NCT03908580已完成4 期
A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity
Medy-Tox0 个研究点目标入组 120 人开始时间: 2013年9月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
研究概览
简要总结
This study is "A Prospective, Multi-center, Single Arm, Open-label, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of MEDITOXIN® in Treatment of Post Stroke Upper Limb Spasticity".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Male or female over 20 years.
- •Subjects that was diagnosed with stroke at least 1 month before participating in the clinical trial.
- •Subjects with MAS score of ≥2 for local muscle spasticity of wrist flexor.
排除标准
- •Subjects with generalized neuromuscular junction disorder (ex: myasthenia gravis, Lambert-Eaton syndrome, amyotrophic lateral sclerosis, etc.).
- •Subjects with fixed joint, muscle contracture, or atrophy in the treatment area.
- •Subjects with botulinum toxin treatment within 3 months before administration of the investigational product.
- •Known immunization or hypersensitivity to any botulinum toxin preparations.
- •Subjects who have recieved the following treatments within 4 weeks from screening: Muscle relaxants, Benzodiazepines, Aminoglycosides, Other antibiotics, Anticholinergics
研究组 & 干预措施
Meditoxin®
Experimental
Botulinum toxin type A was intramuscularly injected up to 360U and up to 4 sites, depending on the muscle size.
干预措施: Meditoxin (Drug)
结局指标
主要结局
Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor
时间窗: 4 weeks
Change in muscle tone determined by MAS (Modified Ashworth Scale: Measures resistance during passive soft-tissue stretching; score 0 to 4, 4 being most difficult passive movement) of wrist flexor in subjects with post stroke upper limb spasticity at week 4 after administration compared to baseline.
次要结局
- Change in muscle tone determined by MAS (Modified Ashworth Scale) of elbow flexor and finger flexor(4 weeks, 16 weeks, and 4 weeks after re-visit)
- Change in muscle tone determined by MAS (Modified Ashworth Scale) of wrist flexor(16 weeks, and 4 weeks after re-visit)
- The effective rate of wrist flexor, elbow flexor, and finger flexor(4 weeks, 16 weeks, and 4 weeks after re-visit)
- Change in DAS (Disability Assessment Scale) score(4 weeks, 16 weeks, and 4 weeks after re-visit)
- Change in QOL (SF-36v2; Quality of Life) score(4 weeks, 16 weeks, and 4 weeks after re-visit)
- Subject's or caregiver's global assessment(4 weeks, 16 weeks, and 4 weeks after re-visit)
- Number of participants with Adverse Events (AEs) to assess safety of investigational product.(Through study completion, an average of 1 year)
研究者
相似试验
已完成
不适用
Correlation Study Between PEST and SCORAD in Management of Atopic Dermatitis With Ceradan® RegimenAtopic DermatitisNCT02073591Hyphens Pharma Pte Ltd58
已完成
4 期
Efficacy and Safety of Poly-L-lactic AcidButtock ContouringButtock LiftingNCT03922464Erevna Innovations Inc.30
已完成
4 期
A Study of Trastuzumab Emtansine in Indian Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer Who Have Received Prior Treatment With Trastuzumab and a TaxaneHER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast CancerNCT02658734Hoffmann-La Roche70
已完成
4 期
Efficacy and Safety of Ikervis Under Controlled Environmental Conditions EnvironmentDry Eye SyndromesSevere KeratitisDry EyeNCT04492878Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA25
已完成
4 期
A Study of Tocilizumab in Chinese Participants With Systemic Juvenile Idiopathic Arthritis (sJIA)Juvenile Idiopathic ArthritisNCT03301883Hoffmann-La Roche62