NCT03836924已完成不适用
A Prospective, Multicenter, Post-marketing Surveillance to Assess Safety & Efficacy of Perampanel in Indian Patients as An Adjunctive Treatment in Partial Onset Seizures With or Without Secondary Generalized Seizures in Patients With Epilepsy Aged 12 Years or Older
Eisai Pharmaceuticals India Pvt. Ltd12 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2019年2月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 12
- 主要终点
- Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to assess the safety of perampanel in the treatment of partial onset seizures in participants of age 12 years and older with epilepsy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants prescribed perampanel for the adjunctive treatment of partial onset seizures based on independent clinical judgment of treating physicians.
排除标准
- •Participation in another study involving administration of an investigational drug or device whilst participating in this observational study.
- •Hypersensitivity [allergic] to perampanel.
研究组 & 干预措施
Perampanel
Participants receiving perampanel tablets, orally according to prescribing information and the treating physician's clinical judgment will be observed prospectively for up to 6 months or participant withdrawal, whichever occurs first.
干预措施: Perampanel (Drug)
结局指标
主要结局
Number of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
时间窗: Up to 6 months
次要结局
- Percent Change From Baseline in Seizure Frequency per 28 days During the Treatment Period(Up to 6 months)
- Percentage of Participants Who Achieved a Seizure-free Status During the Treatment Period(At 3 months and 6 months)
- Percentage of Participants Who Experienced at Least 50 Percent Reduction From Baseline in Seizure Frequency During the Treatment Period(Up to 6 months)
研究者
研究点 (12)
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