Cenobamate Open-Label Extension Study for YKP3089C025

NCT03961568 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: YKP3089C033
• Study Type: interventional
• Target: 145
• Locations: 7 countries
• Sites: 45

Brief Summary

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

Conditions

Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy

Keywords

Idiopathic Generalized Epilepsy

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events and SAEs

  Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.

  386 +/- 2 days

Study Arms (2)

Core Study Placebo

EXPERIMENTAL

Subjects who did not receive Cenobamate in the Core Study will receive Cenobamate 12.5 mg tablet once a day for two weeks, 25 mg tablet once a day for two weeks, 50 mg tablet once a day for two weeks, 100 mg tablets once a day for two weeks, 150 mg tablets once a day for two weeks and 200 mg tablets once a day for twelve weeks. Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.

Drug: Cenobamate

Core Study Active

EXPERIMENTAL

Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg). Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight.

Drug: Cenobamate

Interventions

Cenobamate DRUG

active drug

Also known as: YKP3089

Core Study Active; Core Study Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• SK Life Science, Inc.: lead

Study Sites (45)

University of California, San Diego (UCSD)

La Jolla, California, 92093, United States

Location

The Neurology Research Group, LLC.

Miami, Florida, 33176, United States

Location

University of South Florida

Tampa, Florida, 33606, United States

Location

Hawaii Pacific Neuroscience

Honolulu, Hawaii, 96814, United States

Location

Consultants in Epilepsy and Neurology, PLLC

Boise, Idaho, 83702, United States

Location

Maine Medical Center

Scarborough, Maine, 04074, United States

Location

Mid-Atlantic Epilepsy and Sleep Center

Bethesda, Maryland, 20817, United States

Location

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, 55422, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 01056, United States

Location

University of Missouri Medical School

Columbia, Missouri, 01074, United States

Location

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

Location

Five Towns Neuroscience Research

Woodmere, New York, 11598, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19140, United States

Location

Valley Medical Center

Renton, Washington, 98057, United States

Location

MultiCare Rockwood Neurology Center

Spokane, Washington, 99204, United States

Location

Multiprofile Hospital for Active Treatment Puls AD

Blagoevgrad, 2700, Bulgaria

Location

Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, 1407, Bulgaria

Location

Diagnostic Consultative Center Neoclinic EAD

Sofia, 1408, Bulgaria

Location

Diagnostic Consultative Center Equita EOOD

Varna, 9000, Bulgaria

Location

Medical Center Medica Plus OOD

Veliko Tarnovo, 5000, Bulgaria

Location

Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD

Veliko Tarnovo, 5100, Bulgaria

Location

Cerebrovaskularni poradna

Ostrava-Poruba, 708 52, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Forbeli s.r.o.-Neurologicka ambulance

Prague, 160 00, Czechia

Location

Neurologicka ambulance

Zlín, 760 01, Czechia

Location

Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika

Budapest, 1083, Hungary

Location

Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.

Poznan, Greater Poland Voivodeship, 60-848, Poland

Location

Centrum Leczenia Padaczki i Migreny

Krakow, Lesser Poland Voivodeship, 31-209, Poland

Location

Centrum Medyczne Pratia Warszawa

Warsaw, Masovian Voivodeship, 01-868, Poland

Location

Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

Katowice, Silesian Voivodeship, 40-635, Poland

Location

MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.

Banská Bystrica, 974 04, Slovakia

Location

IN MEDIC s.r.o.

Bardejov, 085 01, Slovakia

Location

Konzilium, s.r.o.

Dubnica nad Váhom, 018 41, Slovakia

Location

Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council

Dnipro, Dnipropetrovsk Oblast, 49027, Ukraine

Location

Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases

Odesa, Odesa Oblast, 65025, Ukraine

Location

Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"

Uzhhorod, Zakarpattia Oblast, 88018, Ukraine

Location

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporizhzhya, Zaporizhzhya, 69600, Ukraine

Location

Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center

Dnipro, 49005, Ukraine

Location

Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"

Dnipro, 49005, Ukraine

Location

Regional Psyconeurology Hospital #3

Ivano-Frankivsk, 76011, Ukraine

Location

Communal Non-Commercial Enterprise of Kharkiv Regional Council

Kharkiv, 61068, Ukraine

Location

Municipal Institution of Lviv Regional Council

Lviv, 79010, Ukraine

Location

Ternopil Regional Municipal Psychoneurological Hospital

Ternopil, 46020, Ukraine

Location

Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch

Vinnytsia, 21005, Ukraine

Location

MeSH Terms

Conditions

Epilepsy, Idiopathic Generalized

Interventions

Cenobamate

Study Officials

• Sunita Misra, MD

  SK Life Science, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: May 23, 2019
• Study Start: August 13, 2019
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Locations

HU (1); US (16); PL (4); SL (3); UA (11); CZ (4); BU (6)