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

Who is this study for? Patients with Partial Epilepsy
What treatments are being studied? Xcopri
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

Primary objective: To evaluate the safety and tolerability of cenobamate in pediatric subjects 2-17 years of age with partial-onset (focal) seizures

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 18
Healthy Volunteers: f
View:

• Have a diagnosis of epilepsy with partial-onset (focal) seizures (POS) with or without secondarily generalized seizures according to the International League Against Epilepsy's (ILAE) Classification of Epileptic Seizures. A diagnosis should have been established at least 12 months prior to Visit 1 (Screening) by clinical history and an electroencephalogram (EEG) that is consistent with the diagnosis; normal interictal EEGs will be allowed provided that the participant meets the other diagnosis criterion (i.e., clinical history)

• Male or female participant, from age 2 to less than 18 years at the time of informed consent/assent (dates including informed consent in YKP3089C039)

• Have a minimum weight of 10.0 kilograms (kg) (22.0 pounds \[lb\])

• Have had a brain imaging (e.g., magnetic resonance imaging \[MRI\] scan or computed tomography (CT) within 10 years before Visit 1 (Screening) that ruled out a progressive cause of epilepsy.

• For subjects new to Study YKP3089C040, participants must have had at least 1 POS seizure during the 28-day Baseline Period. Only simple POS with motor signs, complex POS, and complex POS with secondary generalization are counted toward this inclusion for POS

• Are currently being treated with stable doses of 1 to a maximum of 3 approved antiepileptic drugs (AEDs). Doses must be stable for at least 4 weeks before to Visit 1 (Screening). A vagal nerve stimulator \[VNS\] will not be counted as one of the 3 allowed AEDs but the settings should be stable for at least 4 weeks prior to Visit 1 (Screening).

• Investigator believes subject could benefit from new or continued exposure to study drug

• Subjects entering from study YKP3089C039 must continue to meet all of the inclusion criteria from the YKP3089C039 study

• Subjects receiving felbamate as a concomitant AED must meet the following criteria:

∙ Have a 12-month history of felbamate use and a history of a fixed dosing regimen for a minimum of 60 days prior to Visit 1 (Screening).

‣ No prior or known history of hepatotoxicity or hematologic disorder due to felbamate.

⁃ Subjects following a ketogenic diet will be allowed as long as the diet has been stable for at least 30 days prior to Visit 1 (Screening) and will remain stable for the duration of the study

Locations
United States
Arizona
Phoenix Children's Hospital
RECRUITING
Phoenix
California
Lucile Packard Children's Hospital Stanford
RECRUITING
Palo Alto
University of California Davis Health
TERMINATED
Sacramento
Connecticut
Connecticut Children's Medical Center
RECRUITING
Hartford
Georgia
Augusta University Medical Center
TERMINATED
Augusta
Clinical Integrative Research Center of Atlanta
RECRUITING
Sandy Springs
Meridian Clinical Research - Savannah Neurology Specialists
TERMINATED
Savannah
Kentucky
Kentucky Clinic
TERMINATED
Lexington
Massachusetts
Massachusetts General Hospital
WITHDRAWN
Boston
Maryland
Mid-Atlantic Epilepsy and Sleep Center
RECRUITING
Bethesda
Michigan
Spectrum Health Hospitals Helen DeVos Children's Hospital
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic - Rochester
RECRUITING
Rochester
Missouri
University of Missouri Health Care - Women's and Children's Hospital
TERMINATED
Columbia
North Carolina
Duke University Hospital
RECRUITING
Durham
New Jersey
Northeast Regional Epilepsy Group
RECRUITING
Hackensack
Northeast Regional Epilepsy Group - Morristown
RECRUITING
Morristown
New York
Boston Children's Health Physicians - Neurology at Hawthorne
RECRUITING
Hawthorne
Ohio
Akron Children's Hospital NeuroDevelopmental Science Center/Pediatric Neurology
TERMINATED
Akron
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Cleveland Clinic Main Campus
RECRUITING
Cleveland
Pennsylvania
Children's Hospital of Philadelphia
TERMINATED
Philadelphia
Tennessee
Le Bonheur Children's Hospital
RECRUITING
Memphis
Texas
Child Neurology Consultants of Austin
RECRUITING
Austin
Scottish Rite for Children
TERMINATED
Dallas
Washington
MultiCare Institute - Mary Bridge Children's Neurology
RECRUITING
Tacoma
Other Locations
Australia
Austin Health
RECRUITING
Heidelberg
Royal Children's Hospital Melbourne
RECRUITING
Parkville
Sydney Children's Hospital - Randwick
RECRUITING
Randwick
Children's Health Queensland Hospital and Health Service
RECRUITING
South Brisbane
Germany
Charite University Hospital
RECRUITING
Berlin
Diakonie Kork
TERMINATED
Kehl
Universitätsklinikum Schleswig-Holstein - Campus Kiel
TERMINATED
Kiel
Neurologische Klinik und Poliklinik Interdisziplinäres Epilepsiezentrum München
RECRUITING
Munich
Universitätsklinikum Tübingen
TERMINATED
Tübingen
Hungary
Bethesda Gyermekkorhaz
RECRUITING
Budapest
Országos Klinikai Idegtudományi Intézet, Neurológiai Osztály
RECRUITING
Budapest
Semmelweis University Dept. Of Paediatrics
RECRUITING
Budapest
Servus Salvus Egészségügyi Szolgáltató Kft.
RECRUITING
Budapest
Debreceni Egyetem Klinikai Központ
RECRUITING
Debrecen
Poland
Niepubliczny Zaklad Opieki Zdrowotnej - Centrum Neurologii Dzieciecej i Leczenia Padaczki
RECRUITING
Kielce
Centrum Medyczne Plejady
RECRUITING
Krakow
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
TERMINATED
Krakow
Republic of Korea
Chungbuk National University Hospital
RECRUITING
Cheonju
Korea University Guro Hospital
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
SMG-SNU Boramae Medical Center
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
Spain
Hospital Sant Joan de Déu Barcelona
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebrón
RECRUITING
Barcelona
Hospital Infantil Universitario Niño Jesús
RECRUITING
Madrid
Hospital Universitario La Paz
TERMINATED
Madrid
Clinica Universidad de Navarra - Pamplona
TERMINATED
Pamplona
Instituto de Investigación Sanitaria de la Fundación Ramón Domínguez
TERMINATED
Santiago De Compostela
Hospital Universitario Virgen del Rocío
RECRUITING
Seville
Contact Information
Primary
Meagan Whritner
mwhritner@sklsi.com
201-431-7812
Backup
Sunita Misra, MD, PhD
smisra@sklsi.com
Time Frame
Start Date: 2022-01-14
Estimated Completion Date: 2026-07
Participants
Target number of participants: 140
Treatments
Experimental: 12 to < 18 year olds
Experimental: 6 to <12 years old
Experimental: 4 to <6 years old
Experimental: 2 to <4 years old
Related Therapeutic Areas
Sponsors
Leads: SK Life Science, Inc.

This content was sourced from clinicaltrials.gov