Open AccessReview of clinical studies of perampanel in adolescent patients
Author(s) -
Kim Heung Dong,
Chi ChingShiang,
Desudchit Tayard,
Nikanorova Marina,
Visudtibhan Anannit,
Nabangchang Charcrin,
Chan Derrick W. S.,
Fong Choong Yi,
Chang KaiPing,
Kwan ShangYeong,
Reyes Fe De Los,
Huang ChaoChing,
Likasitwattanakul Surachai,
Lee WangTso,
Yung Ada,
Dash Amitabh
Publication year - 2016
Publication title -
brain and behavior
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.915
H-Index - 41
ISSN - 2162-3279
DOI - 10.1002/brb3.505
Subject(s) - perampanel , epilepsy , tolerability , clinical trial , placebo , medicine , population , adjunctive treatment , psychology , psychiatry , pediatrics , adverse effect , pharmacology , alternative medicine , environmental health , pathology
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.