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Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Sponsor: SK Life Science, Inc.
Summary
Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures
Official title: Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
Key Details
Gender
All
Age Range
2 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2022-01-14
Completion Date
2026-11
Last Updated
2026-04-03
Healthy Volunteers
No
Conditions
Interventions
Xcopri
Age groups 12 to \<18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to \<12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to \<6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to \<4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
Locations (54)
Phoenix Children's Hospital
Phoenix, Arizona, United States
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States
University of California Davis Health
Sacramento, California, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Augusta University Medical Center
Augusta, Georgia, United States
Clinical Integrative Research Center of Atlanta
Sandy Springs, Georgia, United States
Meridian Clinical Research - Savannah Neurology Specialists
Savannah, Georgia, United States
Kentucky Clinic
Lexington, Kentucky, United States
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland, United States
Spectrum Health Hospitals Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
University of Missouri Health Care - Women's and Children's Hospital
Columbia, Missouri, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Northeast Regional Epilepsy Group - Morristown
Morristown, New Jersey, United States
Boston Children's Health Physicians - Neurology at Hawthorne
Hawthorne, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Akron Children's Hospital NeuroDevelopmental Science Center/Pediatric Neurology
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Cleveland Clinic Main Campus
Cleveland, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Le Bonheur Children's Hospital
Memphis, Tennessee, United States
Child Neurology Consultants of Austin
Austin, Texas, United States
Scottish Rite for Children
Dallas, Texas, United States
MultiCare Institute - Mary Bridge Children's Neurology
Tacoma, Washington, United States
Austin Health
Heidelberg, Australia
Royal Children's Hospital Melbourne
Parkville, Australia
Sydney Children's Hospital - Randwick
Randwick, Australia
Children's Health Queensland Hospital and Health Service
South Brisbane, Australia
Charite University Hospital
Berlin, Germany
Diakonie Kork
Kehl, Germany
Universitätsklinikum Schleswig-Holstein - Campus Kiel
Kiel, Germany
Neurologische Klinik und Poliklinik Interdisziplinäres Epilepsiezentrum München
Munich, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Bethesda Gyermekkorhaz
Budapest, Hungary
Országos Klinikai Idegtudományi Intézet, Neurológiai Osztály
Budapest, Hungary
Semmelweis University Dept. Of Paediatrics
Budapest, Hungary
Servus Salvus Egészségügyi Szolgáltató Kft.
Budapest, Hungary
Debreceni Egyetem Klinikai Központ
Debrecen, Hungary
Niepubliczny Zaklad Opieki Zdrowotnej - Centrum Neurologii Dzieciecej i Leczenia Padaczki
Kielce, Poland
Centrum Medyczne Plejady
Krakow, Poland
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, Poland
Chungbuk National University Hospital
Cheonju, South Korea
Korea University Guro Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital
Seoul, South Korea
SMG-SNU Boramae Medical Center
Seoul, South Korea
Ajou University Hospital
Suwon, South Korea
Hospital Sant Joan de Déu Barcelona
Barcelona, Spain
Hospital Universitari Vall d'Hebrón
Barcelona, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, Spain
Hospital Universitario La Paz
Madrid, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Spain
Instituto de Investigación Sanitaria de la Fundación Ramón Domínguez
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain