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

Last updated: March 9, 2025
Sponsor: Eisai Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Epilepsy

Treatment

Perampanel Tablet

Perampanel Oral Suspension

Clinical Study ID

NCT04015141
E2007-G000-236
2018-004456-38
  • Ages 1-18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Male or female participants. Cohort 1: age 1 month to less than 18 years; Cohort 2:age 1 month to less than 2 years at the time of informed consent/assent.Participants below the age of 1 year must have been at least 36 weeks of gestationalage at birth.

  • Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) orepilepsy with POS with or without secondary generalization (Cohort 2).

  • Have had equal or greater than 4 seizures over the 4-week interval prior toenrollment visit.

  • Absence of any progressive cause of epilepsy that has been confirmed clinically orbased on brain imaging (example, magnetic resonance imaging [MRI] scan or computedtomography [CT] or ultrasound [for less than 1 year old]).

  • Currently maintained on stable doses of 1 to a maximum of 4 approved antiepilepticdrugs (AEDs). A prescription medical marijuana (including products containingcannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot bethe only concomitant AED if this product is not an approved AED in the country wherethe study site is located. Doses must be stable for at least 4 weeks (at least 2weeks for participant less than [<] 6 months old) before Visit 1/Baseline orscreening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined ascarbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4AEDs is allowed.

Exclusion

Exclusion Criteria:

  • Current or history of pseudo-seizures (psychogenic nonepileptic seizures) withinapproximately 5 years before screening visit.

  • Have a history of status epilepticus that required hospitalization within 6 monthsbefore screening visit.

  • Have an unstable psychiatric diagnosis that may confound participant's ability toparticipate in the study or that may prevent completion of the protocol specifiedtests (example, significant suicide risk, including suicidal behavior and ideationwithin 6 months before screening visit 1, current psychotic disorder, acute mania).

  • Any suicidal ideation with intent with or without a plan within 6 months beforeenrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideationsection of the C-SSRS) in participants aged 6 and above or based on the opinion ofthe Investigator for participants less than 6 years.

  • Are scheduled or confirmed or both to have epilepsy surgery within 6 months afterscreening visit; however, those who have previously documented "failed" epilepsysurgery will be allowed.

  • Have a progressive central nervous system (CNS) disease, including degenerative CNSdiseases and progressive tumors.

  • Benzodiazepines for any indications other than epilepsy (example, anxiety/sleepdisorders) prohibited from 1 month before Visit 1/Baseline or screening and duringthe study. Benzodiazepines for seizure control and as rescue medication are allowed.

  • A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brainstimulator (DBS) implanted less than 5 months before screening visit or changes inparameter less than 4 weeks before screening visit (or thereafter during the study).

  • Use of perampanel within 30 days before screening visit, or perampanel wasdiscontinued due to adverse reactions (perampanel-related) or lack of efficacy incase of previous exposure.

  • Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening).

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Perampanel Tablet
Phase: 2
Study Start date:
May 31, 2019
Estimated Completion Date:
December 23, 2026

Study Description

This study will consist of a Core Study, Extension Phase A and Extension Phase B.

  1. Core Study will consist of the following 2 phases: Pretreatment (4 weeks screening or baseline period) and Treatment Period. The Treatment Period (23 weeks) of Core study include Titration period (10 weeks) and Maintenance period (13 weeks).

  2. Extension Phase A will consist of a Treatment Period (33 weeks) and a Follow-up Period (4 weeks). All participants who will complete the Core Study will be eligible to participate in Extension Phase A of the study.

  3. Extension Phase B will only be for participants who reside in countries where perampanel (oral tablets or oral suspension) is not commercially available or an extended access program (EAP) is not yet implemented, participants have completed Extension Phase A, and who, in the opinion of the investigator, will continue to benefit from treatment with perampanel.

Connect with a study center

  • Centre Neurologique William Lennox

    Ottignies, Brabant Wallon
    Belgium

    Completed

  • UZ Brussel

    Brussel, Brussels
    Belgium

    Completed

  • Cliniques Universitaires Saint-Luc

    Bruxelles, Brussels
    Belgium

    Site Not Available

  • Hôpital Universitaire des Enfants Reine Fabiola

    Bruxelles, Brussels
    Belgium

    Active - Recruiting

  • UZ Gent

    Gent, Oost-Vlaanderen
    Belgium

    Completed

  • Hôpital Erasme

    Anderlecht,
    Belgium

    Site Not Available

  • Fakultni nemocnice Brno

    Brno,
    Czechia

    Completed

  • Fakultni nemocnice Ostrava

    Ostrava,
    Czechia

    Site Not Available

  • Fakultni nemocnice Plzen

    Plzen,
    Czechia

    Site Not Available

  • Aarhus Universitetshospital

    Aarhus N, Central Jutland
    Denmark

    Site Not Available

  • Regionshospitalet Randers

    Randers,
    Denmark

    Site Not Available

  • Hopitaux de La Timone

    Marseille, Bouches-du-Rhône
    France

    Completed

  • Hôpital Pellegrin-Enfants

    Bordeaux,
    France

    Completed

  • Hopital Necker

    Paris,
    France

    Active - Recruiting

  • Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676

    Paris,
    France

    Active - Recruiting

  • CHRU Rennes

    Rennes,
    France

    Active - Recruiting

  • Centre Hospitalier Universitaire de Toulouse

    Toulouse Cedex 9,
    France

    Active - Recruiting

  • Eisai Trial Site #4

    Freiburg,
    Germany

    Completed

  • Eisai Trial Site #2

    Jena,
    Germany

    Active - Recruiting

  • Eisai Trial Site #3

    Munich,
    Germany

    Site Not Available

  • Eisai Trial Site #1

    Radeberg,
    Germany

    Completed

  • Kleinwachau Saechsisches Epilepsiezentrum Radeberg Gemeinnuetzige Gmbh

    Radeberg,
    Germany

    Completed

  • Centro Medico Teknon - Grupo Quironsalud

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid,
    Spain

    Active - Recruiting

  • Complejo Hospitalario de Navarra

    Pamplona,
    Spain

    Active - Recruiting

  • CHUS - H. Clinico U. de Santiago

    Santiago de Compostela,
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen del Rocio

    Sevilla,
    Spain

    Active - Recruiting

  • Phoenix Childrens Hospital

    Phoenix, Arizona 85016
    United States

    Site Not Available

  • Center For Neurosciences

    Tucson, Arizona 85718
    United States

    Site Not Available

  • David Geffen School of Medicine at UCLA

    Los Angeles, California 90095-3075
    United States

    Active - Recruiting

  • Childrens Hospital Colorado

    Aurora, Colorado 80045-7106
    United States

    Active - Recruiting

  • Nemours Foundation Alfred Dupont Children's Hospital

    Wilmington, Delaware 19803
    United States

    Site Not Available

  • Nicklaus Children's Hospital

    Miami, Florida 33155
    United States

    Terminated

  • Pediatric Neurology PA

    Orlando, Florida 32819
    United States

    Site Not Available

  • Pediatric Epilepsy and Neurology Specialists

    Tampa, Florida 33607
    United States

    Active - Recruiting

  • PANDA

    Atlanta, Georgia 30328
    United States

    Site Not Available

  • Meridian Clinical Research-(Savannah Georgia)

    Savannah, Georgia 31406
    United States

    Completed

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Completed

  • Northeast Regional Epilepsy Group

    Hackensack, New Jersey 07601
    United States

    Completed

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • Wake Forest Baptist Medical Center - PPDS

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio 44106
    United States

    Completed

  • Dayton Children's Hospital

    Dayton, Ohio 45404
    United States

    Completed

  • Doernbecher Children's Hospital

    Portland, Oregon 97239
    United States

    Site Not Available

  • Child Neurology Consultants of Austin

    Austin, Texas 78731
    United States

    Completed

  • Road Runner Research Ltd

    San Antonio, Texas 78249
    United States

    Active - Recruiting

  • Children's Specialty Group

    Norfolk, Virginia 23510
    United States

    Completed

  • Children's Hospital of Richmond at VCU - CHoR-PIN

    Richmond, Virginia 23298
    United States

    Completed

  • Seattle Children's Hospital

    Seattle, Washington 98105
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.