A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
NCT ID: NCT04015141
Last Updated: 2025-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
100 participants
INTERVENTIONAL
2019-05-31
2027-12-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Perampanel
Participants aged 1 month to less than 18 years with pediatric epileptic syndrome (Cohort 1) or aged 1 month to less than 2 years with POS (Cohort 2) will receive perampanel oral suspension or perampanel tablets, once daily up to 56 weeks.
Perampanel Oral Suspension
Perampanel oral suspension.
Perampanel Tablet
Perampanel tablet.
Interventions
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Perampanel Oral Suspension
Perampanel oral suspension.
Perampanel Tablet
Perampanel tablet.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of epilepsy with a pediatric epileptic syndrome (Cohort 1) or epilepsy with POS with or without secondary generalization (Cohort 2).
* Have had equal or greater than 4 seizures over the 4-week interval prior to enrollment visit.
* Absence of any progressive cause of epilepsy that has been confirmed clinically or based on brain imaging (example, magnetic resonance imaging \[MRI\] scan or computed tomography \[CT\] or ultrasound \[for less than 1 year old\]).
* Currently maintained on stable doses of 1 to a maximum of 4 approved antiepileptic drugs (AEDs). A prescription medical marijuana (including products containing cannabidiol) is counted as 1 of the maximum of 4 allowed AEDs; however, it cannot be the only concomitant AED if this product is not an approved AED in the country where the study site is located. Doses must be stable for at least 4 weeks (at least 2 weeks for participant less than \[\<\] 6 months old) before Visit 1/Baseline or screening; only 1 enzyme-inducing antiepileptic drug (EIAED) (defined as carbamazepine, phenytoin, oxcarbazepine, or eslicarbazepine) out of the maximum of 4 AEDs is allowed.
Exclusion Criteria
* Have a history of status epilepticus that required hospitalization within 6 months before screening visit.
* Have an unstable psychiatric diagnosis that may confound participant's ability to participate in the study or that may prevent completion of the protocol specified tests (example, significant suicide risk, including suicidal behavior and ideation within 6 months before screening visit 1, current psychotic disorder, acute mania).
* Any suicidal ideation with intent with or without a plan within 6 months before enrollment visit (answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the C-SSRS) in participants aged 6 and above or based on the opinion of the Investigator for participants less than 6 years.
* Are scheduled or confirmed or both to have epilepsy surgery within 6 months after screening visit; however, those who have previously documented "failed" epilepsy surgery will be allowed.
* Have a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
* Benzodiazepines for any indications other than epilepsy (example, anxiety/sleep disorders) prohibited from 1 month before Visit 1/Baseline or screening and during the study. Benzodiazepines for seizure control and as rescue medication are allowed.
* A vagal nerve stimulator (VNS), responsive neurostimulator (RNS), or deep brain stimulator (DBS) implanted less than 5 months before screening visit or changes in parameter less than 4 weeks before screening visit (or thereafter during the study).
* Use of perampanel within 30 days before screening visit, or perampanel was discontinued due to adverse reactions (perampanel-related) or lack of efficacy in case of previous exposure.
* Weight less than 4.0 kilogram (kg) at Visit 1 (Baseline or screening).
1 Month
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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2018-004456-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
E2007-G000-236
Identifier Type: -
Identifier Source: org_study_id
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