Cenobamate Open-Label Extension Study for YKP3089C025
Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
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
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
Experimental
Experimental
Core Study Placebo
Core Study Active
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.