期刊
JOURNAL OF CHILD NEUROLOGY
卷 34, 期 5, 页码 284-294出版社
SAGE PUBLICATIONS INC
DOI: 10.1177/0883073819827407
关键词
antiepileptic drugs; efficacy; epilepsy; pediatric; seizures
资金
- Eisai Inc.
Study 232, an open-label pilot study with an extension phase, evaluated the pharmacokinetics and preliminary safety/tolerability and efficacy of adjunctive perampanel oral suspension (<= 0.18 mg/kg/d) in epilepsy patients aged >= 2 to <12 years. Patients were grouped into cohorts 1 (aged >= 7 to <12 years) and 2 (aged >= 2 to <7 years). The Core Study included pretreatment (<= 2 weeks) and treatment phases (7-week titration; 4-week maintenance; 4-week follow-up [for those not entering the extension]). The extension phase consisted of 41-week maintenance and 4-week follow-up periods. Pharmacokinetic data were pooled with adolescent pharmacokinetic data from phase II/III studies. Population pharmacokinetic analysis showed that perampanel pharmacokinetics was independent of age, weight, or liver function, suggesting age- or weight-based dosing is not required and that the same dose can be given to adults and children to achieve exposures shown to be efficacious. Perampanel was well tolerated and efficacious for <= 52 weeks.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据