Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy Clinical Trial
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
| Verified date | February 2024 |
| Source | SK Life Science, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
| Status | Enrolling by invitation |
| Enrollment | 145 |
| Est. completion date | November 2025 |
| Est. primary completion date | May 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | 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 | |
| Czechia | Cerebrovaskularni poradna | Ostrava-Poruba | |
| Czechia | Fakultni nemocnice v Motole | Praha 5 | |
| Czechia | Forbeli s.r.o.-Neurologicka ambulance | Praha 6 | |
| Czechia | Neurologicka ambulance | Zlín | |
| Hungary | Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika | Budapest | |
| Poland | Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | Silesia |
| Poland | Centrum Leczenia Padaczki i Migreny | Kraków | Malopolskie |
| Poland | Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k. | Poznan | Wielkopolskie |
| Poland | Centrum Medyczne Pratia Warszawa | Warszawa | Mazowieckie |
| Slovakia | 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 | |
| Ukraine | Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council | Dnepropetrovsk | Dnipropetrovsk |
| Ukraine | Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center | Dnipropetrovs'k | |
| Ukraine | Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov" | Dnipropetrovs'k | |
| Ukraine | Regional Psyconeurology Hospital #3 | Ivano-Frankivs'k | |
| Ukraine | Communal Non-Commercial Enterprise of Kharkiv Regional Council | Kharkiv | |
| Ukraine | Municipal Institution of Lviv Regional Council | Lviv | |
| Ukraine | Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases | Odesa | Odessa |
| Ukraine | Ternopil Regional Municipal Psychoneurological Hospital | Ternopil' | |
| Ukraine | Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University" | Úzhgorod | Zakarpattia |
| Ukraine | Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch | Vinnytsya | |
| Ukraine | Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council | Zaporozhye | Zaporizhzhya |
| United States | Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland |
| United States | Consultants in Epilepsy and Neurology, PLLC | Boise | Idaho |
| United States | Minneapolis Clinic of Neurology | Golden Valley | Minnesota |
| United States | Northeast Regional Epilepsy Group | Hackensack | New Jersey |
| United States | Hawaii Pacific Neuroscience | Honolulu | Hawaii |
| United States | University of California, San Diego (UCSD) | La Jolla | California |
| United States | The Neurology Research Group, LLC. | Miami | Florida |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Valley Medical Center | Renton | Washington |
| United States | Maine Medical Center | Scarborough | Maine |
| United States | MultiCare Rockwood Neurology Center | Spokane | Washington |
| United States | University of South Florida | Tampa | Florida |
| United States | Five Towns Neuroscience Research | Woodmere | New York |
| Lead Sponsor | Collaborator |
|---|---|
| SK Life Science, Inc. |
United States, Bulgaria, Czechia, Hungary, Poland, Slovakia, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 |