Cenobamate Open-Label Extension Study for YKP3089C025

NCT ID: NCT03961568

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE3
• Total Enrollment: 145 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-13
• Study Completion Date: 2026-08-31

Brief Summary

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

Detailed Description

52 Week Open-Label Safety Study of cenobamate adjunctive therapy for subjects who complete double-blind study YKP3089C025. Subjects will have a 12 week double-blind conversion phase where subjects who received placebo in the double-blind study will be converted to cenobamate. Subjects who received cenobamate in the double-blind study will continue to receive their daily dose of cenobamate. Subjects switching from placebo to cenobamate will be titrated starting at 12.5 mg and increase their dose over the course of 12 weeks as follows 12.5 mg for 2 weeks, 25 mg for two weeks, 50 mg for two weeks, 100 mg for two weeks, 150 mg for two weeks, and 200 mg for two weeks. All subjects will receive 200 mg for the last two weeks of the conversion phase to preserve the blind. After completing the double-blind conversion phase, subjects will have 40 weeks of open-label, flexibly dosed cenobamate. The dose range is 50 mg - 200 mg. Primary endpoints are all safety measures.

Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Core Study Placebo

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.

Group Type: EXPERIMENTAL

Cenobamate

Intervention Type: DRUG

active drug

Core Study Active

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.

Group Type: EXPERIMENTAL

Cenobamate

Intervention Type: DRUG

active drug

Interventions

Cenobamate

active drug

Intervention Type: DRUG

Other Intervention Names

YKP3089

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SK Life Science, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sunita Misra, MD

Role: STUDY_DIRECTOR

SK Life Science, Inc.

Locations

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, , Bulgaria

Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

Sofia, , Bulgaria

Diagnostic Consultative Center Neoclinic EAD

Sofia, , Bulgaria

Diagnostic Consultative Center Equita EOOD

Varna, , Bulgaria

Medical Center Medica Plus OOD

Veliko Tarnovo, , Bulgaria

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

Veliko Tarnovo, , Bulgaria

Cerebrovaskularni poradna

Ostrava-Poruba, , Czechia

Fakultni nemocnice v Motole

Prague, , Czechia

Forbeli s.r.o.-Neurologicka ambulance

Prague, , Czechia

Neurologicka ambulance

Zlín, , Czechia

Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika

Budapest, , Hungary

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

Poznan, Greater Poland Voivodeship, Poland

Centrum Leczenia Padaczki i Migreny

Krakow, Lesser Poland Voivodeship, Poland

Centrum Medyczne Pratia Warszawa

Warsaw, Masovian Voivodeship, Poland

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

Katowice, Silesian Voivodeship, Poland

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

Banská Bystrica, , Slovakia

IN MEDIC s.r.o.

Bardejov, , Slovakia

Konzilium, s.r.o.

Dubnica nad Váhom, , Slovakia

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

Dnipro, Dnipropetrovsk Oblast, Ukraine

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

Odesa, Odesa Oblast, Ukraine

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

Uzhhorod, Zakarpattia Oblast, Ukraine

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

Zaporizhzhya, Zaporizhzhya, Ukraine

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

Dnipro, , Ukraine

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

Dnipro, , Ukraine

Regional Psyconeurology Hospital #3

Ivano-Frankivsk, , Ukraine

Communal Non-Commercial Enterprise of Kharkiv Regional Council

Kharkiv, , Ukraine

Municipal Institution of Lviv Regional Council

Lviv, , Ukraine

Ternopil Regional Municipal Psychoneurological Hospital

Ternopil, , Ukraine

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

Vinnytsia, , Ukraine

Countries

United States; Bulgaria; Czechia; Hungary; Poland; Slovakia; Ukraine

Other Identifiers

YKP3089C033

Identifier Type: -

Identifier Source: org_study_id