🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT04015141
Active, not recruiting Phase 2

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

NCT04015141 · tracked via the Priya Life Science USA tracker
Sponsor
Eisai Inc.
Phase
Phase 2
Started
2019-05-31
Last updated
2026-07-10

Condition(s) studied

Pediatric Epileptic SyndromePartial-onset Seizures

Investigational drug(s) / intervention(s)

Perampanel Oral SuspensionPerampanel Tablet

Perampanel Oral Suspension: Perampanel oral suspension.

Perampanel Tablet: Perampanel tablet.

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

Sex
ALL
Min age
1 Month
Max age
18 Years
Healthy volunteers
No
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 gestational age at birth. * 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: * Current or history of pseudo-seizures (psychogenic nonepileptic seizures) within approximately 5 years before screening visit. * 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).

Primary outcome measure(s)

Trial sites (35)

FacilityCityRegionStatus
David Geffen School of Medicine at UCLA Los Angeles California
Childrens Hospital Colorado Aurora Colorado
Nicklaus Children's Hospital Miami Florida
Pediatric Epilepsy and Neurology Specialists Tampa Florida
Meridian Clinical Research-(Savannah Georgia) Savannah Georgia
Children's Hospital of Michigan Detroit Michigan
Northeast Regional Epilepsy Group Hackensack New Jersey
Wake Forest Baptist Medical Center - PPDS Winston-Salem North Carolina
University Hospitals Cleveland Medical Center Cleveland Ohio
Dayton Children's Hospital Dayton Ohio
Child Neurology Consultants of Austin Austin Texas
Road Runner Research Ltd San Antonio Texas
Children's Specialty Group Norfolk Virginia
Children's Hospital of Richmond at VCU - CHoR-PIN Richmond Virginia
Seattle Children's Hospital Seattle Washington
Centre Neurologique William Lennox Ottignies Brabant Wallon
Hôpital Universitaire des Enfants Reine Fabiola Brussels Brussels Capital
UZ Brussel Brussels Brussels Capital
UZ Gent Ghent Oost-Vlaanderen
Fakultni nemocnice Brno Brno Czechia
Hopitaux de La Timone Marseille Bouches-du-Rhone
Hôpital 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
Universitätsklinikum Freiburg Freiburg im Breisgau Germany
Universitätsklinikum Jena Jena Germany
Dr. Von Haunersches Kinderspital Munich Germany
Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh Radeberg Germany
Hospital Clinico San Carlos Madrid Spain
Hospital General Universitario Gregorio Marañon 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

More Eisai Inc. trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04015141 on ClinicalTrials.gov ↗ ← All trials in the USA