Review of clinical studies of perampanel in adolescent patients

Heung Dong Kim, Ching Shiang Chi, Tayard Desudchit, Marina Nikanorova, Anannit Visudtibhan, Charcrin Nabangchang, Derrick W S Chan, Choong Yi Fong, Kai Ping Chang, Shang Yeong Kwan, Fe De Los Reyes, Chao Ching Huang, Surachai Likasitwattanakul, Wang Tso Lee, Ada Yung, Amitabh Dash

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8 引文 斯高帕斯(Scopus)

摘要

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.
原文英語
文章編號e00505
期刊Brain and Behavior
6
發行號9
DOIs
出版狀態已發佈 - 九月 1 2016

ASJC Scopus subject areas

  • Behavioral Neuroscience

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    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. D. L., Huang, C. C., Likasitwattanakul, S., Lee, W. T., Yung, A., & Dash, A. (2016). Review of clinical studies of perampanel in adolescent patients. Brain and Behavior, 6(9), [e00505]. https://doi.org/10.1002/brb3.505