EUCTR2004-000394-60-SE进行中（未招募）不适用
A randomised phase II multicentre, double blind, parallel group, placebo controlled study of ACR16 50 mg once daily for the symptomatic treatment of Huntington disease
A. Carlsson Research AB0 个研究点目标入组 60 人开始时间: 2004年5月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 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 disease diagnosed with the aid of clinical features and the presence of > 35 CAG repeats in the Huntington gene.
- •Ambulatory and willing and able to comply with the study specific procedures.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Second or third degree AV block or sick sinus syndrome; resting heart rate below 50 beats per minute; congestive heart failure classified as functional Class III or IV by the New York Heart Association; myocardial infarction within six months of baseline; a prolonged QTc interval at screen or pre-treatment (defined as a QTc interval of > 450 msec for males or > 470 msec for females); other clinically significant heart conditions which would negatively impact on the patient completing the study.
- •Serum creatinine concentrations above 200 mmol/l.
- •Any other clinically significant condition or laboratory assay abnormality that would interfere with the patient’s ability to participate in the study.
- •Female of childbearing potential.
- •Antichoreic medication, with exception of Risperidon, within 30 days before inclusion. If Risperidon has been taken the dose should have been kept stable for 30 days before inclusion and should remain stable throughout the study.
研究者
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