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Cenobamate Open-Label Extension Study for YKP3089C025

Primary Purpose

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

Status
Enrolling by invitation
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Cenobamate
Sponsored by
SK Life Science, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy focused on measuring Idiopathic Generalized Epilepsy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, San Diego (UCSD)
  • The Neurology Research Group, LLC.
  • University of South Florida
  • Hawaii Pacific Neuroscience
  • Consultants in Epilepsy and Neurology, PLLC
  • Maine Medical Center
  • Mid-Atlantic Epilepsy and Sleep Center
  • Minneapolis Clinic of Neurology
  • Northeast Regional Epilepsy Group
  • Five Towns Neuroscience Research
  • University of Pennsylvania
  • Valley Medical Center
  • MultiCare Rockwood Neurology Center
  • Multiprofile Hospital for Active Treatment Puls AD
  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
  • Diagnostic Consultative Center Neoclinic EAD
  • Diagnostic Consultative Center Equita EOOD
  • Medical Center Medica Plus OOD
  • Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD
  • Cerebrovaskularni poradna
  • Fakultni nemocnice v Motole
  • Forbeli s.r.o.-Neurologicka ambulance
  • Neurologicka ambulance
  • Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika
  • Centrum Leczenia Padaczki i Migreny
  • Centrum Medyczne Pratia Warszawa
  • Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
  • Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.
  • MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.
  • IN MEDIC s.r.o.
  • Konzilium, s.r.o.
  • Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council
  • Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases
  • Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"
  • Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
  • Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center
  • Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"
  • Regional Psyconeurology Hospital #3
  • Communal Non-Commercial Enterprise of Kharkiv Regional Council
  • Municipal Institution of Lviv Regional Council
  • Ternopil Regional Municipal Psychoneurological Hospital
  • Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Core Study Placebo

Core Study Active

Arm Description

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. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.

Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg). The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 21, 2019
Last Updated
May 24, 2023
Sponsor
SK Life Science, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03961568
Brief Title
Cenobamate Open-Label Extension Study for YKP3089C025
Official Title
A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 13, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SK Life Science, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
Keywords
Idiopathic Generalized Epilepsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Core Study Placebo
Arm Type
Experimental
Arm Description
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. The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.
Arm Title
Core Study Active
Arm Type
Experimental
Arm Description
Subjects who received cenobamate in the Core study will continue to receive the same daily dose (150 mg or 200mg). The adolescent subjects will follow the same regimen in an oral suspension adolescent equivalent dose based on weight.
Intervention Type
Drug
Intervention Name(s)
Cenobamate
Other Intervention Name(s)
YKP3089
Intervention Description
active drug
Primary Outcome Measure Information:
Title
Incidence of Adverse Events and SAEs
Description
Summary statistics for clinical laboratory test results and vital signs; and physical examination, neurologic examination and electrocardiogram (ECG) finding.
Time Frame
386 +/- 2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Kamin, MD
Organizational Affiliation
SK Life Science, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego (UCSD)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
The Neurology Research Group, LLC.
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Hawaii Pacific Neuroscience
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Consultants in Epilepsy and Neurology, PLLC
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Maine Medical Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Northeast Regional Epilepsy Group
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Five Towns Neuroscience Research
City
Woodmere
State/Province
New York
ZIP/Postal Code
11598
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Valley Medical Center
City
Renton
State/Province
Washington
ZIP/Postal Code
98057
Country
United States
Facility Name
MultiCare Rockwood Neurology Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Multiprofile Hospital for Active Treatment Puls AD
City
Blagoevgrad
ZIP/Postal Code
2700
Country
Bulgaria
Facility Name
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Diagnostic Consultative Center Neoclinic EAD
City
Sofia
ZIP/Postal Code
1408
Country
Bulgaria
Facility Name
Diagnostic Consultative Center Equita EOOD
City
Varna
ZIP/Postal Code
9000
Country
Bulgaria
Facility Name
Medical Center Medica Plus OOD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD
City
Veliko Tarnovo
ZIP/Postal Code
5100
Country
Bulgaria
Facility Name
Cerebrovaskularni poradna
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Forbeli s.r.o.-Neurologicka ambulance
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
Neurologicka ambulance
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Centrum Leczenia Padaczki i Migreny
City
Kraków
State/Province
Malopolskie
ZIP/Postal Code
31-209
Country
Poland
Facility Name
Centrum Medyczne Pratia Warszawa
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-868
Country
Poland
Facility Name
Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
City
Katowice
State/Province
Silesia
ZIP/Postal Code
40-635
Country
Poland
Facility Name
Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.
City
Poznań
State/Province
Wielkopolskie
ZIP/Postal Code
60-848
Country
Poland
Facility Name
MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.
City
Banská Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Facility Name
IN MEDIC s.r.o.
City
Bardejov
ZIP/Postal Code
085 01
Country
Slovakia
Facility Name
Konzilium, s.r.o.
City
Dubnica Nad Váhom
ZIP/Postal Code
018 41
Country
Slovakia
Facility Name
Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council
City
Dnepropetrovsk
State/Province
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases
City
Odesa
State/Province
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"
City
Úzhgorod
State/Province
Zakarpattia
ZIP/Postal Code
88018
Country
Ukraine
Facility Name
Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
City
Zaporozhye
State/Province
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center
City
Dnipropetrovs'k
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"
City
Dnipropetrovs'k
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Regional Psyconeurology Hospital #3
City
Ivano-Frankivs'k
ZIP/Postal Code
76011
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise of Kharkiv Regional Council
City
Kharkiv
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Municipal Institution of Lviv Regional Council
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Ternopil Regional Municipal Psychoneurological Hospital
City
Ternopil'
ZIP/Postal Code
46020
Country
Ukraine
Facility Name
Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch
City
Vinnytsya
ZIP/Postal Code
21005
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

Cenobamate Open-Label Extension Study for YKP3089C025

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