Post-Marketing Surveillance of Fycompa in Korean Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,692
- 主要终点
- Number of Participants With Serious Adverse Events
研究概览
简要总结
The purpose of this post-marketing surveillance is to observe the following items regarding the safety profile of Fycompa (Perampanel) film-coated tablets and oral suspension in normal clinical practice setting: serious adverse event/adverse drug reaction profile, unexpected adverse event/adverse drug reaction profile, already known adverse drug reaction profile, non-serious adverse event profile and other information related to the product's safety and effectiveness.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 approved indication for Fycompa (Perampanel) in Korea as follows:
- •Monotherapy (film-coated tablets)
- •o 4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
- •Adjunctive therapy (film-coated tablets & oral suspension)
- •4 years and older Partial-onset seizures: therapy for treatment of partial-onset seizures with or without secondarily generalized seizures in participants with epilepsy
- •7 years and older Primary generalized tonic-clonic seizures: therapy for treatment of primary generalized tonic-clonic seizures in participants with idiopathic generalized epilepsy
- •Participants who have written consent for use of personal and medical information for the study purpose
排除标准
- •Hypersensitivity to the active substance or to any of the excipients of this medicine
- •In case of Fycompa film-coated tablets, Fycompa tablets contains lactose; therefore, participants with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicine. In case of Fycompa oral suspension, Fycompa suspension contains sorbitol; therefore, participants with rare hereditary problems of fructose intolerance should not take this medicine.
- •Other participants judged to be inadequate to participate in the study by doctor
结局指标
主要结局
Number of Participants With Serious Adverse Events
时间窗: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Adverse Drug Reactions
时间窗: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Unexpected Adverse Events
时间窗: From the first Fycompa (Perampanel) administration date up to 24 weeks
Number of Participants With Adverse Events
时间窗: From the first Fycompa (Perampanel) administration date up to 24 weeks
次要结局
- Percentage of Participants With Effective Outcome as Measured by Investigator's Clinical Global Impression of Change (CGI-C) Scores(Up to 24 weeks)