Cenobamate Open-Label Extension Study for YKP3089C025

A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
• Intervention / Treatment: Drug: Cenobamate

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 Type: Interventional
• Enrollment (Estimated): 145
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Blagoevgrad, Bulgaria, 2700
    • Multiprofile Hospital for Active Treatment Puls AD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
  • Sofia, Bulgaria, 1408
    • Diagnostic Consultative Center Neoclinic EAD
  • Varna, Bulgaria, 9000
    • Diagnostic Consultative Center Equita EOOD
  • Veliko Tarnovo, Bulgaria, 5000
    • Medical Center Medica Plus OOD
  • Veliko Tarnovo, Bulgaria, 5100
    • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD
• Czechia
  • Ostrava-Poruba, Czechia, 708 52
    • Cerebrovaskularni poradna
  • Praha 5, Czechia, 150 06
    • Fakultni nemocnice v Motole
  • Praha 6, Czechia, 160 00
    • Forbeli s.r.o.-Neurologicka ambulance
  • Zlín, Czechia, 760 01
    • Neurologicka ambulance
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika
• Poland
  • Malopolskie
    • Kraków, Malopolskie, Poland, 31-209
      • Centrum Leczenia Padaczki i Migreny
  • Mazowieckie
    • Warszawa, Mazowieckie, Poland, 01-868
      • Centrum Medyczne Pratia Warszawa
  • Silesia
    • Katowice, Silesia, Poland, 40-635
      • Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
  • Wielkopolskie
    • Poznań, Wielkopolskie, Poland, 60-848
      • Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.
• Slovakia
  • Banská Bystrica, Slovakia, 974 04
    • MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.
  • Bardejov, Slovakia, 085 01
    • IN MEDIC s.r.o.
  • Dubnica Nad Váhom, Slovakia, 018 41
    • Konzilium, s.r.o.
• Ukraine
  • Dnipropetrovs'k, Ukraine, 49005
    • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center
  • Dnipropetrovs'k, Ukraine, 49005
    • Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"
  • Ivano-Frankivs'k, Ukraine, 76011
    • Regional Psyconeurology Hospital #3
  • Kharkiv, Ukraine, 61068
    • Communal Non-Commercial Enterprise of Kharkiv Regional Council
  • Lviv, Ukraine, 79010
    • Municipal Institution of Lviv Regional Council
  • Ternopil', Ukraine, 46020
    • Ternopil Regional Municipal Psychoneurological Hospital
  • Vinnytsya, Ukraine, 21005
    • Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch
  • Dnipropetrovsk
    • Dnepropetrovsk, Dnipropetrovsk, Ukraine, 49027
      • Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council
  • Odessa
    • Odesa, Odessa, Ukraine, 65025
      • Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases
  • Zakarpattia
    • Úzhgorod, Zakarpattia, Ukraine, 88018
      • Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"
  • Zaporizhzhya
    • Zaporozhye, Zaporizhzhya, Ukraine, 69600
      • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego (UCSD)
  • Florida
    • Miami, Florida, United States, 33176
      • The Neurology Research Group, LLC.
    • Tampa, Florida, United States, 33606
      • University of South Florida
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • Hawaii Pacific Neuroscience
  • Idaho
    • Boise, Idaho, United States, 83702
      • Consultants in Epilepsy and Neurology, PLLC
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Medical Center
  • Maryland
    • Bethesda, Maryland, United States, 20817
      • Mid-Atlantic Epilepsy and Sleep Center
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Northeast Regional Epilepsy Group
  • New York
    • Woodmere, New York, United States, 11598
      • Five Towns Neuroscience Research
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19140
      • University of Pennsylvania
  • Washington
    • Renton, Washington, United States, 98057
      • Valley Medical Center
    • Spokane, Washington, United States, 99204
      • MultiCare Rockwood Neurology Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Cenobamate; active drug; Other Names: YKP3089
Experimental: 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.	Drug: Cenobamate; active drug; Other Names: YKP3089

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SK Life Science, Inc.
• Investigators: Study Director: Sunita Misra, MD, SK Life Science, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Estimated): May 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: May 21, 2019
• First Posted (Actual): May 23, 2019

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Idiopathic Generalized Epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Epilepsy, Generalized; Anticonvulsants; Cenobamate
• Other Study ID Numbers: YKP3089C033

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No