NCT01438684暂停1 期
Phase 1 Study of RPh201 in Patients With Chronic Vegetative or Minimal Conscious State
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- consciousness level measured clinically
研究概览
简要总结
The aim is to evaluate the impact of RPh201 on brain activity in chronic vegetative state patients. The assessment will be done using clinical measurements and functional MRI studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic vegetative state patients
排除标准
- •allergic reaction to treatment
- •patients that can not undergo MRI
- •Pregnancy
研究组 & 干预措施
RPh201 group
Active Comparator
7 patients will receive the treatment
干预措施: RPh201 (Drug)
non RPh201 group
Placebo Comparator
3 patients will receive placebo
干预措施: Saline (Drug)
结局指标
主要结局
consciousness level measured clinically
时间窗: 6 months
Each patient will undergo a behavioral assessment (using the Coma Recovery Scale Revised) before treatment and every 2 weeks during the treatment period as well as 3 months following the end of the treatment. Complete blood counts, electrolytes, liver function tests, renal function tests and ECG will be performed every two weeks.
次要结局
- Functional magnetic resonance imaging of cortical activity(6 months)
研究者
研究点 (1)
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