NCT00784212已完成2 期
A Multicenter, Single-blind, Within-subject, Placebo-controlled Proof of Concept Study to Assess the Effect of Single Oral Doses of BGG492 on the Photoparoxysmal EEG Response in Patients With Photosensitive Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.
研究概览
简要总结
This study will evaluate the efficacy of BGG492 in reducing the sensitivity to flashing lights of patients with photosensitive epilepsy, using EEG as a readout.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of photosensitive epilepsy
排除标准
- •inconsistent photoparoxysmal response when stimulated by photic stimulation
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Cohort 1
Experimental
干预措施: BGG492 (Drug)
Cohort II
Experimental
干预措施: BGG492 (Drug)
Cohort III
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Outcome Measure: Photoparoxysmal response (PPR) and standardized photoparoxysmal response (SPR) determined by EEG on all treatment days.
时间窗: Days 1, 2 and 3
次要结局
- Outcome Measure: Safety and tolerability of BGG492 in patients with photosensitive epilepsy(From Day 1 until Day 33 after treatment start.)
研究者
研究点 (1)
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