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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 th...

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Autores principales: 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5036429/
https://www.ncbi.nlm.nih.gov/pubmed/27688936
http://dx.doi.org/10.1002/brb3.505
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author 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
author_facet 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
author_sort Kim, Heung Dong
collection PubMed
description 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.
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spelling pubmed-50364292016-09-29 Review of clinical studies of perampanel in adolescent patients 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 Brain Behav Reviews 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. John Wiley and Sons Inc. 2016-06-28 /pmc/articles/PMC5036429/ /pubmed/27688936 http://dx.doi.org/10.1002/brb3.505 Text en © 2016 The Authors. Brain and Behavior published by Wiley Periodicals, Inc. This is an open access article under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Reviews
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
Review of clinical studies of perampanel in adolescent patients
title Review of clinical studies of perampanel in adolescent patients
title_full Review of clinical studies of perampanel in adolescent patients
title_fullStr Review of clinical studies of perampanel in adolescent patients
title_full_unstemmed Review of clinical studies of perampanel in adolescent patients
title_short Review of clinical studies of perampanel in adolescent patients
title_sort review of clinical studies of perampanel in adolescent patients
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5036429/
https://www.ncbi.nlm.nih.gov/pubmed/27688936
http://dx.doi.org/10.1002/brb3.505
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