Cenobamate Open-Label Extension Study for YKP3089C025

Last updated: January 5, 2026
Sponsor: SK Life Science, Inc.
Overall Status: Active - Enrolling

Phase

3

Condition

Epilepsy

Seizure Disorders

Treatment

Cenobamate

Clinical Study ID

NCT03961568
YKP3089C033
  • Ages > 12
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subject must have successfully completed the Double-blind Treatment Period inthe Core study.

  • Written informed consent signed by the subject or legal guardian, prior to enteringthe study, in accordance with the International Council for Harmonisation (ICH) GoodClinical Practice (GCP) guidelines. If the written informed consent is provided bythe legal guardian because the subject is unable to do so, a written or verbalassent from the subject must also be obtained. As required by country-specificregulations, only the subject may sign the ICF in accordance with ICH guidelines.

Exclusion

Exclusion Criteria:

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

  • Any significant changes to the subject's medical history that, in the opinion of thePrincipal Investigator, could affect the subject's safety or conduct of the study.

Study Design

Total Participants: 145
Treatment Group(s): 1
Primary Treatment: Cenobamate
Phase: 3
Study Start date:
August 13, 2019
Estimated Completion Date:
August 31, 2026

Study 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

Connect with a study center

  • Multiprofile Hospital for Active Treatment Puls AD

    Blagoevgrad, 2700
    Bulgaria

    Site Not Available

  • Multiprofile Hospital for Active Treatment Puls AD

    Blagoevgrad 733191, 2700
    Bulgaria

    Site Not Available

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, 1407
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Neoclinic EAD

    Sofia, 1408
    Bulgaria

    Site Not Available

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia 727011, 1407
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Neoclinic EAD

    Sofia 727011, 1408
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Equita EOOD

    Varna, 9000
    Bulgaria

    Site Not Available

  • Diagnostic Consultative Center Equita EOOD

    Varna 726050, 9000
    Bulgaria

    Site Not Available

  • Medical Center Medica Plus OOD

    Veliko Tarnovo, 5000
    Bulgaria

    Site Not Available

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

    Veliko Tarnovo, 5100
    Bulgaria

    Site Not Available

  • Medical Center Medica Plus OOD

    Veliko Tarnovo 725993, 5000
    Bulgaria

    Site Not Available

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

    Veliko Tarnovo 725993, 5100
    Bulgaria

    Site Not Available

  • Cerebrovaskularni poradna

    Ostrava-Poruba, 708 52
    Czechia

    Site Not Available

  • Fakultni nemocnice v Motole

    Prague 3067696, 150 06
    Czechia

    Site Not Available

  • Forbeli s.r.o.-Neurologicka ambulance

    Prague 3067696, 160 00
    Czechia

    Site Not Available

  • Fakultni nemocnice v Motole

    Praha 5, 150 06
    Czechia

    Site Not Available

  • Forbeli s.r.o.-Neurologicka ambulance

    Praha 6, 160 00
    Czechia

    Site Not Available

  • Neurologicka ambulance

    Zlín, 760 01
    Czechia

    Site Not Available

  • Neurologicka ambulance

    Zlín 3061370, 760 01
    Czechia

    Site Not Available

  • Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika

    Budapest, 1083
    Hungary

    Site Not Available

  • Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika

    Budapest 3054643, 1083
    Hungary

    Site Not Available

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

    Poznan 3088171, Greater Poland Voivodeship 3337498 60-848
    Poland

    Site Not Available

  • Centrum Leczenia Padaczki i Migreny

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-209
    Poland

    Site Not Available

  • Centrum Leczenia Padaczki i Migreny

    Kraków, Malopolskie 31-209
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Warszawa

    Warsaw 756135, Masovian Voivodeship 858787 01-868
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Warszawa

    Warszawa, Mazowieckie 01-868
    Poland

    Site Not Available

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

    Katowice, Silesia 40-635
    Poland

    Site Not Available

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

    Katowice 3096472, Silesian Voivodeship 3337497 40-635
    Poland

    Site Not Available

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

    Poznań, Wielkopolskie 60-848
    Poland

    Site Not Available

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

    Banská Bystrica, 974 04
    Slovakia

    Site Not Available

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

    Banská Bystrica 3061186, 974 04
    Slovakia

    Site Not Available

  • IN MEDIC s.r.o.

    Bardejov, 085 01
    Slovakia

    Site Not Available

  • IN MEDIC s.r.o.

    Bardejov 725168, 085 01
    Slovakia

    Site Not Available

  • Konzilium, s.r.o.

    Dubnica Nad Váhom, 018 41
    Slovakia

    Site Not Available

  • Konzilium, s.r.o.

    Dubnica nad Váhom 3060346, 018 41
    Slovakia

    Site Not Available

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

    Dnepropetrovsk, Dnipropetrovsk 49027
    Ukraine

    Site Not Available

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

    Dnipro 709930, Dnipropetrovsk Oblast 709929 49027
    Ukraine

    Site Not Available

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

    Odesa 698740, Odesa Oblast 698738 65025
    Ukraine

    Site Not Available

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

    Odesa, Odessa 65025
    Ukraine

    Site Not Available

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

    Úzhgorod, Zakarpattia 88018
    Ukraine

    Site Not Available

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

    Uzhhorod 690548, Zakarpattia Oblast 687869 88018
    Ukraine

    Site Not Available

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporizhzhya 687700, Zaporizhzhya 69600
    Ukraine

    Site Not Available

  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council

    Zaporozhye, Zaporizhzhya 69600
    Ukraine

    Site Not Available

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

    Dnipro 709930, 49005
    Ukraine

    Site Not Available

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

    Dnipro 709930, 49005
    Ukraine

    Site Not Available

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

    Dnipropetrovs'k, 49005
    Ukraine

    Site Not Available

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

    Dnipropetrovs'k, 49005
    Ukraine

    Site Not Available

  • Regional Psyconeurology Hospital #3

    Ivano-Frankivs'k, 76011
    Ukraine

    Site Not Available

  • Regional Psyconeurology Hospital #3

    Ivano-Frankivsk 707471, 76011
    Ukraine

    Site Not Available

  • Communal Non-Commercial Enterprise of Kharkiv Regional Council

    Kharkiv, 61068
    Ukraine

    Site Not Available

  • Communal Non-Commercial Enterprise of Kharkiv Regional Council

    Kharkiv 706483, 61068
    Ukraine

    Site Not Available

  • Municipal Institution of Lviv Regional Council

    Lviv, 79010
    Ukraine

    Site Not Available

  • Municipal Institution of Lviv Regional Council

    Lviv 702550, 79010
    Ukraine

    Site Not Available

  • Ternopil Regional Municipal Psychoneurological Hospital

    Ternopil 691650, 46020
    Ukraine

    Site Not Available

  • Ternopil Regional Municipal Psychoneurological Hospital

    Ternopil', 46020
    Ukraine

    Site Not Available

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

    Vinnytsia 689558, 21005
    Ukraine

    Site Not Available

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

    Vinnytsya, 21005
    Ukraine

    Site Not Available

  • University of California, San Diego (UCSD)

    La Jolla, California 92093
    United States

    Site Not Available

  • University of California, San Diego (UCSD)

    La Jolla 5363943, California 5332921 92093
    United States

    Site Not Available

  • The Neurology Research Group, LLC.

    Miami, Florida 33176
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33606
    United States

    Site Not Available

  • The Neurology Research Group, LLC.

    Miami 4164138, Florida 4155751 33176
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 33606
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii 96814
    United States

    Site Not Available

  • Hawaii Pacific Neuroscience

    Honolulu 5856195, Hawaii 5855797 96814
    United States

    Site Not Available

  • Consultants in Epilepsy and Neurology, PLLC

    Boise, Idaho 83702
    United States

    Site Not Available

  • Consultants in Epilepsy and Neurology, PLLC

    Boise 5586437, Idaho 5596512 83702
    United States

    Site Not Available

  • Maine Medical Center

    Scarborough, Maine 04074
    United States

    Site Not Available

  • Maine Medical Center

    Scarborough 4977882, Maine 4971068 04074
    United States

    Site Not Available

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • Mid-Atlantic Epilepsy and Sleep Center

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology

    Golden Valley, Minnesota 55422
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester, Minnesota 01056
    United States

    Site Not Available

  • Minneapolis Clinic of Neurology

    Golden Valley 5028163, Minnesota 5037779 55422
    United States

    Site Not Available

  • Mayo Clinic - Rochester

    Rochester 5043473, Minnesota 5037779 01056
    United States

    Site Not Available

  • University of Missouri Medical School

    Columbia, Missouri 01074
    United States

    Site Not Available

  • University of Missouri Medical School

    Columbia 4381982, Missouri 4398678 01074
    United States

    Site Not Available

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Northeast Regional Epilepsy Group

    Hackensack 5098706, New Jersey 5101760 07601
    United States

    Site Not Available

  • Five Towns Neuroscience Research

    Woodmere, New York 11598
    United States

    Site Not Available

  • Five Towns Neuroscience Research

    Woodmere 5145028, New York 5128638 11598
    United States

    Site Not Available

  • Duke University

    Durham, North Carolina 27705
    United States

    Site Not Available

  • Duke University

    Durham 4464368, North Carolina 4482348 27705
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19140
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia 4560349, Pennsylvania 6254927 19140
    United States

    Site Not Available

  • Valley Medical Center

    Renton, Washington 98057
    United States

    Site Not Available

  • MultiCare Rockwood Neurology Center

    Spokane, Washington 99204
    United States

    Site Not Available

  • Valley Medical Center

    Renton 5808189, Washington 5815135 98057
    United States

    Site Not Available

  • MultiCare Rockwood Neurology Center

    Spokane 5811696, Washington 5815135 99204
    United States

    Site Not Available

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