NCT00542412已完成4 期
Care (Canadian ALS Riluzole Evaluation) Multicentre Phase IV Comparative Study of the Effects of Riluzole 50mg Bid on the Survival of ALS Subjects Compared to Historical Controls
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)
研究概览
简要总结
Evaluate the efficacy of riluzole 50-mg bid defined by comparing the percentage of riluzole-treated subjects who experienced death, permanently assisted ventilation (PAV) or tracheostomy, to a group of recent historical controls for the treatment of amyotrophic lateral sclerosis (ALS).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of ALS confirmed by the following definition:
- •(a)"Probable" or "Definite" Amyotrophic Lateral Sclerosis (ALS) according to the El Escorial criteria(b)"Peripheral" onset form (limb involvement) or a "Bulbar" form of ALS with a duration of five years, based on inquiry for the earliest symptoms of the disease
- •A subject who simultaneously presents with bulbar and peripheral signs at onset of ALS disease should be stratified to the bulbar onset group. The neurologic progression of such subjects matches that of the bulbar onset ALS subjects.
- •Pulmonary Function: forced vital capacity (FVC) must be 3 60% at study entry.
- •Females of childbearing potential must be documented to be using acceptable birth control methods such as an IUD or oral contraceptives.
排除标准
- •Previous treatment with riluzole
- •Tracheostomy, or expected to undergo a tracheostomy within two months after study inclusion
- •Signs of clinical dementia and/or major psychiatric disorders
- •Serious concomitant disease or handicap likely to interfere with the subject's assessments or impact on the subject's survival
- •A multiple conduction block has been shown on nerve conduction studies by electromyogram
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
The primary efficacy endpoint was the time to the occurrence of an ALS-related event (PAV, tracheostomy or ALS-related death)
次要结局
未报告次要终点
研究者
研究点 (1)
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