NCT01970137已完成3 期
A 24-week Open-label 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 safety, efficacy, and pharmacokinetics of KPS-0373 in SCD patients (Experience of clinical trials of KPS-0373)
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 ataxia (Experience of clinical trials of KPS-0373)
排除标准
- •Patients with secondary ataxia
- •Patients with clinically significant hepatic, renal, or cardiovascular dysfunction
- •Discontinuations in another clinical trials caused by side effects
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: 24 weeks
次要结局
- SF-8 (QOL)(24 weeks)
研究者
相似试验
已完成
3 期
An Extension Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)Spinocerebellar DegenerationNCT01970111Kissei Pharmaceutical Co., Ltd.
已完成
2 期
Phase II Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)Spinocerebellar DegenerationNCT00863538Kissei Pharmaceutical Co., Ltd.40
已完成
3 期
A Long-Term Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)Spinocerebellar DegenerationNCT01970124Kissei Pharmaceutical Co., Ltd.
已完成
3 期
A Confirmatory Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)Spinocerebellar DegenerationNCT01970098Kissei Pharmaceutical Co., Ltd.374
已完成
2 期
A Phase II Double Blind Comparative Study of KPS-0373 in Patients With Spinocerebellar Degeneration (SCD)SCDNCT01384435Kissei Pharmaceutical Co., Ltd.200