An International, Double-blind, Randomized, Multi-center, Parallel Group, Historical-control Conversion to Monotherapy Study to Evaluate the Efficacy and Safety of Brivaracetam in Subjects (≥ 16 to 75 Years Old) With Partial Onset Seizures With or Without Secondary Generalization
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 88
- 主要终点
- The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
研究概览
简要总结
Antiepileptic drugs (AEDs) are the main treatment for epilepsy; however, only a limited number of AEDs are approved for use as monotherapy. The objective of this study is to evaluate the efficacy of Brivaracetam (BRV) in the conversion of partial onset seizure patients from combination treatment to monotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects from 16 to 75 years, both inclusive
- •Well-characterized focal epilepsy or epileptic syndrome
- •Subjects having at least 2 but not exceeding 40 partial onset seizures, whether or not secondarily generalized per 4 weeks during the 8-week Baseline Period
- •Subjects on a stable dose of at least 1 but no more than 2 concomitant Antiepileptic Drugs (AEDs) with the second AED ≤ 50 % of the minimum recommended maintenance dose
排除标准
- •Seizure type IA non-motor as only seizure type
- •History or presence of seizures occurring too frequently or indistinctly separated to be reliably counted during the 6 months preceding Visit 1 or during Baseline
- •Other serious uncontrolled disease
研究组 & 干预措施
Brivaracetam 50 mg
50 mg/day
干预措施: Brivaracetam (Drug)
Brivaracetam 100 mg
100 mg/day
干预措施: Brivaracetam (Drug)
结局指标
主要结局
The Cumulative Exit Rate at 112 Days After the Beginning of the Baseline Antiepileptic Drug (AED) Tapering Phase
时间窗: From Week 1 up to Week 17
The cumulative exit rate was estimated using Kaplan-Meier methods and was based on the duration between start of the Evaluation Period (EP) and the earliest date the first exit criterion was met for each subject. Subjects completing the EP without meeting an exit criterion were censored on Day 112. The primary comparison was BRV 50 mg/day vs a historical control. The upper limit of the 2-sided 95 % Confidence Interval for the estimate was compared to the historical lower bound estimate of 0.722.
次要结局
- The Number of Patient Withdrawal Due to Adverse Events (AEs) During the Course of the Study(Baseline through Re-conversion (approximately 31 weeks))
- The Number of Patients Reporting at Least One Treatment-Emergent Adverse Event (TEAE) During the Course of the Study(Baseline through Re-conversion (approximately 31 weeks))
- The Number of Patients Reporting at Least One Serious Adverse Event (SAE) During the Course of the Study(Baseline through Re-conversion (approximately 31 weeks))