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临床试验/NCT03059329
NCT03059329已完成不适用

Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adult Epilepsy Patients With Partial-onset Seizures (With or Without Secondary Generalized Seizures) or Primary Generalized Tonic-clonic Seizures

Eisai Co., Ltd.0 个研究点目标入组 3,809 人开始时间: 2016年8月1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
入组人数
3,809
主要终点
Number of participants with any serious adverse event

研究概览

简要总结

The objective of this study is to identify the following in adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa:

  1. unknown adverse drug reactions (ADRs);
  2. occurrence of ADRs;
  3. factors that are likely to affect safety and efficacy;
  4. occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
  5. occurrence of psychiatric adverse events as priority investigation items (eg, aggression).

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Epilepsy participants at least 18 years of age with:
  • Partial seizures (with or without secondary generalized seizures)
  • Primary generalized Tonic-clonic seizures

排除标准

  • Participants previously treated with Fycompa

研究组 & 干预措施

Fycompa-treated epilepsy participants

Adult epilepsy participants with partial-onset seizures (with or without secondary generalized seizures) or primary generalized Tonic-clonic seizures who receive long-term treatment with Fycompa

干预措施: Fycompa (Drug)

结局指标

主要结局

Number of participants with any serious adverse event

时间窗: from 0 to 52 weeks

Number of participants with any non-serious adverse event

时间窗: from 0 to 52 weeks

次要结局

  • Number of participants experiencing seizures(from 0 to 52 weeks)
  • Overall improvement rating in seizure frequency(from 0 to 52 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

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