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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
2025-10-09
Healthy Volunteers
No
Interventions
Perampanel Oral Suspension
Perampanel oral suspension.
Perampanel Tablet
Perampanel tablet.
Locations (49)
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Center For Neurosciences
Tucson, Arizona, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, United States
Childrens Hospital Colorado
Aurora, Colorado, United States
Nemours Foundation Alfred Dupont Children's Hospital
Wilmington, Delaware, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Pediatric Neurology PA
Orlando, Florida, United States
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States
PANDA Neurology
Atlanta, Georgia, 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
Columbia University Medical Center
New York, New York, 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
Doernbecher Children's Hospital
Portland, Oregon, 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
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
H�pital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
UZ Brussel
Brussels, Brussels Capital, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
H�pital Erasme
Anderlecht, Belgium
Fakultni nemocnice Brno
Brno, Czechia
Fakultni nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Plzen
Pilsen, Czechia
Aarhus Universitetshospital
Aarhus N, Central Jutland, Denmark
Regionshospitalet Randers
Randers, Denmark
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, France
H�pital 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
Universit�tsklinikum Freiburg
Freiburg im Breisgau, Germany
Universit�tsklinikum Jena
Jena, Germany
Dr. Von Haunersches Kinderspital
Munich, Germany
Kleinwachau S�chsisches Epilepsiezentrum Radeberg Gemeinn�tzige Gmbh
Radeberg, Germany
Centro Medico Teknon � Grupo Quironsalud
Barcelona, Spain
Hospital Clinico San Carlos
Madrid, Spain
Hospital General Universitario Gregorio Mara�on
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