NCT06657378招募中不适用
A Multicenter, Postmarketing Observational (Noninterventional) Study to Evaluate the Safety of Fycompa for Injection in Patients With Partial-Onset Seizures (Including Secondarily Generalized Seizures) (Age 4 Years or Older) or Primary Generalized Tonic- Clonic Seizures (Age 12 Years or Older)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Number of Participants With ADRs Based on Participant Characteristic
研究概览
简要总结
The purpose of this study is to determine the safety of Fycompa for injection after administration in participants with epilepsy (partial-onset seizures [including secondarily generalized seizures]) (age 4 years or older) or primary generalized tonic-clonic seizures (age 12 years or older).
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
- 4 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants with epilepsy who received the Fycompa for injection for the first time will be included.
排除标准
- •The exclusion criteria will not be specified in particular because this survey will be conducted in daily clinical practice.
结局指标
主要结局
Number of Participants With ADRs Based on Participant Characteristic
时间窗: Up to 4 weeks
Plasma Concentration of Fycompa in Children Aged Greater Than or Equal to (>=) 4 Years and Less than (<) 12 Years
时间窗: Up to 4 weeks
Number of Participants with Adverse Drug Reactions (ADRs) and Adverse Events (AEs)
时间窗: Up to 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A Study to Evaluate the Safety and Efficacy of Fycompa® (Perampanel) as Add-on Therapy in Participants With EpilepsyPartial-onset SeizuresEpilepsyNCT04230044Eisai Co., Ltd.117
已完成
不适用
A Global, Postmarketing Observational Safety Study to Evaluate the Safety and Tolerability of Fycompa (Perampanel) as Add-on Therapy in Epilepsy Patients Aged Greater Than or Equal to 12 YearsEpilepsyNCT02033902Eisai Inc.500
终止
不适用
Safety and Efficacy of Fibryga in Congenital Fibrinogen DeficiencyCongenital Fibrinogen DeficiencyNCT03793426Octapharma7
已完成
1 期
Pharmacokinetics and Efficacy of Multiple Dosing of Lipovirtide for Injection in HIV-infected PatientsHIV InfectionsNCT05349968Shanxi Kangbao Biological Product Co., Ltd.24
终止
不适用
A Prospective, Post-marketing Registry on the Use of ChondroMimetic for the Repair of Osteochondral DefectsOsteochondral DefectsNCT01209390TiGenix n.v.8