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52 Week Open-Label Safety Study of Cenobamate for Subjects who Complete YKP3089C025 (core study)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Core Study Placebo | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cenobamate | Drug | active drug |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sunita Misra, MD | SK Life Science, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego (UCSD) | La Jolla | California | 92093 | United States | ||
| The Neurology Research Group, LLC. |
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| Miami |
| Florida |
| 33176 |
| United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Hawaii Pacific Neuroscience | Honolulu | Hawaii | 96814 | United States |
| Consultants in Epilepsy and Neurology, PLLC | Boise | Idaho | 83702 | United States |
| Maine Medical Center | Scarborough | Maine | 04074 | United States |
| Mid-Atlantic Epilepsy and Sleep Center | Bethesda | Maryland | 20817 | United States |
| Minneapolis Clinic of Neurology | Golden Valley | Minnesota | 55422 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 01056 | United States |
| University of Missouri Medical School | Columbia | Missouri | 01074 | United States |
| Northeast Regional Epilepsy Group | Hackensack | New Jersey | 07601 | United States |
| Five Towns Neuroscience Research | Woodmere | New York | 11598 | United States |
| Duke University | Durham | North Carolina | 27705 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19140 | United States |
| Valley Medical Center | Renton | Washington | 98057 | United States |
| MultiCare Rockwood Neurology Center | Spokane | Washington | 99204 | United States |
| Multiprofile Hospital for Active Treatment Puls AD | Blagoevgrad | Blagoevgrad | 2700 | Bulgaria |
| Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD | Sofia | Sofia | 1407 | Bulgaria |
| Diagnostic Consultative Center Neoclinic EAD | Sofia | Sofia | 1408 | Bulgaria |
| Diagnostic Consultative Center Equita EOOD | Varna | Varna | 9000 | Bulgaria |
| Medical Center Medica Plus OOD | Veliko Tarnovo | Veliko Tarnovo | 5000 | Bulgaria |
| Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD | Veliko Tarnovo | Veliko Tarnovo | 5100 | Bulgaria |
| Cerebrovaskularni poradna | Ostrava-Poruba | 708 52 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| Forbeli s.r.o.-Neurologicka ambulance | Prague | 160 00 | Czechia |
| Neurologicka ambulance | Zlín | 760 01 | Czechia |
| Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika | Budapest | 1083 | Hungary |
| Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k. | Poznan | Greater Poland Voivodeship | 60-848 | Poland |
| Centrum Leczenia Padaczki i Migreny | Krakow | Lesser Poland Voivodeship | 31-209 | Poland |
| Centrum Medyczne Pratia Warszawa | Warsaw | Masovian Voivodeship | 01-868 | Poland |
| Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach | Katowice | Silesian Voivodeship | 40-635 | Poland |
| MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o. | Banská Bystrica | 974 04 | Slovakia |
| IN MEDIC s.r.o. | Bardejov | 085 01 | Slovakia |
| Konzilium, s.r.o. | Dubnica nad Váhom | 018 41 | Slovakia |
| Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council | Dnipro | Dnipropetrovsk Oblast | 49027 | Ukraine |
| Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases | Odesa | Odesa Oblast | 65025 | Ukraine |
| Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University" | Uzhhorod | Zakarpattia Oblast | 88018 | Ukraine |
| Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council | Zaporizhzhya | Zaporizhzhya | 69600 | Ukraine |
| Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center | Dnipro | 49005 | Ukraine |
| Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov" | Dnipro | 49005 | Ukraine |
| Regional Psyconeurology Hospital #3 | Ivano-Frankivsk | 76011 | Ukraine |
| Communal Non-Commercial Enterprise of Kharkiv Regional Council | Kharkiv | 61068 | Ukraine |
| Municipal Institution of Lviv Regional Council | Lviv | 79010 | Ukraine |
| Ternopil Regional Municipal Psychoneurological Hospital | Ternopil | 46020 | Ukraine |
| Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch | Vinnytsia | 21005 | Ukraine |
| ID | Term |
|---|---|
| C562694 | Epilepsy, Idiopathic Generalized |
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| ID | Term |
|---|---|
| C000654784 | Cenobamate |
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