EUCTR2009-011743-39-DE进行中（未招募）不适用
A multi-centre, randomized, double-blind, placebo-controlled, parallel-group, multiple oral dose titration Proof of Concept study in patients with Huntington's disease to assess the efficacy, safety and tolerability of AFQ056 in reducing chorea
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Huntington's disease (based on DNA testing polyQ >36) with a UHDRS maximal chorea score of >10
- •- patient with concomitant Huntington's medication (anti-depressants, neuroleptics, benzodiazepines) are allowed but the total daily dose and dosing regimen has to be stable for at least one months prior to randomization
- •- female patients without childbearing potential (post-menopausal or surgically sterilized), all patients must using a double-barrier local contraception
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- patients with marked cognitive impairment (MMSE less than 18), with presence of psychosis and/or confusional states
- •- patients with a history or presence of renal impairment and/or liver disease
- •Other protocol-defined exclusion criteria may apply
研究者
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