EUCTR2010-021448-17-HU进行中（未招募）不适用
A multicenter, open-label, follow-up study to evaluate the long-term safety and tolerability of BGG492 TID as adjunctive therapy in patients with partial onset seizures completing double-blind, placebo-controlled study CBGG492A2207 or CBGG492A2211. - not available
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
- •- Have completed 10 week double-blind treatment evaluation Phase plus one week of dose-tapering in study 2207 or 2211, have cooperated in study procedures and have been perceived by investigator as deriving benefit from taking the study medication without experiencing tolerability issues.
- •- patients who wish to continue BGG492 treatment
- •- male and female outpatients age 18 to 66 Years (inclusive)
- •- weight sup or equal to 45kg
- •- are currently treated with a stable dose of 1 or max 2 licensed AEDs
- •- are reliable
- •- have provided written informed consent
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- history of status epilepticus or seizure clusters occuring during study 2207 or 2211
- •- patients with a planned brain surgery in the next 6 months
- •- no physical examination changes suggestive of progressive neurological changes (AD, PD, MS)
- •- patients who received prohibited medication or used benzodiazepines intermittently during the double-blind studies
- •- history of hypersensitivity to study drug or to drugs of similar chemical classes
研究者
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