NCT01970098已完成3 期
A Phase III Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 374
- 主要终点
- SARA (Scale for the Assessment and Rating of Ataxia)
研究概览
简要总结
The purpose of this study is to investigate the superiority of KPS-0373 to placebo, and evaluate the safety and pharmacokinetics of KPS-0373 in SCD patients.
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
- 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
Experimental
干预措施: KPS-0373, High dose (Drug)
KPS-0373
Experimental
干预措施: KPS-0373, Low dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
SARA (Scale for the Assessment and Rating of Ataxia)
时间窗: 24 weeks
The change in the SARA total score at the time of final evaluation
次要结局
- SF-8 (QOL)(24 weeks)
研究者
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