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Review of clinical studies of perampanel in adolescent patients

Authors :
Shang Yeong Kwan
Anannit Visudtibhan
Amitabh Dash
Ada Yung
Tayard Desudchit
Surachai Likasitwattanakul
Kai Ping Chang
Fe De Los Reyes
Heung Dong Kim
Wang-Tso Lee
Marina Nikanorova
Chao Ching Huang
Ching Shiang Chi
Derrick Chan
Charcrin Nabangchang
Choong Yi Fong
Source :
Brain and Behavior
Publication Year :
2016
Publisher :
Wiley, 2016.

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.

Details

ISSN :
21623279
Volume :
6
Database :
OpenAIRE
Journal :
Brain and Behavior
Accession number :
edsair.doi.dedup.....7f8342e8b4d5f7c61c721e54a85babbc
Full Text :
https://doi.org/10.1002/brb3.505