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

What this Trial Is About

Researchers are evaluating the efficacy of perampanel as an additional therapy for children and adolescents with pediatric epileptic syndrome and partial-onset seizures. The study aims to measure how well perampanel reduces seizure frequency, focusing on the 50% responder rate during the maintenance phase of the core study. This phase 2, open-label trial includes participants from 1 month to less than 18 years old with specific epilepsy diagnoses. The study includes a Core Study and two Extension Phases. The Core Study starts with a 4-week screening period, followed by a 23-week treatment period divided into a 10-week titration phase and a 13-week maintenance phase. Participants receive perampanel oral suspension or tablets once daily for up to 56 weeks. Those completing the Core Study may join Extension Phase A, which has a 33-week treatment period and a 4-week follow-up. Extension Phase B is available for participants in areas without commercial perampanel or extended access programs, continuing treatment as deemed beneficial by investigators. Throughout the study, participants will undergo regular assessments including seizure frequency monitoring, cognitive and behavioral evaluations, growth and development measurements, and safety checks such as vital signs, laboratory tests, and electroencephalograms. Researchers will track responders who achieve seizure reductions and evaluate overall clinical impressions and drug effects. Participation may last up to about 60 weeks, including all phases and follow-up periods, with careful monitoring of adverse events and treatment impact.

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