Review of clinical studies of perampanel in adolescent patients

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...

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Published in:Brain and behavior 2016-09, Vol.6 (9), p.e00505-n/a
Main Authors: Kim, Heung Dong, Chi, Ching‐Shiang, Desudchit, Tayard, Nikanorova, Marina, Visudtibhan, Anannit, Nabangchang, Charcrin, Chan, Derrick W. S., Fong, Choong Yi, Chang, Kai‐Ping, Kwan, Shang‐Yeong, Reyes, Fe De Los, Huang, Chao‐Ching, Likasitwattanakul, Surachai, Lee, Wang‐Tso, Yung, Ada, Dash, Amitabh
Format: Article
Language:English
Subjects:
Adolescent
Age
Anticonvulsants
Clinical medicine
Clinical trials
Cognition & reasoning
consensus
Convulsions & seizures
Drug dosages
Epilepsy
Patients
perampanel
receptors AMPA
Review
Reviews
Teenagers
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Summary: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. This review sets the consensus treatment recommendations to guide the use of perampanel in adolescent epileptic patients ≥12 years of age. 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 which has been published was reviewed and practical considerations were recommended for appropriate use in adolescent patients.
ISSN:2162-3279
2162-3279
DOI:10.1002/brb3.505