Review of clinical studies of perampanel in adolescent patients
Journal
Brain and Behavior
Journal Volume
6
Journal Issue
9
Pages
e00505
Date Issued
2016
Author(s)
Kim H.D.
Chi C.-S.
Desudchit T.
Nikanorova M.
Visudtibhan A.
Nabangchang C.
Chan D.W.S.
Fong C.Y.
Chang K.-P.
Kwan S.-Y.
Reyes F.L.
Huang C.-C.
Likasitwattanakul S.
Yung A.
Dash A.
Abstract
AIM: To assess the clinical trial and real-world data for adjunctive perampanel in adolescents and develop consensus recommendations to guide the use of perampanel in this population in clinical practice. METHODS: In May 2015, 15 epilepsy experts attended a Consensus Development Meeting to assess the clinical trial data for perampanel, specific to the adolescent age group (12-17 years) and develop consensus treatment recommendations. RESULTS AND DISCUSSION: Analysis of the adolescent subgroup data of three pivotal placebo-controlled, double-blind, phase 3 trials investigating perampanel in patients with ongoing focal epileptic seizures despite receiving one to three antiepileptic drugs found that perampanel 4-12 mg was superior to placebo. The tolerability profile of perampanel was generally acceptable. Adolescent patients receiving long-term treatment with perampanel in an open-label extension study maintained improvements in seizure control compared with baseline, with a favorable risk-benefit profile. A phase 2 study showed that perampanel had no clinically important effects on cognitive function, growth, and development. CONCLUSION: Perampanel is a welcome addition to the armamentarium of existing antiepileptic drugs as it represents a new approach in the management of epilepsy, with a novel mechanism of action, and the potential to have a considerable impact on the treatment of adolescents with epilepsy.
SDGs
Publisher
John Wiley and Sons Ltd
Type
review