NCT00387270已完成1 期
A Multicenter, Phase 1-2A, Open-Label, Dosage-Escalation and Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Dose-limiting toxicities
研究概览
简要总结
This study is being conducted to determine the safety and tolerability of Dimebon in people with Huntington's disease after short-term exposure (one week) and after longer exposure (three months). Also, the study will assess whether or not there is an effect of Dimebon on the symptoms of Huntington's disease, including cognitive (thinking abilities), motor (movement), behavior, and overall functioning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical features of Huntington's disease and a confirmatory family history of HD, or a CAG repeat expansion greater than or equal to 36
- •Stage I,II,III HD and a total functional capacity greater than or equal to 5 on the Unified Huntington's Disease Rating Scale
排除标准
- •Clinical evidence of unstable medical illness
研究组 & 干预措施
A
Experimental
Dimebon
干预措施: Dimebon (Drug)
结局指标
主要结局
Dose-limiting toxicities
时间窗: 7 days
次要结局
- Unified Huntington's Disease Rating Scale(7 days)
研究者
研究点 (1)
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