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

NCT04015141 | Active Not Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: E2007-G000-2362018-004456-38
• Study Type: interventional
• Target: 100
• Locations: 6 countries
• Sites: 35

Brief 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).

Conditions

Pediatric Epileptic Syndrome; Partial-onset Seizures

Keywords

Partial-onset seizures; Pediatric epileptic syndrome; Epilepsy; Childhood epilepsy; Epilepsy in children; Refractory seizures; Inadequately controlled seizures; E2007; Fycompa; Perampanel

Outcome Measures

Primary Outcomes (1)

• Proportion of 50% Responders For All Seizures During the Maintenance Period of Core Study

  A response of 50% will be defined as a decrease in 28-day seizure frequency of equal or greater than 50% compared to baseline seizure frequency.

  Week 10 to Week 23

Secondary Outcomes (22)

• Proportion of 50% Responders During Treatment Period of Core Study and Extension Phase A

  Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56

• Proportion of 25% and 75% Responders for all Seizures, During Maintenance Period of Core Study and During Treatment Period of Core Study and Extension Phase A

  Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56

• Proportion of Participants Who Are Seizure-Free During the Maintenance Period of Core Study and During the Treatment Period of Core Study and Extension Phase A

  Maintenance Period of Core study: Week 10 to Week 23; Treatment Period of Core Study and Extension Phase A: Week 0 to Week 56

• Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A

  Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56

• Percent Change From Baseline in Seizure Frequency For All Seizures During the Treatment Period of Core Study and During the Treatment Period of Core Study and Extension Phase A

  Baseline, Treatment Period of Core study: Week 23, Treatment Period of Core Study and Extension Phase A: Week 56

Study Arms (1)

Perampanel

EXPERIMENTAL

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.

Drug: Perampanel Oral Suspension; Drug: Perampanel Tablet

Interventions

Perampanel Oral Suspension DRUG

Perampanel oral suspension.

Also known as: E2007, Fycompa

Perampanel

Perampanel Tablet DRUG

Perampanel tablet.

Also known as: E2007, Fycompa

Perampanel

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (35)

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Nicklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Pediatric Epilepsy and Neurology Specialists

Tampa, Florida, 33607, United States

Location

Meridian Clinical Research-(Savannah Georgia)

Savannah, Georgia, 31406, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Northeast Regional Epilepsy Group

Hackensack, New Jersey, 07601, United States

Location

Wake Forest Baptist Medical Center - PPDS

Winston-Salem, North Carolina, 27157, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Dayton Children's Hospital

Dayton, Ohio, 45404, United States

Location

Child Neurology Consultants of Austin

Austin, Texas, 78731, United States

Location

Road Runner Research Ltd

San Antonio, Texas, 78249, United States

Location

Children's Specialty Group

Norfolk, Virginia, 23510, United States

Location

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

Richmond, Virginia, 23298, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Centre Neurologique William Lennox

Ottignies, Brabant Wallon, Belgium

Location

Hôpital Universitaire des Enfants Reine Fabiola

Brussels, Brussels Capital, Belgium

Location

UZ Brussel

Brussels, Brussels Capital, Belgium

Location

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

Location

Fakultni nemocnice Brno

Brno, Czechia

Location

Hopitaux de La Timone

Marseille, Bouches-du-Rhone, France

Location

Hôpital Pellegrin-Enfants

Bordeaux, France

Location

Hopital Necker

Paris, France

Location

Hopitaux de Paris CHU Hopital Robert Debre - Inserm U676

Paris, France

Location

CHRU Rennes

Rennes, France

Location

Centre Hospitalier Universitaire de Toulouse

Toulouse, France

Location

Universitätsklinikum Freiburg

Freiburg im Breisgau, Germany

Location

Universitätsklinikum Jena

Jena, Germany

Location

Dr. Von Haunersches Kinderspital

Munich, Germany

Location

Kleinwachau Sächsisches Epilepsiezentrum Radeberg Gemeinnützige Gmbh

Radeberg, Germany

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, Spain

Location

CHUS - H. Clinico U. de Santiago

Santiago de Compostela, Spain

Location

Hospital Universitario Virgen del Rocio - PPDS

Seville, Spain

Location

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

perampanel

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: July 10, 2019
• Study Start: May 31, 2019
• Primary Completion (Estimated): April 6, 2027
• Study Completion (Estimated): December 23, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (4); CZ (1); US (15); ES (5); FR (6); BE (4)