NCT01825551已完成2 期
The Effect of Granulocyte Colony Stimulating Factor (GCSF) in the Treatment of Amyotrophic Lateral Sclerosis (ALS) Patients Referred to Tehran Imam Khomeini and Shariati Hospital Centers in 2013
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- patient's function
研究概览
简要总结
The aim of this study is to evaluate the effect off Granulocyte Colony Stimulating Factor (GCSF) in the treatment of Amyotrophic Lateral Sclerosis (ALS) 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 85
- •definite or probable ALS according to revised El Escorial criteria
- •maximum 2 years from initiation of symptoms to study entry
- •mild to moderate disability according to revised ALS functional rating scale (ALSFRS-r)
排除标准
- •familial ALS
- •pregnancy or lactation
- •myeloproliferative or hematologic disorders
- •active immunological disease
- •liver or renal or heart disease
- •HIV positive
- •significant cognitive disorder
- •hypersensitivity to GCSF
研究组 & 干预措施
Granulocyte Colony Stimulating Factor
Active Comparator
Granulocyte Colony Stimulating Factor 10 microgram/ kg/ day for 5 days subcutaneously
干预措施: Granulocyte Colony Stimulating Factor (Drug)
Placebo
Placebo Comparator
normal saline 0.01 ml/kg/day for 5 days subcutaneously
干预措施: Placebo (Drug)
结局指标
主要结局
patient's function
时间窗: one year
based on revised ALS Functional Rating scale (ALSFRS-r)
次要结局
- muscle power(1 year)
- mobilizing bone marrow stem cells(1 year)
- amplitude of compound muscle action potential in ulnar and peroneal nerve(1 year)
- quality of life(1 year)
研究者
研究点 (1)
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