NCT05289921已完成3 期
Multi Center, Phase III Clinical Trial to Evaluate the Safety and Efficacy of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 1
- 主要终点
- MAS score improvement at Wrist Flexor
研究概览
简要总结
Investigational Product: LIZTOX inj 100unit(HU-014) Title : Multi Center, Phase III Clinical Trial to Evaluate the efficacy and Safety of LIZTOX Inj in the Treatment of Post Stroke Upper Limb Spasticity Sites and investigators : Asan Medical Center(Seoul), Min-ho Chun, M.D, Ph.D Objective : To evaluate the efficacy and safety of LIZTOX inj 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject who is diagnosed with Stroke at least six weeks prior to Screening.
- •A subject who has Modified ashworth scale(MAS) score which Wrist Flexor is ≥ 2 and Flexor or Finger Flexor is ≥
- •A subject with a Disability assessment scale(DAS)of at least ≥ 2 in one of the categories of hand hygiene, clothing, upper extremity, or pain for evaluation.
排除标准
- •A subject who has medical history following. (Allergy, Chemodenervation(within 6 months), Tendon lengthening(within 6 months), Intrathecal baclofen.Aspiration pneumonia, etc.)
- •A subject who has history of any diseases following. (neuromuscular junction disorder, NMJ, myasthemia gravis, MG, Lambert-Eaton myasthenic syndrome, amyotrophic lateral sclerosis, ALS, Skin disease, Dysphagia, etc.)
- •From screening, Subject who get a plastic Surgery including fascioplasty, Prosthesis implantation within 6 Weeks
- •Subject who takes a medication including skeletal muscle relaxants, Aminoglycoside, lincomycin, anticholinergic drug, benzodiazepine, benzamide etc.
- •A subject who tend to bleed or are taking anti-coagulant drugs.
- •A sugject who is undergoing rehabilitation(physical therapy, occupational therapy, exercise therapy) or Splinting in the area where medication for clinical trials is scheduled to be administered.
- •A sugject who has muscle atrophy, fixed joint/muscle contracture in the area where medication for clinical trials is scheduled to be administered.
- •Any condition that, in the view of the investigator, would interfere with study participation.
研究组 & 干预措施
HU-014 Inj
Experimental
HU-014 Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)
干预措施: HU-014 Inj (Biological)
Clostridium botulinum type A
Active Comparator
Clostridium botulinum type A Inj was given an injection to 5 Upper limb muscle(Total 360U/, IM)
干预措施: HU-014 Inj (Biological)
结局指标
主要结局
MAS score improvement at Wrist Flexor
时间窗: 4 weeks
The rate of change in muscle tension measured by MAS
次要结局
未报告次要终点
研究者
研究点 (1)
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