A Study of Soticlestat as an Add-on Therapy in Children and Adults With Dravet Syndrome or Lennox-Gastaut Syndrome
Public ClinicalTrials.gov record NCT05163314. 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 Phase 3, Prospective, Open-Label, Multisite, Extension of Phase 3 Studies To Assess the Long-Term Safety and Tolerability of Soticlestat as Adjunctive Therapy in Subjects With Dravet Syndrome or Lennox-Gastaut Syndrome (ENDYMION 2)
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 seizures in children and adults with Dravet Syndrome (DS) or Lennox-Gastaut Syndrome (LGS). Participants will receive their standard anti-seizure therapy, plus tablets of soticlestat. There will be scheduled visits and follow-up phone calls throughout the study.
Study identification
- NCT ID
- NCT05163314
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 352 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 2 Years to 56 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
- Mar 4, 2022 (Actual)
- Primary completion
- Sep 24, 2025 (Actual)
- Completion
- Sep 24, 2025 (Actual)
- Last update posted
- Sep 4, 2026
2022 – 2025
United States locations
- U.S. sites
- 26
- U.S. states
- 17
- U.S. cities
- 22
| 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 | — |
| Colorado Children's Hospital | Denver | Colorado | 80218 | — |
| Pediatric Neurology PA | Winter Park | Florida | 32789 | — |
| Clinical Integrative Research Center of Atlanta | Atlanta | Georgia | 30328 | — |
| Sunrise Pediatric Neurology | Marietta | Georgia | 30066 | — |
| University of Iowa Hospitals & Clinics - (CRS) | Iowa City | Iowa | 52242 | — |
| Midatlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | — |
| Minnesota Epilepsy Group PA | Saint Paul | Minnesota | 55102 | — |
| Institute of Neurology and Neurosurgery at Saint Barnabas, LLC | Livingston | New Jersey | 07039 | — |
| Boston Children's Health Physicians (BCHP) | New York | New York | 10003 | — |
| Northwell Health Physician Partners - Neurology at Lenox Hill | New York | New York | 10016 | — |
| NYU Comprehensive Epilepsy Center | New York | New York | 10016 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| 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 90 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05163314, 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 4, 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 NCT05163314 live on ClinicalTrials.gov.