NCT00230074已完成2 期
A Long-term Extension Study of TCH346 and Placebo Administered Once Daily in Patients With Amyotrophic Lateral Sclerosis(ALS)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 350
- 试验地点
- 2
- 主要终点
- Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
研究概览
简要总结
This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.
详细描述
This is a study to evaluate the safety and clinical effects of 4 oral doses of TCH346 compared to placebo in patients with mild or mild to moderate stages of ALS.
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
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed original protocol, Study No. CTCH346A2211
- •Be capable of satisfying the requirements of the extension protocol and must sign informed consent after the nature of the extension protocol has been fully explained
排除标准
- •Exclusion criteria as described in the original protocol will remain applicable into the extension protocol
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Rate of functional decline as defined by the ALS Functional Rating Scale-Revised
次要结局
- Survival time
- Functional outcome measures including pulmonary function and manual muscle strength assessments (every visit)
研究者
研究点 (2)
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