NCT00401648已完成2 期
A Placebo-controlled, Single-blind, Multi-center Study to Explore the Photoparoxysmal Response in Photosensitive Epileptic Subjects After One Single Oral Dose of Brivaracetam in Capsules.
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
研究概览
简要总结
to assess the effect of brivaracetam on the photoparoxysmal EEG response in photosensitive epileptic subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •epileptic subjects with generalized PPR
排除标准
- •more than 2 concomitant antiepileptic drugs
结局指标
主要结局
Identify lowest single oral dose producing maximal decrease or suppression of intermittent photic stimulation (IPS)photoparoxysmal response (PPR) in photosensitive epileptic subjects pre-dose
post placebo during 24h and post brivaracetam for up to 72 h
次要结局
- Assess relationship between plasma concentrations and changes in photosensitivity frequency range, time of onset and duration of suppressing effect
- Safety
研究者
研究点 (5)
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