A Prospective, Non-Interventional, Observational, Multicenter Study to Investigate Dosage, Effectiveness, and Safety of Perampanel When Used as First Adjunctive Therapy in the Routine Clinical Care of Subjects >=12 Years With Partial Onset Seizures With or Without Secondary Generalization or With Primary Generalized Tonic-Clonic Seizures Associated With Idiopathic Generalized Epilepsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 191
- 试验地点
- 36
- 主要终点
- Retention Rate at Month 12
研究概览
简要总结
The primary purpose of this study is to assess the retention rate of perampanel as a reliable proxy for overall effectiveness and tolerability in participants aged at least 12 years who are prescribed perampanel (for partial onset seizures [POS] with or without secondary generalization [SG] or for primary generalized tonic-clonic seizures [PGTCS] associated with idiopathic generalized epilepsy [IGE] as first adjunctive to antiepileptic drug (AED) monotherapy as part of their routine clinical care.
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 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of epilepsy
- •History of POS with or without SG or PGTCS associated with IGE
- •Documented POS with or without SG or PGTCS associated with IGE, within the past 12 months
- •Previously treated with 1 or 2 AEDs as monotherapy
- •At least 4 weeks' seizure diary data, or sufficient clinical detail to calculate baseline seizure frequency
排除标准
- •Episode(s) of status epilepticus within the past 6 months before Screening
- •Previously treated with 2 or more AEDs in combination (other than during cross-titration between AED monotherapies)
- •Previous or current use of perampanel
- •Note: Retrospective inclusions will be allowed but only if the time between the initiation of perampanel treatment and the inclusion does not exceed 7 calendar days
- •Hypersensitivity to perampanel or any of the excipients
研究组 & 干预措施
Perampanel
Participants with a diagnosis of epilepsy (POS with or without SG or PGTCS associated with IGE) will initiate treatment with perampanel as first adjunctive treatment as per the clinical judgment of the treating physician as part of routine clinical care. All participants will be observed prospectively for up to 12 months after initiation of perampanel treatment.
干预措施: Perampanel (Drug)
结局指标
主要结局
Retention Rate at Month 12
时间窗: Month 12
Retention rate at 12 months is defined as the percentage of participants remaining on perampanel at 12 months.
次要结局
- Retention Rate at Month 6(Month 6)
- Pragmatic Seizure-free Rate at Months 6 and 12(Months 6 and 12)
- Completer Seizure-free Rate at Months 6 and 12(Months 6 and 12)
- Median Percent Change From Baseline in Seizure Frequency at Months 6 and 12(Months 6 and 12)
- 50 Percent (%) Responder Rate at Months 6 and 12(Months 6 and 12)
- Seizure Worsening Rate at Months 6 and 12(Months 6 and 12)
- Last Dose of Perampanel at Months 6 and 12(Months 6 and 12)
- Percentage of Participants by Perampanel Dose Titration Speed(Up to Month 12)
- Duration of Treatment on Perampanel(Up to Month 12)
- Percentage of Participants Reporting one or More Treatment-emergent Adverse Events (TEAEs),Serious Adverse Events (SAEs), TEAEs Leading to Discontinuation, and TEAEs by Severity(Up to Month 12)