JPRN-UMIN000044131已完成未知
An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study - An Open-label, Observational, Prospective, Multicenter Study to Evaluate the LOng-teRm Efficacy and SafeTy of PerAmpanel as Monotherapy in SuBjects Age 4 Years and Older with FocaL Onset Seizures:PORTABLE Study
International University of Health and Welfare and Eisai Co., Ltd0 个研究点目标入组 60 人开始时间: 2021年5月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 4years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1) A history of receiving any AED (including AED used as rescue treatment) for more than 2 weeks in total within 2 years 2) Previously treated with perampanel at any time 3) A history of hypersensitivity to any of the excipients of perampanel 4) Severe hepatic impairment(Child-Pugh Score:C) 5) Subjects who have participated in a study involving administration of an investigational drug/biologics or device within 4 weeks 6) Not appropriate for the study according to the judgment of the investigator
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