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ACTIVE NOT RECRUITING
NCT05067634
PHASE3

Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Sponsor: SK Life Science, Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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