Multicenter, Open-label Trial Evaluating the Efficacy and Safety of Perampanel Added to Monotherapy in Patients With Partial Onset Seizures With or Without Secondary Generalization
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- 50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
研究概览
简要总结
This is a multi-center, open-label, single-arm, phase 4 study to evaluate the efficacy of perampanel added to monotherapy for partial onset seizures with or without secondarily generalized seizures (total seizures).
详细描述
This multi-center, open-label, single-arm study evaluating the efficacy of perampanel added to monotherapy for partial onset seizures consists of 2 periods: Titration Period (12 weeks) and Maintenance Period (24 weeks). During the Titration Period, participants will begin receiving perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Have a diagnosis of epilepsy with partial onset seizures with or without secondarily generalized seizures according to the International League Against Epilepsy's Classification of Epileptic Seizures (1981)
- •Need an initial add-on therapy after failure to control seizures with the first or further monotherapy at the optimal dose and duration
- •Despite antiepileptic drug (AED) treatment within the last 8 weeks, participants must have had greater than or equal to 2 partial onset seizures, and the interval between those seizures should be more than 24 hours prior to Visit 1 (Week 0).
- •Are currently being treated with stable doses of monotherapy for 8 weeks prior to Visit 1 (Week 0) (Standard AEDs)
- •If antidepressants or antianxiety drugs are used, participants must be receiving stable doses and administrations of antidepressants or antianxiety drugs for 8 weeks prior to Visit 1 (Week 0)
排除标准
- •Females who are pregnant (positive beta-human chorionic gonadotropin (β-hCG test) or breastfeeding
- •Presence of previous history of Lennox-Gastaut syndrome
- •Presence of nonmotor simple partial seizures only
- •Presence of primary generalized epilepsies or seizures such as absences and/or myoclonic epilepsies
- •A history of status epilepticus within 12 weeks before Visit 1 (Week 0)
- •Participants on antipsychotics or who have psychotic disorder(s) or unstable recurrent affective disorder(s) with a history of attempted suicide within 1 year before Visit 1 (Week 0)
- •Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors
- •Concomitant use of barbiturates (except for seizure control indication and premedication for electroencephalogram [EEG]) and benzodiazepines (except for seizure control indication) within 8 weeks prior to Visit 1 (Week 0)
- •Use of intermittent rescue benzodiazepines (that is, 1 to 2 doses over a 24-hr period considered one-time rescue) 2 or more times in an 8-week period prior to Visit 1 (Week 0)
- •Participant who is participating in other intervention clinical trial
研究组 & 干预措施
Perampanel 12 mg
During the Titration Period, participants will receive perampanel 2 milligrams per day (mg/day) and be up-titrated in no less than 2-week intervals in increments of 2 mg up to 12 mg according to the investigator's judgment. Upon entering the Maintenance Period, participants will receive the last dose they achieved at the end of the Titration Period and will continue receiving this dose once daily for the remainder of the study.
干预措施: Perampanel (Drug)
结局指标
主要结局
50 Percent (%) Responder Rate for Partial Onset Seizure With or Without Secondary Generalization
时间窗: Baseline up to Week 36
The 50% responder rate was defined as the percentage of participants who achieved at least 50% reduction from baseline in the frequency of partial onset seizure with or without secondary generalization during the Maintenance Period.
次要结局
- 100% Responder Rate (Seizure Free Rate) for Partial Onset Seizure With or Without Secondary Generalization(Baseline up to Week 36)
- 50% Responder Rate in Secondary Generalized Tonic Clonic (GTC) Seizures(Baseline up to Week 36)
- 75% Responder Rate for Partial Onset Seizure With or Without Secondary Generalization(Baseline up to Week 36)
- 75% Responder Rate in Secondary GTC Seizures(Baseline up to Week 36)
- Percent Change From Baseline in Secondary GTC Seizure Frequency to the Titration and Maintenance Period(Weeks 12 and 36)
- Percent Change From Baseline in Partial Onset Seizure Frequency With or Without Secondary Generalization to the Titration and Maintenance Period(Weeks 12 and 36)
- 100% Responder Rate (Seizure Free Rate) in Secondary GTC Seizures(Baseline up to Week 36)
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(From the first dose of investigational product to the last visit or 28 days after the last dose (up to 1 year 11 months))