RecruitingPhase 2NCT04015141

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

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


Sponsor

Eisai Inc.

Enrollment

100 participants

Start Date

May 31, 2019

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 1 MonthMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Perampanel Oral Suspension and a drug called Perampanel Tablet for people with partial-onset seizures and pediatric epileptic syndrome. The study is currently recruiting participants at 49 locations. People eligible for this study include aged 1 Month to 18 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPerampanel Oral Suspension

Perampanel oral suspension.

DRUGPerampanel 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

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NCT04015141


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