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
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:
- unknown adverse drug reactions (ADRs);
- occurrence of ADRs;
- factors that are likely to affect safety and efficacy;
- occurrence of dizziness, balance disorders, ataxia, muscle relaxation-related adverse events, and falls as priority investigation items;
- 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
- 否
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
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