NCT01019473终止2 期
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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score.
研究概览
简要总结
This study will assess the efficacy, safety and tolerability of AFQ056 when added to optimize standard therapy in patients that have Huntington's disease in reducing chorea.
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
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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
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 inclusion/exclusion criteria may apply
研究组 & 干预措施
AFQ056A
Experimental
干预措施: AFQ056 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy of AFQ056 on the severity of chorea in Huntington's disease measured by Unified Huntington's Disease Rating Scale (UHDRS) Maximal Chorea score.
时间窗: Baseline to day 28
次要结局
- Potential effect of AFQ056 on the motor, cognitive, behavioral and functional assessments using UHDRS.(Day 1 to day 46)
- Potential effect of AFQ056 on functional and quality of life scales, neuropsychiatric assessments and cognitive assessments in Huntington's Disease patients(Day 1 to day 46)
研究者
研究点 (1)
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