Phase
Condition
Epilepsy
Treatment
Perampanel Tablet
Perampanel Oral Suspension
Clinical Study ID
Ages 1-18 All Genders
Study Summary
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
Study Description
Connect with a study center
Centre Neurologique William Lennox
Ottignies, Brabant Wallon
BelgiumCompleted
UZ Brussel
Brussel, Brussels
BelgiumCompleted
Cliniques Universitaires Saint-Luc
Bruxelles, Brussels
BelgiumSite Not Available
Hôpital Universitaire des Enfants Reine Fabiola
Bruxelles, Brussels
BelgiumActive - Recruiting
UZ Gent
Gent, Oost-Vlaanderen
BelgiumCompleted
Hôpital Erasme
Anderlecht,
BelgiumSite Not Available
Fakultni nemocnice Brno
Brno,
CzechiaCompleted
Fakultni nemocnice Ostrava
Ostrava,
CzechiaSite Not Available
Fakultni nemocnice Plzen
Plzen,
CzechiaSite Not Available
Aarhus Universitetshospital
Aarhus N, Central Jutland
DenmarkSite Not Available
Regionshospitalet Randers
Randers,
DenmarkSite Not Available
Hopitaux de La Timone
Marseille, Bouches-du-Rhône
FranceCompleted
Hôpital Pellegrin-Enfants
Bordeaux,
FranceCompleted
Hopital Necker
Paris,
FranceActive - Recruiting
Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676
Paris,
FranceActive - Recruiting
CHRU Rennes
Rennes,
FranceActive - Recruiting
Centre Hospitalier Universitaire de Toulouse
Toulouse Cedex 9,
FranceActive - Recruiting
Eisai Trial Site #4
Freiburg,
GermanyCompleted
Eisai Trial Site #2
Jena,
GermanyActive - Recruiting
Eisai Trial Site #3
Munich,
GermanySite Not Available
Eisai Trial Site #1
Radeberg,
GermanyCompleted
Kleinwachau Saechsisches Epilepsiezentrum Radeberg Gemeinnuetzige Gmbh
Radeberg,
GermanyCompleted
Centro Medico Teknon - Grupo Quironsalud
Barcelona,
SpainSite Not Available
Hospital Clinico San Carlos
Madrid,
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañón
Madrid,
SpainActive - Recruiting
Complejo Hospitalario de Navarra
Pamplona,
SpainActive - Recruiting
CHUS - H. Clinico U. de Santiago
Santiago de Compostela,
SpainActive - Recruiting
Hospital Universitario Virgen del Rocio
Sevilla,
SpainActive - Recruiting
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United StatesSite Not Available
Center For Neurosciences
Tucson, Arizona 85718
United StatesSite Not Available
David Geffen School of Medicine at UCLA
Los Angeles, California 90095-3075
United StatesActive - Recruiting
Childrens Hospital Colorado
Aurora, Colorado 80045-7106
United StatesActive - Recruiting
Nemours Foundation Alfred Dupont Children's Hospital
Wilmington, Delaware 19803
United StatesSite Not Available
Nicklaus Children's Hospital
Miami, Florida 33155
United StatesTerminated
Pediatric Neurology PA
Orlando, Florida 32819
United StatesSite Not Available
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida 33607
United StatesActive - Recruiting
PANDA
Atlanta, Georgia 30328
United StatesSite Not Available
Meridian Clinical Research-(Savannah Georgia)
Savannah, Georgia 31406
United StatesCompleted
Children's Hospital of Michigan
Detroit, Michigan 48201
United StatesCompleted
Northeast Regional Epilepsy Group
Hackensack, New Jersey 07601
United StatesCompleted
Columbia University Medical Center
New York, New York 10032
United StatesSite Not Available
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina 27157
United StatesSite Not Available
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United StatesCompleted
Dayton Children's Hospital
Dayton, Ohio 45404
United StatesCompleted
Doernbecher Children's Hospital
Portland, Oregon 97239
United StatesSite Not Available
Child Neurology Consultants of Austin
Austin, Texas 78731
United StatesCompleted
Road Runner Research Ltd
San Antonio, Texas 78249
United StatesActive - Recruiting
Children's Specialty Group
Norfolk, Virginia 23510
United StatesCompleted
Children's Hospital of Richmond at VCU - CHoR-PIN
Richmond, Virginia 23298
United StatesCompleted
Seattle Children's Hospital
Seattle, Washington 98105
United StatesActive - Recruiting
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