NCT00277602已完成3 期
A Phase III Multicenter, Double-Blind, Parallel-Group, Placebo Controlled Study to Measure the Effect of Riluzole 50 mg b.i.d. Over a Period of Three Years on the Progression of Huntington's Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 537
- 主要终点
- UHDRS-motor score, TFC
研究概览
简要总结
Primary objective:
- The primary objective of the study is to establish that riluzole slows down (1) the decrease in total functional capacity (TFC), (2) the increase of the motor score of the Unified Huntington's Disease Rating Scale (UHDRS) as well as (3) the increase of a combined score of these.
Secondary objectives:
Secondary objectives are to assess
- changes in the other UHDRS subscales
- the number of patients who need antichoreic treatment and the time until this treatment has to be initiated
- the safety/tolerability of riluzole in Huntington patients
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Huntington's disease and CAG repeat length of 36 or more
- •UHDRS Motor score of at least 5 points
- •UHDRS TFC score of at least 8 points, i.e. patients must be independently ambulatory and must not require nursing care
- •Females require a negative blood pregnancy test at inclusion
排除标准
- •Any forms of chorea other than Huntington's disease
- •Patients on antichoreic treatment within one month prior to entry or foreseen to require such treatment within the first 3 months after randomization (antichoreic medication is prohibited during entire study)
- •Other unacceptable prior/concomitant medications
- •Uncontrolled major psychiatric disorders, in particular uncontrolled major depression (DSM IV definition)
- •Drug or alcohol dependence and/or abuse (DSM IV definition) within the past 6 months
- •Any other concomitant disease with a reasonable possibility to interfere with the study
- •Females who are breast-feeding, not sterilized, at least one year postmenopausal or don't use an adequate contraceptive method for at least one month prior to and during study participation
- •Participation in another clinical study with any investigational drug within 30 days prior to study screening
- •Prior exposure to riluzole
- •ALT and/or AST and/or Total Bilirubin levels greater than 1.5 times the upper limits of normal range, or hepatic disease other than Gilbert's disease
- •Creatinine serum concentrations above 200 µmol/l (resp. 2,3 mg/dl) or hematology parameters as follows: Hemoglobin smaller 11 g/dl for males resp. smaller 10 g/dl for females, or White Blood Cell smaller 3,5 x 10000000000/l
结局指标
主要结局
UHDRS-motor score, TFC
次要结局
未报告次要终点
研究者
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