NCT00497159已完成2 期
A Multi-Center, Phase 2 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
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
研究概览
简要总结
This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 29 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
- •Able to take medication (capsules) by mouth.
排除标准
- •Clinical evidence of unstable medical illness;
- •Females who are pregnant or lactating or who intend to become pregnant during the study period.
研究组 & 干预措施
1
Placebo Comparator
Placebo
干预措施: Placebo (Other)
2
Experimental
Dimebon
干预措施: Dimebon (Drug)
结局指标
主要结局
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
时间窗: 90 days
次要结局
- To assess the pharmacokinetics of Dimebon.(90 days)
- To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.(90 days)
研究者
研究点 (1)
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