EUCTR2006-002813-11-BE进行中（未招募）1 期
A phase II randomised, double blind, placebo-controlled, dose finding, safety and tolerability trial of XY2405 as a treatment for traumatic brain injury - BRAIN trial
Xytis Pharmaceuticals Sàrl0 个研究点目标入组 400 人开始时间: 2006年12月4日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 400
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
- •Patient must fulfil the following criteria to be eligible for enrolment in this study:
- •- Admitted to hospital with traumatic brain injury
- •- Age: Legally adult, between 16 and 65 years, inclusive
- •- Gender: male or non-pregnant female (no childbearing potential, or negative pregnancy test)
- •- Head trauma within 8 hours to initiation of treatment with study drug
- •- Glasgow Coma Scale Score of 12 or less
- •- CT scan showing intracranial abnormality consistent with trauma
- •- Consented in accordance with local legal requirements
- •- Potential to benefit i.e. there is some prospect of survival
- •Are the trial subjects under 18? yes
- •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
- •Known treatment with another investigational drug therapy within 30 days of injury
研究者
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