NCT03059381已完成不适用
Investigation of the Clinical Safety and Efficacy of Long-term Treatment With Fycompa Tablets in Adolescence 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
- 519
- 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 adolescent 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
- 12 Years 至 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Epilepsy participants from 12 to 17 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
Adolescent 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 104 weeks
Number of participants with any non-serious adverse event
时间窗: from 0 to 104 weeks
次要结局
- Number of participants experiencing seizures(from 0 to 104 weeks)
- Overall improvement rating in seizure frequency(from 0 to 104 weeks)
研究者
相似试验
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 SeizuresPartial Seizures (With or Without Secondary Generalized Seizures)Primary Generalized Tonic-clonic SeizuresNCT03059329Eisai Co., Ltd.3,809
已完成
不适用
The Effectiveness and Safety of Vagus Nerve Stimulation for TRETuberous Sclerosis ComplexEpilepsyNCT04198207Beijing Children's Hospital70
进行中(未招募)
不适用
The Effectiveness and Safety of Resective Epilepsy Surgery for TRETuberous Sclerosis ComplexEpilepsyNCT04198181Beijing Children's Hospital200
Unknown
4 期
A Prospective Safety and Effectiveness Study of a New High Repetition Rate Excimer Laser Using LASIK for the Correction of Ammetropia and PresbyopiaHyperopiaPresbyopiaMyopiaNCT02112968Technolas Perfect Vision GmbH97
Unknown
4 期
A Prospective Safety and Effectiveness Study of the 500 Hz Technolas Perfect Vision Excimer Laser in Asian Eyes Using LASIKMyopiaHyperopiaPresbyopiaNCT01977807Technolas Perfect Vision GmbH100
