NCT04015141

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

An Open-Label Study With Extension Phase to Evaluate the Efficacy and Safety of Perampanel Administered as an Adjunctive Therapy in Pediatric Subjects (Age 1 Month to Less Than 18 Years) With Childhood Epilepsy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Eisai Inc. · Industry
• Sex: All
• Age: 1 Month – 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This study will consist of a Core Study, Extension Phase A and Extension Phase B. 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

• Pediatric Epileptic Syndrome
• Partial-onset Seizures

Interventions

Type	Name	Description
DRUG	Perampanel Oral Suspension	Perampanel oral suspension.
DRUG	Perampanel Tablet	Perampanel tablet.

Timeline

• Start date: 2019-05-31
• Primary completion: 2027-04-06
• Completion: 2027-12-23
• First posted: 2019-07-10
• Last updated: 2025-10-09

Locations

49 sites across 7 countries: United States, Belgium, Czechia, Denmark, France, Germany, Spain

Regulatory

• FDA-regulated drug study