NCT03289702已完成3 期
A Randomized, Double-blind, Active Drug Controlled, Multi-Center, Phase I/III Clinical Trial to Evaluate the Efficacy and Safety of CORETOX® in Treatment of Post Stroke Upper Limb Spasticity
Medy-Tox1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2017年11月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- MAS(Modified Ashworth Scale)of wrist flexor
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of CORETOX® in the treatment of 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •≥ 6 months since the last stroke
- •≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 point at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
- •Informed consent has been obtained
排除标准
- •Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
- •History(within 4 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection 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
- •Fixed joint/muscle contracture
- •Severe atrophy
- •Concurrent treatment with an intrathecal baclofen
- •Patients who have bleeding tendency or taking anti-coagulant
- •Dysphagia and Breathing Difficulties
- •History(within 4 months of screening visit) Planned(during study period) treatment with Botulinum Toxin
- •Known allergy or sensitivity to study medication or its components
- •Concurrent or planed Muscle relaxants and/or benzodiazepine medication If patient has taken these medication stable from one month before screening and no treatment changes are not planned during the study, participation is allowed.
- •Current Physical, occupational, Splinting therapy These therapy regimens will be permitted if they have been stable in the one month before screening; no treatment and no changes are planned during the study.
- •Patient who are participating in other clinical trials at the screening
- •Females who are pregnant, breastfeeding, or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of contraception.
- •Patients who are not eligible for this study at the discretion of the investigator.
研究组 & 干预措施
CORETOX®
Experimental
干预措施: CORETOX® (Drug)
BOTOX®
Active Comparator
干预措施: BOTOX® (Drug)
结局指标
主要结局
MAS(Modified Ashworth Scale)of wrist flexor
时间窗: 4 weeks
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale)
次要结局
- MAS(modified Ashworth Score)of elbow and finger flexor(4 weeks after injection)
- Percentage of treatment responder at week 4, 8, 12 after injection(4, 8, 12 weeks after injection)
- MAS(modified Ashworth Score)of wrist, elbow and finger flexor(8, 12 weeks after injection)
研究者
研究点 (1)
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