Review of clinical studies of perampanel in adolescent patients

被引:11
作者
Kim, Heung Dong [1 ]
Chi, Ching-Shiang [2 ]
Desudchit, Tayard [3 ]
Nikanorova, Marina [4 ]
Visudtibhan, Anannit [5 ]
Nabangchang, Charcrin [6 ]
Chan, Derrick W. S. [7 ]
Fong, Choong Yi [8 ]
Chang, Kai-Ping [9 ]
Kwan, Shang-Yeong [10 ]
De Los Reyes, Fe [11 ]
Huang, Chao-Ching [12 ]
Likasitwattanakul, Surachai [13 ]
Lee, Wang-Tso [14 ]
Yung, Ada [15 ]
Dash, Amitabh [16 ]
机构
[1] Yonsei Univ, Div Pediat Neurol, Severance Childrens Hosp, Seoul, South Korea
[2] Tungs Taichung Metro Harbor Hosp, Dept Pediat, Taichung, Taiwan
[3] King Chulalongkorn Mem Hosp, Dept Paediat Neurol, Bangkok, Thailand
[4] Danish Epilepsy Ctr Filadelfia, Childrens Dept, Dianalund, Denmark
[5] Mahidol Univ, Div Neurol, Dept Pediat, Fac Med,Ramathibodi Hosp, Bangkok, Thailand
[6] Phramongkutklao Hosp, Dept Paediat, Bangkok, Thailand
[7] KK Womens & Childrens Hosp, Dept Paediat, Singapore, Singapore
[8] Univ Malaya, Div Paediat Neurol, Dept Paediat, Fac Med, Kuala Lumpur, Malaysia
[9] Taipei Vet Gen Hosp, Dept Pediat, Taipei, Taiwan
[10] Taipei Vet Gen Hosp, Dept Neurol, Taipei, Taiwan
[11] Mother Seton Hosp, Dept Pediat, Camarines Sur, Philippines
[12] Taipei Med Univ, Dept Pediat, Coll Med, Taipei, Taiwan
[13] Mahidol Univ, Dept Pediat, Fac Med, Siriraj Hosp, Bangkok, Thailand
[14] Natl Taiwan Univ Hosp, Dept Pediat, Taipei, Taiwan
[15] Duchess Kent Childrens Hosp, Dept Pediat, Sandy Bay, Hong Kong, Peoples R China
[16] Eisai Pharmaceut India Pvt Ltd, Bombay, Maharashtra, India
关键词
Adolescent; Anticonvulsants; consensus; epilepsy; perampanel; receptors AMPA; PARTIAL-ONSET SEIZURES; RANDOMIZED PHASE-III; ADJUNCTIVE PERAMPANEL; RECEPTOR ANTAGONIST;
D O I
10.1002/brb3.505
中图分类号
B84 [心理学]; C [社会科学总论]; Q98 [人类学];
学科分类号
03 ; 0303 ; 030303 ; 04 ; 0402 ;
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.
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页数:9
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