NCT00600873已完成1 期
Pharmacokinetics and Nitrative-Oxidative Stress Pharmacodynamics in Amyotrophic Lateral Sclerosis Subjects Taking Daily High-Dose R(+) Pramipexole Dihydrochloride for Six Months
Bennett, James P., Jr., M.D., Ph.D.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2007年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- decline in ALSFRS score
研究概览
简要总结
R(+)pramipexole is administered in escalating doses to patients with early ALS. Plasma and spinal fluid levels of R(+)PPX are monitored, in addition to biochemical markers of oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •definite ALS no prior exposure to R(+)PPX
排除标准
- •ALSFRS at baseline <40 FVC at baseline <70%
研究组 & 干预措施
1
Experimental
patients with early ALS
干预措施: R(+) pramipexole dihydrochloride monohydrate (Drug)
结局指标
主要结局
decline in ALSFRS score
时间窗: 6 months
次要结局
- plasma PPX levels(6 months)
- CSF PPX levels(6 months)
研究者
研究点 (1)
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