NCT04313166已完成2 期
A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
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
- 55
- 试验地点
- 1
- 主要终点
- Treatment-related changes in disease severity
研究概览
简要总结
Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001
详细描述
Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. [This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001]
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •signed informed consent prior to initiation of any study-specific procedures and treatment
- •documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002
- •Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM
排除标准
- •not dependent on mechanical ventilation
研究组 & 干预措施
Cu(II)ATSM
Experimental
copper-containing synthetic small molecule
干预措施: Cu(II)ATSM (Drug)
结局指标
主要结局
Treatment-related changes in disease severity
时间窗: 24 weeks
Treatment-related changes in disease severity assessed by ALS Functional Rating Scale - Revised (ALSFRS-R)
次要结局
- Treatment-related changed in respiratory function(SVC)
- Treatment-related changes in cognitive function(24 weeks)
- Treatment tolerance(24 weeks)
研究者
研究点 (1)
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