NCT01004016已完成2 期
A Double-blind, Placebo-controlled, Crossover Study, Followed by Open-label Study of KPS-0373 in Patients With SCD
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
- 20
- 试验地点
- 1
- 主要终点
- Scale for Assessment and Rating of Ataxia (SARA)
研究概览
简要总结
To evaluate the efficacy and safety of KPS-0373 in patients with SCD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese SCD patients with mild to moderate ataxia
排除标准
- •Patients with secondary ataxia
- •Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
KPS-0373
Experimental
干预措施: KPS-0373 (Drug)
结局指标
主要结局
Scale for Assessment and Rating of Ataxia (SARA)
时间窗: 4 weeks + 12 weeks
Upper and lower extremity function
时间窗: 4 weeks + 12 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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