Cenobamate Open-Label Extension Study for YKP3089C025

Phase 3

• Conditions: Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
• Interventions: Drug: Cenobamate

• Registration Number: NCT03961568
• Lead Sponsor: SK Life Science, Inc.

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

Study Timeline

• Study First Submitted: 2019-05-21
• Study First Submitted QC: 2019-05-21
• Study First Posted: 2019-05-23
• Study Start: 2019-08-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-13
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 145

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Core Study Placebo	Cenobamate	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.
Core Study Active	Cenobamate	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events and SAEs	386 +/- 2 days	Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.

Trial Locations

Locations (45)

Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council; 🇺🇦 Zaporozhye, Zaporizhzhya, Ukraine

Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center; 🇺🇦 Dnipropetrovs'k, Ukraine

Regional Psyconeurology Hospital #3; 🇺🇦 Ivano-Frankivs'k, Ukraine

Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"; 🇺🇦 Dnipropetrovs'k, 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; 🇺🇦 Vinnytsya, Ukraine

Mayo Clinic - Rochester; 🇺🇸 Rochester, Minnesota, United States

University of Missouri Medical School; 🇺🇸 Columbia, Missouri, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

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

Northeast Regional Epilepsy Group; 🇺🇸 Hackensack, New Jersey, United States

Five Towns Neuroscience Research; 🇺🇸 Woodmere, New York, 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; 🇨🇿 Praha 5, Czechia

Forbeli s.r.o.-Neurologicka ambulance; 🇨🇿 Praha 6, Czechia

Neurologicka ambulance; 🇨🇿 Zlín, Czechia

Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika; 🇭🇺 Budapest, Hungary

Centrum Leczenia Padaczki i Migreny; 🇵🇱 Kraków, Malopolskie, Poland

Centrum Medyczne Pratia Warszawa; 🇵🇱 Warszawa, Mazowieckie, Poland

Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach; 🇵🇱 Katowice, Silesia, Poland

Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.; 🇵🇱 Poznań, Wielkopolskie, 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; 🇺🇦 Dnepropetrovsk, Dnipropetrovsk, Ukraine

Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases; 🇺🇦 Odesa, Odessa, Ukraine

Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"; 🇺🇦 Úzhgorod, Zakarpattia, Ukraine