A Randomized, Double Blind, Multi-center, Active Drug Controlled Clinical Trial to Compare the Efficacy and Safety of MEDITOXIN® Versus BOTOX® in Treatment of Post Stroke Upper Limb Spasticity
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- MAS(Modified Ashworth Scale) of Wrist Flexor
研究概览
简要总结
This study is a randomized, double blind, multi-center, active drug controlled, phase III clinical trial to compare the efficacy and safety of MEDITOXIN® versus BOTOX® in treatment of post stroke upper limb(wrist, finger, thumb) spasticity
Approximately 196 subjects(1:1 group ratio)will be enrolled. Subjects will receive a single treatment of intramuscular Investigational product up to 360U. The subjects will be observed every 4 weeks until 12 weeks post injection. Outcome measures include Modified Ashworth Scale (MAS), Disability Assessment Scale (DAS), Global Assessment Scale(patient or caregiver/investigator) and Carer burden scale. The primary efficacy endpoint is the change from baseline at week 4 for wrist flexor muscle tone as measured on the Modified Ashworth Scale. Safety parameters will also be measured including adverse events, vital signs and clinical laboratory tests (haematology, serum chemistry and urinanalysis).
详细描述
Each completed subject will attend 4~5 clinic visits. The maximum study duration is 15 weeks. Only one upper limb (eligible inclusion/exclusion criteria) will be injected and evaluated in the study. Maximun injection dose is 360U.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 20 years
- •≥ 6 weeks since the last stroke
- •≥ 2 points in the focal spasticity of wrist flexor and ≥ 1 points at least one of elbow flexor and finger flexor as measured on MAS(0 to 4)
- •Targeted one functional disability item (i.e., hygiene, dressing, pain, or cosmesis) with a rating of 2 or greater on DAS (0 to 3)
- •Informed consent has been obtained.
排除标准
- •Neuromuscular disorders such as Lambert-Eaton syndrome, myasthenia gravis, or amyotrophic lateral sclerosis
- •History(within 6 months of screening visit) or planned(during study period) treatment with phenol or alcohol injection or surgery in the target limb
- •History(within 6 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
- •History(within 3 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
- •If these therapy regimens will be permitted if they has 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, breatfeeding,or planning a pregnancy during the study period, or female of childbearing potential, not using a reliable means of centraception.
- •Patients who are not eligible for this study at the discretion of the investigator.
研究组 & 干预措施
Meditoxin®
Botulinum toxin type A
干预措施: Botulinum Toxin type A (Drug)
Botox®
Botulinum Toxin type A
干预措施: Botulinum Toxin type A (Drug)
结局指标
主要结局
MAS(Modified Ashworth Scale) of Wrist Flexor
时间窗: Baseline and 4 weeks
Change from baseline at week 4 for wrist flexor muscle tone as measured on the MAS(Modified Ashworth Scale). The Modified Ashworth Scale is a well known and commonly used scale in clinical trials with spasticity. It was considered to be the best clinical tool for measuring resistance to movement. It was used to categorize the severity of spasticity by judging resistance to passive movement. It is a 5-point scale that ranges from 0 (=no increase in tone) to 4 (=limb rigid in flexion or extension).
次要结局
- Improvement Rate on the MAS(Modified Ashworth Score) of Wrist Flexor(week 4, week 8, week 12)
- Global Assessment by Patient or Caregiver(week 12)
- MAS(Modified Ashworth Scale) of Wrist Flexor(Baseline, week 8 and week 12)
- MAS(Modified Ashworth Score) of Elbow Flexor(Baseline, week 4, week 8 and week 12)
- MAS(Modified Ashworth Score) of Finger Flexor(Baseline, week 4, week 8 and week 12)
- MAS(Modified Ashworth Score) of Thumb Flexor(Baseline, week 4, week 8 and week 12)
- Improvement Rate on the MAS(Modified Ashworth Score) of Elbow Flexor(week 4, week 8, week 12)
- Improvement Rate on the MAS(Modified Ashworth Score) of Thumb Flexor(week 4, week 8, week 12)
- Carer Burden Scale of Cutting the Finger-nails(Baseline, week 4, week 8 and week 12)
- Carer Burden Scale of Cleaning the Armpit(Baseline, week 4, week 8 and week 12)
- Improvement Rate on the MAS(Modified Ashworth Score) of Finger Flexor(week 4, week 8, week 12)
- Carer Burden Scale of Cleaning the Palm(Baseline, week 4, week 8 and week 12)
- DAS(Disability Assessment Scale) of Hygiene(Baseline, week 4, week 8 and week 12)
- Carer Burden Scale of Putting Shirts on(Baseline, week 4, week 8 and week 12)
- DAS(Disability Assessment Scale) of Dressing(Baseline, week 4, week 8 and week 12)
- DAS(Disability Assessment Scale) of Limb Position(Baseline, week 4, week 8 and week 12)
- DAS(Disability Assessment Scale) of Pain(Baseline, week 4, week 8 and week 12)
- Global Assessment by Investigator(week 12)