Clinical trial NCT03961568: 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
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy
Keywords: Idiopathic Generalized Epilepsy
Lead sponsor: SK Life Science, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-23
Enrollment: 145
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Adolescents will follow the same every two week regimen and receive cenobamate as an oral suspension based on weight

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.

Primary outcomes:
measure: Incidence of Adverse Events and SAEs
timeFrame: 386 +/- 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego (UCSD)
state: California
city: Miami
country: United States
facility: The Neurology Research Group, LLC.
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Boise
country: United States
facility: Consultants in Epilepsy and Neurology, PLLC
state: Idaho
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Bethesda
country: United States
facility: Mid-Atlantic Epilepsy and Sleep Center
state: Maryland
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Medical School
state: Missouri
city: Hackensack
country: United States
facility: Northeast Regional Epilepsy Group
state: New Jersey
city: Woodmere
country: United States
facility: Five Towns Neuroscience Research
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Renton
country: United States
facility: Valley Medical Center
state: Washington
city: Spokane
country: United States
facility: MultiCare Rockwood Neurology Center
state: Washington
city: Blagoevgrad
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Puls AD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
city: Sofia
country: Bulgaria
facility: Diagnostic Consultative Center Neoclinic EAD
city: Varna
country: Bulgaria
facility: Diagnostic Consultative Center Equita EOOD
city: Veliko Tarnovo
country: Bulgaria
facility: Medical Center Medica Plus OOD
city: Veliko Tarnovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Sv. Ivan Rilski Gorna Oryahovitsa EOOD
city: Ostrava-Poruba
country: Czechia
facility: Cerebrovaskularni poradna
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Praha 6
country: Czechia
facility: Forbeli s.r.o.-Neurologicka ambulance
city: Zlín
country: Czechia
facility: Neurologicka ambulance
city: Budapest
country: Hungary
facility: Semmelweis Egyetem I. Sz. Gyermekgyogyaszati Klinika
city: Kraków
country: Poland
facility: Centrum Leczenia Padaczki i Migreny
state: Malopolskie
city: Warszawa
country: Poland
facility: Centrum Medyczne Pratia Warszawa
state: Mazowieckie
city: Katowice
country: Poland
facility: Górnoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach
state: Silesia
city: Poznań
country: Poland
facility: Clinical Research Center Spólka z Ograniczona Odpowiedzialnoscia Medic-R sp. k.
state: Wielkopolskie
city: Banská Bystrica
country: Slovakia
facility: MUDr. Beata Dupejova, neurologicka ambulancia, s.r.o.
city: Bardejov
country: Slovakia
facility: IN MEDIC s.r.o.
city: Dubnica Nad Váhom
country: Slovakia
facility: Konzilium, s.r.o.
city: Dnepropetrovsk
country: Ukraine
facility: Municipal Institution "Dnipropetrovsk City Clinical Hospital No16" of Dnipropetrovsk Regional Council
state: Dnipropetrovsk
city: Odesa
country: Ukraine
facility: Municipal Institution Odesa Regional Clinical Hospital, Department of Cerebro-Vascular Diseases
state: Odessa
city: Úzhgorod
country: Ukraine
facility: Regional Clinical Center of Neurosurgery and Neurology "Uzhhorod National University"
state: Zakarpattia
city: Zaporozhye
country: Ukraine
facility: Municipal Institution Zaporizhzhia Regional Clinical Hospital of Zaporizhzhia Regional Council
state: Zaporizhzhya
city: Dnipropetrovs'k
country: Ukraine
facility: Communal Institution "Dnipropetrovsk Regional Clinical Hospital n.a. I.I. Mechnikov", Regional Center
city: Dnipropetrovs'k
country: Ukraine
facility: Municipal Institution "Dnipropetrovsk Regional Clinical Hospital named after I. I. Mechnikov"
city: Ivano-Frankivs'k
country: Ukraine
facility: Regional Psyconeurology Hospital #3
city: Kharkiv
country: Ukraine
facility: Communal Non-Commercial Enterprise of Kharkiv Regional Council
city: Lviv
country: Ukraine
facility: Municipal Institution of Lviv Regional Council
city: Ternopil'
country: Ukraine
facility: Ternopil Regional Municipal Psychoneurological Hospital
city: Vinnytsya
country: Ukraine
facility: Municipal Institution "Vinnytsia Regional Psychoneurological Hospital named after Acad. O.I. Yushch
Study officials:
affiliation: SK Life Science, Inc.
name: Sunita Misra, MD
role: STUDY_DIRECTOR
References: