NCT03961568CompletedPhase 3
Cenobamate Open-Label Extension Study for YKP3089C025
A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 147 (actual)
- First submitted
- 21 May 2019
- Start date
- 13 Aug 2019
- Primary completion date
- 10 Jun 2026
- Lead sponsor
- SK Life Science, Inc.
- Diseases
- Epilepsy
- NCT number
- NCT03961568
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 147
- From 13 Aug 2019 to the primary completion date, 10 Jun 2026
- 45 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.
Other
- Any significant changes to the subject's medical history that, in the opinion of the Principal Investigator, could affect the subject's safety or conduct of the study.
Who the study is looking for
- The subject must have successfully completed the Double-blind Treatment Period in the Core study.
- Written informed consent signed by the subject or legal guardian, prior to entering the study, in accordance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) guidelines. If the written informed consent is provided by the legal guardian because the subject is unable to do so, a written or verbal assent from the subject must also be obtained. As required by country-specific regulations, only the subject may sign the ICF in accordance with ICH guidelines.
Age in the registry: 12 years to - · Sex: All · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiprofile hospital for active treatment Puls AD Coordinator of this site? Confirm its status | Blagoevgrad | Bulgaria | Unknown status |
| Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Diagnostic Consultative Center Neoclinic EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Unknown status |
| Diagnostic Consultative Center Equita EOOD Coordinator of this site? Confirm its status | Varna | Bulgaria | Unknown status |
| Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD Coordinator of this site? Confirm its status | Veliko Tarnovo | Bulgaria | Unknown status |
| Medical Center Medica Plus OOD Coordinator of this site? Confirm its status | Veliko Tarnovo | Bulgaria | Unknown status |
| Cerebrovaskularni poradna Coordinator of this site? Confirm its status | Ostrava-Poruba | Czechia | Unknown status |
| Fakultni nemocnice v Motole Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Forbeli s.r.o.-Neurologicka ambulance Coordinator of this site? Confirm its status | Prague | Czechia | Unknown status |
| Neurologicka ambulance Coordinator of this site? Confirm its status | Zlín | Czechia | Unknown status |
| Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika Coordinator of this site? Confirm its status | Budapest | Hungary | Unknown status |
| Gornoslaskie Centrum Medyczne Im Prof. Leszka Gieca Sląskiego Uniwersytetu Medycznego W Katowicach Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Centrum Leczenia Padaczki i Migreny Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k. Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Centrum Medyczne Pratia Warszawa Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| MUDr. Beata Dupejova, Neurologicka Ambulancia S.r.o. Coordinator of this site? Confirm its status | Banská Bystrica | Slovakia | Unknown status |
| IN MEDIC, s.r.o. Coordinator of this site? Confirm its status | Bardejov | Slovakia | Unknown status |
| KONZILIUM s.r.o Coordinator of this site? Confirm its status | Dubnica nad Váhom | Slovakia | Unknown status |
| Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov" Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Regional Psyconeurology Hospital #3 Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Unknown status |
| Communal Non-Commercial Enterprise of Kharkiv Regional Council Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Municipal Institution of Lviv Regional Council Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases Coordinator of this site? Confirm its status | Odesa | Ukraine | Unknown status |
| Ternopil Regional Municipal Psychoneurological Hospital Coordinator of this site? Confirm its status | Ternopil | Ukraine | Unknown status |
| Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University" Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Unknown status |
| Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Unknown status |
| Mid-Atlantic Epilepsy and Sleep Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| Consultants in Epilepsy and Neurology PLLC Coordinator of this site? Confirm its status | Boise | United States | Unknown status |
| University of Missouri Medical School Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| Duke University Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Minneapolis Clinic of Neurology Coordinator of this site? Confirm its status | Golden Valley | United States | Unknown status |
| Northeast Regional Epilepsy Group Coordinator of this site? Confirm its status | Hackensack | United States | Unknown status |
| Hawaii Pacific Neuroscience Coordinator of this site? Confirm its status | Honolulu | United States | Unknown status |
| University of California San Diego (UCSD) Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| The Neurology Research Group, LLC Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| University of Pennsylvania Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Valley Medical Center Coordinator of this site? Confirm its status | Renton | United States | Unknown status |
| Mayo Clinic - Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Maine Medical Center Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| MultiCare Rockwood Neurology Center Coordinator of this site? Confirm its status | Spokane | United States | Unknown status |
| University of South Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Five Towns Neuroscience Research Coordinator of this site? Confirm its status | Woodmere | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.