NCT03229031暂停3 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Safety and Efficacy of ES135 in Subjects With Spinal Cord Injury
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
研究概览
简要总结
To demonstrate the superior effect of ES135 combined with spinal cord repairing surgery, compared to a placebo control with spinal cord repairing surgery, on post-surgery motor function recovery as measured by the changes from baseline of ISNCSCI Motor Scores in subjects
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, Investigator, Outcomes Assessor)
盲法说明
Randomized, Double-blind
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of either sex and 15-65 years of age.
- •Subjects have spinal cord injury and the subjects must be categorized as Grade A or B by the ASIA Impairment Scale.
- •Subjects have adequate heart, lung, kidney and liver function.
- •Subjects are able to give voluntary and dated informed consent prior to enrollment.
- •Exclusion Criteria
- •Penetration SCI
- •Brain damage or multiple injuries
- •History of congenital or acquired abnormalities in the spinal cavity
- •History of congenital or acquired immunodeficiency disorders
- •History of malignancies or positive results
- •Current serious/uncontrollable infections or others serious diseases
- •Pregnant or lactating women
- •Allergy to ES135 or any of its excipients
- •Unable to obtain informed consent from subject
排除标准
- 未提供
研究组 & 干预措施
ES135
Experimental
干预措施: ES135 (Drug)
Placebo
Placebo Comparator
干预措施: ES135 (Drug)
结局指标
主要结局
Mean change of International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) Motor Scores
时间窗: 48 weeks
次要结局
未报告次要终点
研究者
研究点 (3)
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