NCT00140452已完成2 期
Phase II Study Using Thalidomide for the Treatment of Amyotrophic Lateral Sclerosis
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS
研究概览
简要总结
The use of Thalidomide in patients with ALS who have disease progression.
详细描述
Phase II open labeled trial testing the efficacy of thalidomide for ALS in the setting of disease progression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically proven ALS
- •Disease duration less than or equal to 5 years
- •ALSFRS-R score equal to or greater then 30
排除标准
- •Patients with known deep venous thrombosis or hyper coagulable state will be excluded
- •Patients with FVC less than 80%
结局指标
主要结局
To evaluate the effect of Thalidomide in the rate of progression in ALS at 9 months and hence determine preliminary efficacy in the treatment of ALS
时间窗: Efficacy will be gauged according to the slopeof the expected average decline at nine months after starting Thalidomide
次要结局
- To evaluate 1) toxicity 2) quality of life 3) cytokine profile 4) PFT's 5) sleep questionnaire and 6) survival of thalidomide in the treatment of ALS(survival and progression free suvival will be assessed from the date of initial therapy on study to date od death. Survival and progresion free survival wil be analyzed using the Kaplan Meier method)
研究者
研究点 (1)
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