JPRN-jRCT2080223559已完成3 期
A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalization
CB Japan Co., Ltd.0 个研究点目标入组 444 人开始时间: 2017年6月15日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 444
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 16age old 至 <= 80age old（—）
- 性别
- All
入选标准
- •Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
- •- Presence of an electroencephalogram (EEG) reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
- •- Presence of a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan performed within the last 2 years
- •- Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
- •- Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
- •- Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
- •- Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) before Visit 1 and expected to be kept stable during whole study period
排除标准
- •- Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
- •- Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 24 weeks
- •- Subject has history or presence of known psychogenic nonepileptic seizures
研究者
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