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A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
Sponsor: Eisai Inc.
Summary
The purpose of the study is to evaluate the efficacy of perampanel as measured by the 50 percent (%) responder rate during the maintenance period of the core study for seizure frequency in participants with pediatric epileptic syndrome (Cohort 1) and partial-onset seizures (POS) (Cohort 2).
Official title: An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy
Key Details
Gender
All
Age Range
1 Month - 18 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2019-05-31
Completion Date
2027-12-23
Last Updated
2026-07-10
Healthy Volunteers
No
Interventions
Perampanel Oral Suspension
Perampanel oral suspension.
Perampanel Tablet
Perampanel tablet.
Locations (35)
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
Meridian Clinical Research-(Savannah Georgia)
Savannah, Georgia, United States
Children's Hospital of Michigan
Detroit, Michigan, United States
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Dayton Children's Hospital
Dayton, Ohio, United States
Child Neurology Consultants of Austin
Austin, Texas, United States
Road Runner Research Ltd
San Antonio, Texas, United States
Children's Specialty Group
Norfolk, Virginia, United States
Children's Hospital of Richmond at VCU - CHoR-PIN
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Centre Neurologique William Lennox
Ottignies, Brabant Wallon, Belgium
Hôpital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
UZ Brussel
Brussels, Brussels Capital, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Fakultni nemocnice Brno
Brno, Czechia
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, France
Hôpital Pellegrin-Enfants
Bordeaux, France
Hopital Necker
Paris, France
Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676
Paris, France
CHRU Rennes
Rennes, France
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Universitätsklinikum Freiburg
Freiburg im Breisgau, Germany
Universitätsklinikum Jena
Jena, Germany
Dr. Von Haunersches Kinderspital
Munich, Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh
Radeberg, Germany
Hospital Clinico San Carlos
Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Complejo Hospitalario de Navarra
Pamplona, Spain
CHUS - H. Clinico U. de Santiago
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain