Actively Recruiting
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
Led by Eisai Inc. · Updated on 2025-10-09
100
Participants Needed
49
Research Sites
446 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
A Study to Evaluate Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Participants With Childhood Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 time of consent. Participants under 1 year must be at least 36 weeks gestational age at birth.
- Diagnosis of epilepsy with pediatric epileptic syndrome (Cohort 1) or epilepsy with partial-onset seizures (Cohort 2).
- At least 4 seizures during the 4 weeks before enrollment.
- No progressive cause of epilepsy confirmed clinically or by brain imaging.
- Stable doses of 1 to 4 approved antiepileptic drugs for at least 4 weeks (2 weeks if under 6 months old) before baseline. Only 1 enzyme-inducing antiepileptic drug allowed.
You will not qualify if you...
- History or current pseudo-seizures within 5 years before screening.
- History of status epilepticus requiring hospitalization within 6 months before screening.
- Unstable psychiatric diagnosis or significant suicide risk within 6 months before screening.
- Suicidal ideation with intent within 6 months before enrollment (age 6 and above) or per Investigator's opinion (under 6 years).
- Scheduled or confirmed epilepsy surgery within 6 months after screening, except failed prior epilepsy surgery.
- Progressive central nervous system disease or tumors.
- Use of benzodiazepines for non-epilepsy indications from 1 month before baseline and during study.
- Implanted neurostimulator device less than 5 months before screening or recent parameter changes.
- Use of perampanel within 30 days before screening or prior discontinuation due to adverse reactions or lack of efficacy.
- Weight less than 4.0 kg at baseline.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 49 locations
1
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Withdrawn
2
Center For Neurosciences
Tucson, Arizona, United States, 85718
Withdrawn
3
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Actively Recruiting
4
Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Active, Not Recruiting
5
Nemours Foundation Alfred Dupont Children's Hospital
Wilmington, Delaware, United States, 19803
Withdrawn
6
Nicklaus Children's Hospital
Miami, Florida, United States, 33155
Terminated
7
Pediatric Neurology PA
Orlando, Florida, United States, 32819
Withdrawn
8
Pediatric Epilepsy and Neurology Specialists
Tampa, Florida, United States, 33607
Actively Recruiting
9
PANDA Neurology
Atlanta, Georgia, United States, 30328
Withdrawn
10
Meridian Clinical Research-(Savannah Georgia)
Savannah, Georgia, United States, 31406
Completed
11
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Completed
12
Northeast Regional Epilepsy Group
Hackensack, New Jersey, United States, 07601
Completed
13
Columbia University Medical Center
New York, New York, United States, 10032
Withdrawn
14
Wake Forest Baptist Medical Center - PPDS
Winston-Salem, North Carolina, United States, 27157
Active, Not Recruiting
15
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Completed
16
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Completed
17
Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
Withdrawn
18
Child Neurology Consultants of Austin
Austin, Texas, United States, 78731
Completed
19
Road Runner Research Ltd
San Antonio, Texas, United States, 78249
Actively Recruiting
20
Children's Specialty Group
Norfolk, Virginia, United States, 23510
Completed
21
Children's Hospital of Richmond at VCU - CHoR-PIN
Richmond, Virginia, United States, 23298
Completed
22
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
23
Centre Neurologique William Lennox
Ottignies, Brabant Wallon, Belgium
Completed
24
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, Belgium
Withdrawn
25
H�pital Universitaire des Enfants Reine Fabiola
Brussels, Brussels Capital, Belgium
Actively Recruiting
26
UZ Brussel
Brussels, Brussels Capital, Belgium
Completed
27
UZ Gent
Ghent, Oost-Vlaanderen, Belgium
Completed
28
H�pital Erasme
Anderlecht, Belgium
Withdrawn
29
Fakultni nemocnice Brno
Brno, Czechia
Completed
30
Fakultni nemocnice Ostrava
Ostrava, Czechia
Withdrawn
31
Fakultni nemocnice Plzen
Pilsen, Czechia
Withdrawn
32
Aarhus Universitetshospital
Aarhus N, Central Jutland, Denmark
Withdrawn
33
Regionshospitalet Randers
Randers, Denmark
Withdrawn
34
Hopitaux de La Timone
Marseille, Bouches-du-Rhone, France
Completed
35
H�pital Pellegrin-Enfants
Bordeaux, France
Completed
36
Hopital Necker
Paris, France
Actively Recruiting
37
Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676
Paris, France
Actively Recruiting
38
CHRU Rennes
Rennes, France
Active, Not Recruiting
39
Centre Hospitalier Universitaire de Toulouse
Toulouse, France
Actively Recruiting
40
Universit�tsklinikum Freiburg
Freiburg im Breisgau, Germany
Completed
41
Universit�tsklinikum Jena
Jena, Germany
Completed
42
Dr. Von Haunersches Kinderspital
Munich, Germany
Completed
43
Kleinwachau S�chsisches Epilepsiezentrum Radeberg Gemeinn�tzige Gmbh
Radeberg, Germany
Completed
44
Centro Medico Teknon � Grupo Quironsalud
Barcelona, Spain
Withdrawn
45
Hospital Clinico San Carlos
Madrid, Spain
Completed
46
Hospital General Universitario Gregorio Mara�on
Madrid, Spain
Actively Recruiting
47
Complejo Hospitalario de Navarra
Pamplona, Spain
Actively Recruiting
48
CHUS � H. Clinico U. de Santiago
Santiago de Compostela, Spain
Actively Recruiting
49
Hospital Universitario Virgen del Rocio - PPDS
Seville, Spain
Actively Recruiting
Research Team
E
Eisai Medical Information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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