EUCTR2009-017961-52-HU进行中（未招募）不适用
A 12-week, multi-center,randomized, double-blind, placebo-controlled efficacy and safety study examining seizure frequency of BGG492 capsules administration orally three times daily (TID) as adjunctive treatment in patients with partial onset seizures.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Key inclusion criteria:
- •- male or female
- •- weight sup or equal to 50kg
- •- have a diagnosis of epilepsy ( more than 2 years prior to screening) with partial seizures with or without secondarily generalizations seizures
- •- have uncontrolled partial seizures
- •- have at least 4 partial seizures
- •- have no 28-day seizure-free period during the 8 weeks preceding randomization
- •- must be receiving stable treatment with 1 or a maximum of 2 AEDs
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Key exclusion criteria:Any of the following seizure conditions:
- •- Presence of only non-motor simple partial seizures
- •- Pschogenic seizures
- •- Absences and/or myoclonic seizures e.g. in the context of primarily generalized epilepsy
- •- Previous history of Lennox-Gastaut syndrome
- •- Status epilepticus or seizure clusters where individual seizures cannot be counted according to the judgement of the investigator occuring within 52 weeks prior to randomization.
研究者
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