An Open label, Multicentre, Follow up study to evaluate the long term safety and efficacy of Brivaracetam used as adjunctive treatment in subject aged 16 years or older with Epilepsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 6
- 主要终点
- The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28-day
研究概览
简要总结
UCB is developing BRV(Brivaracetam) as an adjunctive antiepileptic treatment in subjects 16 years and older suffering from focal epilepsy. N01379 will give subjects who have completed N01358 the opportunity to access BRV (Brivaracetam) under the present protocol. N01358 is an adequate and well-controlled study to provide additional data confirming the efficacy and safety of BRV (Brivaracetam) as an AED (Anti Epiletic Drug) in adults (more than or equal to16 years) with refractory POS whether or not secondarily generalized. N01379 will explore the long-term safety and efficacy of BRV (Brivaracetam) in subjects with POS (Partial Onset Seizures) whether or not secondarily generalized while providing access to BRV (Brivaracetam) for subjects who may benefit from open-label treatment with BRV (Brivaracetam) .
Study is globally in recruitment. In India recruitment has started.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 16.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Subject completed the Treatment Period of N
- •Subject for whom the Investigator believes a reasonable benefit from the long term administration of BRV may be expected.
排除标准
- •Subject has developed hypersensitivity to any components of the investigational medicinal product (IMP) or comparative drugs as stated in this protocol during the course of the core study Severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject Poor compliance with the visit schedule or medication intake in the previous BRV study Any medical condition which, in the Investigator?s opinion, warrants exclusion.
结局指标
主要结局
The primary efficacy variable is the POS (type I) seizure frequency standardized to a 28-day
时间窗: This will be summarized by 3-month periods over the Evaluation Period.
duration.
时间窗: This will be summarized by 3-month periods over the Evaluation Period.
次要结局
- The secondary objective is to evaluate the maintenance of efficacy of(BRV over time.)