NCT01970111已完成3 期
An Extension 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
- 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 evaluate the long-term safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients.
研究设计
- 研究类型
- Interventional
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 (Completion of the KPS1301 study)
排除标准
- •Less than 75% of compliance in KPS1301 study
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)
结局指标
主要结局
SARA (Scale for the Assessment and Rating of Ataxia)
时间窗: 52 weeks
次要结局
- SF-8 (QOL)(52 weeks)
研究者
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