NCT01384435已完成2 期
A Randomized, Double Blind, Placebo-controlled Phase II 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
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in Scale for the assessment and rating of ataxia (SARA)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KPS-0373 compared to placebo in patients with Spinocerebellar Degeneration (SCD).
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
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
KPS-0373, lowest dose
Experimental
干预措施: KPS-0373 (Drug)
KPS-0373, 2nd lowest dose
Experimental
干预措施: KPS-0373 (Drug)
KPS-0373, 2nd highest dose
Experimental
干预措施: KPS-0373 (Drug)
KPS-0373, highest dose
Experimental
干预措施: KPS-0373 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in Scale for the assessment and rating of ataxia (SARA)
时间窗: 24 weeks
次要结局
- Change from baseline in patient improvement impression of activities of daily living(24 weeks)
研究者
研究点 (1)
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