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

PHASE3RecruitingINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

January 14, 2022

Primary Completion Date

May 31, 2026

Study Completion Date

July 31, 2026

Conditions
Partial Epilepsy
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.

Trial Locations (55)

10532

RECRUITING

Boston Children's Health Physicians - Neurology at Hawthorne, Hawthorne

19104

TERMINATED

Children's Hospital of Philadelphia, Philadelphia

20817

RECRUITING

Mid-Atlantic Epilepsy and Sleep Center, Bethesda

27710

RECRUITING

Duke University Hospital, Durham

30328

RECRUITING

Clinical Integrative Research Center of Atlanta, Sandy Springs

30912

TERMINATED

Augusta University Medical Center, Augusta

31406

TERMINATED

Meridian Clinical Research - Savannah Neurology Specialists, Savannah

38103

RECRUITING

Le Bonheur Children's Hospital, Memphis

40536

TERMINATED

Kentucky Clinic, Lexington

44195

RECRUITING

Cleveland Clinic Main Campus, Cleveland

44308

TERMINATED

Akron Children's Hospital NeuroDevelopmental Science Center/Pediatric Neurology, Akron

45229

RECRUITING

Cincinnati Children's Hospital, Cincinnati

49503

RECRUITING

Spectrum Health Hospitals Helen DeVos Children's Hospital, Grand Rapids

55905

RECRUITING

Mayo Clinic - Rochester, Rochester

65212

TERMINATED

University of Missouri Health Care - Women's and Children's Hospital, Columbia

75219

TERMINATED

Scottish Rite for Children, Dallas

78731

RECRUITING

Child Neurology Consultants of Austin, Austin

85016

RECRUITING

Phoenix Children's Hospital, Phoenix

94304

RECRUITING

Lucile Packard Children's Hospital Stanford, Palo Alto

95817

TERMINATED

University of California Davis Health, Sacramento

98405

RECRUITING

MultiCare Institute - Mary Bridge Children's Neurology, Tacoma

06106

RECRUITING

Connecticut Children's Medical Center, Hartford

02114

WITHDRAWN

Massachusetts General Hospital, Boston

07601

RECRUITING

Northeast Regional Epilepsy Group, Hackensack

07960

RECRUITING

Northeast Regional Epilepsy Group - Morristown, Morristown

Unknown

RECRUITING

Austin Health, Heidelberg

RECRUITING

Royal Children's Hospital Melbourne, Parkville

RECRUITING

Sydney Children's Hospital - Randwick, Randwick

RECRUITING

Children's Health Queensland Hospital and Health Service, South Brisbane

RECRUITING

Charite University Hospital, Berlin

TERMINATED

Diakonie Kork, Kehl

TERMINATED

Universitätsklinikum Schleswig-Holstein - Campus Kiel, Kiel

RECRUITING

Neurologische Klinik und Poliklinik Interdisziplinäres Epilepsiezentrum München, Munich

TERMINATED

Universitätsklinikum Tübingen, Tübingen

RECRUITING

Bethesda Gyermekkorhaz, Budapest

RECRUITING

Országos Klinikai Idegtudományi Intézet, Neurológiai Osztály, Budapest

RECRUITING

Semmelweis University Dept. Of Paediatrics, Budapest

RECRUITING

Servus Salvus Egészségügyi Szolgáltató Kft., Budapest

RECRUITING

Debreceni Egyetem Klinikai Központ, Debrecen

RECRUITING

Niepubliczny Zaklad Opieki Zdrowotnej - Centrum Neurologii Dzieciecej i Leczenia Padaczki, Kielce

RECRUITING

Centrum Medyczne Plejady, Krakow

TERMINATED

Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie, Krakow

RECRUITING

Chungbuk National University Hospital, Cheonju

RECRUITING

Korea University Guro Hospital, Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Severance Hospital, Seoul

RECRUITING

SMG-SNU Boramae Medical Center, Seoul

RECRUITING

Ajou University Hospital, Suwon

RECRUITING

Hospital Sant Joan de Déu Barcelona, Barcelona

RECRUITING

Hospital Universitari Vall d'Hebrón, Barcelona

RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

TERMINATED

Hospital Universitario La Paz, Madrid

TERMINATED

Clinica Universidad de Navarra - Pamplona, Pamplona

TERMINATED

Instituto de Investigación Sanitaria de la Fundación Ramón Domínguez, Santiago de Compostela

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

All Listed Sponsors
lead

SK Life Science, Inc.

INDUSTRY