NCT05382767已完成1 期
A Randomized, Double-blind, Active-controlled, Multicenter Phase I Trial to Investigate the Safety and Efficacy of CKDB-501A in Subjects With Post-stroke Upper Limb
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
Multicenter, randomized, double-blind, active-controlled, parallel-design study to evaluate the safety and efficacy of CKDB-501A in Subjects with Post-stroke Upper Limb Spasticity
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 19 years
- •History of stroke more than 24 weeks prior to screening
- •≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of finger flexor and elbow flexor as measured on MAS(0 to 4)
- •≥ 2 points in one of the targeted functional disability item (i.e. hand hygiene, clothing, upper extremity, or pain for evaluation on DAS
排除标准
- •Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
- •Fixed joint/muscle contracture in the target limb
- •History(within 24 weeks of screening visit) or planned(during study period) treatment with phenol or alcohol injection(chemodenervation) or surgery in the target limb
- •History(within 4 months of screening visit) or planned(during study period) treatment with tendon lengthening in the target limb
- •History(within 12 weeks of screening visit) treatment with Botulinum Toxin
- •Concurrent treatment with an intrathecal baclofen
- •Known allergy or sensitivity to the study medication or its components (Clostridium botulinum toxin type A, albumin, Sodium chloride, etc.)
- •Male and Female who are not willing to take any appropriate means of contraception during the study period
- •Patients who are not eligible for this study at the discretion of the investigator.
研究组 & 干预措施
CKDB-501A
Experimental
干预措施: CKDB-501A (Drug)
Botox®
Active Comparator
干预措施: Botox® (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: up to week 12
severity and frequency of reported adverse events
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
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