Cenobamate Open-Label Extension Study for YKP3089C025

Completed · Phase 3 · Has a placebo group

Conditions studied: Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy

In brief

52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)

Key facts

Study ID

NCT03961568

Run by

SK Life Science, Inc.

People needed

147

Starts

2019-08-13

Expected to finish

2026-06-10

Last updated by the study team

2026-06-26

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Subject tests positive, via urine drug screen at Visit 14 of the Core study, for illicit drugs except for tetrahydrocannabinol and Cannabinoids.
• 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.

Where it is running

• University of California, San Diego (UCSD) — La Jolla, California, United States
• The Neurology Research Group, LLC. — Miami, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Hawaii Pacific Neuroscience — Honolulu, Hawaii, United States
• Consultants in Epilepsy and Neurology, PLLC — Boise, Idaho, United States
• Maine Medical Center — Scarborough, Maine, United States
• Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
• Minneapolis Clinic of Neurology — Golden Valley, Minnesota, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• University of Missouri Medical School — Columbia, Missouri, United States
• Northeast Regional Epilepsy Group — Hackensack, New Jersey, United States
• Five Towns Neuroscience Research — Woodmere, New York, United States
• Duke University — Durham, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Valley Medical Center — Renton, Washington, United States
• MultiCare Rockwood Neurology Center — Spokane, Washington, United States
• Multiprofile Hospital for Active Treatment Puls AD — Blagoevgrad, Blagoevgrad, Bulgaria
• Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD — Sofia, Sofia, Bulgaria
• Diagnostic Consultative Center Neoclinic EAD — Sofia, Sofia, Bulgaria
• Diagnostic Consultative Center Equita EOOD — Varna, Varna, Bulgaria
• Medical Center Medica Plus OOD — Veliko Tarnovo, Veliko Tarnovo, Bulgaria
• Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD — Veliko Tarnovo, Veliko Tarnovo, Bulgaria
• Cerebrovaskularni poradna — Ostrava-Poruba, Czechia
• Fakultni nemocnice v Motole — Prague, Czechia
• Forbeli s.r.o.-Neurologicka ambulance — Prague, Czechia

Full record on ClinicalTrials.gov

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