center of Atlanta | Atlanta | Georgia | 30328 | — |
| University of Iowa Hospitals & Clinics - (CRS) | Iowa City | Iowa | 52242 | — |
| Midatlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | — |
| Minnesota Epilepsy Group PA | Roseville | Minnesota | 55113 | — |
| Institute of Neurology and Neurosurgery at Saint Barnabas, LLC | Livingston | New Jersey | 07039 | — |
| Premier Healthcare Inc. | New York | New York | 10001 | — |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | — |
| Northwell Health Physician Partners - Neurology at Lenox Hill | New York | New York | 10075 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| St. Christopher's Hospital for Children | Philadelphia | Pennsylvania | 19134 | — |
| WellSpan Oncology Research | York | Pennsylvania | 17403 | — |
| Medical University of South Carolina Children Hospital - PIN | Charleston | South Carolina | 29425 | — |
| Cook Children's Medical Center - Jane and John Justin Neurosciences Center | Fort Worth | Texas | 76104 | — |
| University of Utah - Primary Children's Hospital - PPDS | Salt Lake City | Utah | 84113 | — |
| Seattle Children's Hospital | Seattle | Washington | 98105 | — |
| MultiCare Institute for Research & Innovation (Tacoma) | Tacoma | Washington | 98402 | — |
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 74 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04938427, 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 10, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04938427 live on ClinicalTrials.gov.