A Study of Soticlestat in Adults and Children With Rare Epilepsies
Public ClinicalTrials.gov record NCT03635073. 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 2, Prospective, Interventional, Open-Label, Multi-Site, Extension Study to Assess the Long-Term Safety and Tolerability of Soticlestat (TAK-935) as Adjunctive Therapy in Subjects With Developmental Epileptic Encephalopathies Including Dravet Syndrome, Lennox Gastaut Syndrome, CDKL5 Deficiency Disorder, and Chromosome 15 Duplication Syndrome (ENDYMION 1)
Study identification
- NCT ID
- NCT03635073
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Lead sponsor
- Takeda
- Industry
- Enrollment
- 156 participants
Conditions and interventions
Interventions
- Soticlestat Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years and older
- 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
- Jul 18, 2018
- Primary completion
- Jul 29, 2025
- Completion
- Jul 29, 2025
- Last update posted
- Mar 18, 2026
2018 – 2025
United States locations
- U.S. sites
- 27
- U.S. states
- 15
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Xenosciences Inc | Phoenix | Arizona | 85004 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 900095-1752 | — |
| David Geffen School of Medicine at UCLA | Los Angeles | California | 90095-8358 | — |
| Colorado Children's Hospital | Aurora | Colorado | 80045-7106 | — |
| Colorado Children's Hospital | Aurora | Colorado | 80045 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155-3009 | — |
| Nicklaus Children's Hospital | Miami | Florida | 33155 | — |
| Medsol Clinical Research Center Inc | Port Charlotte | Florida | 33952 | — |
| Medsol Clinical Research Center Inc | Port Charlotte | Florida | 33980 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Pediatric Neurology PA | Winter Park | Florida | 32789 | — |
| Rare Disease Research, LLC | Atlanta | Georgia | 30318 | — |
| Rare Disease Research, LLC | Atlanta | Georgia | 30322 | — |
| Center for Rare Neurological Diseases | Norcross | Georgia | 30093 | — |
| Ann and Robert H Lurie Childrens Hospital of Chicago | Chicago | Illinois | 60611 | — |
| Bluegrass Epilepsy Research LLC | Lexington | Kentucky | 40504 | — |
| Boston Children's Hospital | Boston | Massachusetts | 02115 | — |
| Mayo Clinic - PIN | Rochester | Minnesota | 55905 | — |
| Minnesota Epilepsy Group PA | Saint Paul | Minnesota | 55102 | — |
| Max Benzaquen, M.D., PC | Chesterfield | Missouri | 63017 | — |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601-1974 | — |
| Children's Hospital at Saint Peter's University Hospital | New Brunswick | New Jersey | 08901 | — |
| NYU - Ambulatory Care Center (ACC) | New York | New York | 10016 | — |
| Columbia University Medical Center - PIN | New York | New York | 10032 | — |
| Wake Forest Baptist Medical Center - PPDS | Winston-Salem | North Carolina | 27157 | — |
| Medical University of South Carolina Childrens Hospital - PIN | Charleston | South Carolina | 29425 | — |
| Cook Children's Medical Center - Jane and John Justin Neurosciences Center | Fort Worth | Texas | 76104 | — |
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 32 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03635073, 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 Mar 18, 2026 · Synced May 19, 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 NCT03635073 live on ClinicalTrials.gov.