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ACTIVE NOT RECRUITING
NCT04015141
PHASE2

A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

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

DRUG

Perampanel Oral Suspension

Perampanel oral suspension.

DRUG

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