NCT01281631已完成2 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of NP001 in Subjects With Amyotrophic Lateral Sclerosis (ALS)
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
- 136
- 试验地点
- 17
- 主要终点
- To evaluate the effects of NP001 on measures of clinical function
研究概览
简要总结
This is a Phase 2 randomized, double-blind, placebo-controlled, multicenter study of NP001 in subjects with ALS.
详细描述
This is a randomized, double-blind, placebo-controlled study of NP001 in subjects with ALS conducted in multiple centers. Drug or placebo will be given intravenously. Approximately 105 subjects will be enrolled. Subjects will be allocated (1:1:1) to placebo and 2 dose levels of NP001.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Onset of symptoms less than 3 years prior to study entry.
- •Forced Vital Capacity (FVC) at least 70% of that predicted for age and height.
- •Stable dose of riluzole if undergoing treatment with this agent.
- •For females: Not be of childbearing potential or agree to use adequate birth control during the study.
排除标准
- •Unstable medical condition(s) other than ALS.
- •Life expectancy of less than 6 months.
- •Require life-sustaining interventions for the 6 months following randomization.
- •Have a tracheotomy or be using ventilatory assistance [including Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP)].
- •Active pulmonary disease.
- •Immune modulator therapy within 12 weeks of study entry or participation in studies of other agents within the last 4 weeks prior to the randomization.
研究组 & 干预措施
Low dose NP001
Experimental
Low drug dose
干预措施: NP001 (Drug)
High dose NP001
Experimental
High drug dose
干预措施: NP001 (Drug)
Placebo
Placebo Comparator
normal saline
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the effects of NP001 on measures of clinical function
时间窗: over 9 months
次要结局
- Pulmonary function and biomarkers(over 9 months)
- Safety and tolerability in ALS(duration of study)
研究者
研究点 (17)
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