NCT01623622已完成2 期
A Phase 2 Study of HC-58 in Patients With Severe Upper Limb Hemiplegia After Stroke
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
- 270
- 主要终点
- Onset of shoulder hand syndrome
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of HC-58 in patients with severe upper limb hemiplegia following stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with severe upper limb hemiplegia after stroke
- •Within 28 days after stroke at enrollment
排除标准
- •Patients with sensory loss between shoulder and hand on paralyzed side
- •Patients with pain between shoulder and hand on paralysed side which affects medical rehabilitation
研究组 & 干预措施
HC-58 low dose
Experimental
Low dose
干预措施: HC-58 (Drug)
HC-58 high dose
Experimental
High dose
干预措施: HC-58 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Onset of shoulder hand syndrome
时间窗: 12 weeks
The incidence rate of shoulder hand syndrome
Change from Baseline in the modified Barthel index (MBI) and MBI efficiency
时间窗: 12 weeks
MBI efficiency means MBI gain divided by period of administration
Change from Baseline in the Fugl-Meyer Assessment (FMA) (upper limb) and FMA efficiency
时间窗: 12 weeks
FMA efficiency means FMA gain divided by period of administration
次要结局
- Swelling asymmetry between hands(12 weeks)
- Discolouration of the skin of the hand(12 weeks)
- Bone metabolic marker(12 weeks)
- Pain score by numeric rating scale(12 weeks)
- Difference in skin temperature between hands(12 weeks)
- Decreased range of motion(12 weeks)
- Radiographic finding of bone(12 weeks)
研究者
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