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Title: | Review of clinical studies of perampanel in adolescent patients | Authors: | 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 Lee, W.-T Yung, A Dash, A |
Keywords: | AMPA receptor perampanel placebo abnormal behavior adolescent aggression anger asthenia cognition convulsion decreased appetite dizziness drug dose titration drug tolerability drug withdrawal fatigue follow up growth half life time human irritability maintenance therapy multicenter study (topic) phase 2 clinical trial (topic) phase 3 clinical trial (topic) priority journal randomized controlled trial (topic) Review rhinitis risk benefit analysis seizure somnolence |
Issue Date: | 2016 | Citation: | 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, Lee, W.-T, Yung, A, Dash, A (2016). Review of clinical studies of perampanel in adolescent patients. Brain and Behavior 6 (9) : e00505. ScholarBank@NUS Repository. https://doi.org/10.1002/brb3.505 | Rights: | Attribution 4.0 International | 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. © 2016 The Authors. Brain and Behavior published by Wiley Periodicals, Inc. | Source Title: | Brain and Behavior | URI: | https://scholarbank.nus.edu.sg/handle/10635/183320 | ISSN: | 21623279 | DOI: | 10.1002/brb3.505 | Rights: | Attribution 4.0 International |
Appears in Collections: | Staff Publications Elements |
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