Dose-response Relationship of Botullinum Toxin (DWP 450) for Finger Flexor Spasticity
试验速览
- 阶段
- 4 期
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- MAS (Modified Ashworth Scale)
研究概览
简要总结
Study Design: Randomized Single Blind Study Objective: To determine the dose relationship of DWP 450 for finger flexor spasticity Subjects: 78 patients with upper extremity spasticity after CVA Inclusion criteria: Patient who have spasticity (MAS greater than 2 in finger flexors) Methods: Patients will be randomly assigned to one of 5 groups. Gp 1: placebo, Gp 2: 15U, Gp 3: 30 U, Gp 4: 50 U, Gp 5: 75 U
详细描述
Seventy-eight patients with upper extremity spasticity after cerebrovascular accident will be recruited and randomly assigned to one of 5 groups. The groups are as followings.
Gp 1: placebo group (Normal saline 1.2 ml) Gp 2: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U Gp 3: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U Gp 4: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U Gp 5: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U
According to the group, the injection will be performed to the finger flexor musles (flexor digitorum superficialis and profundus). Outcome measurement will be MAS (Modified ashworth scale), FMA, Wolf Motor Assessment, Cross sectional area measured by Ultrasonography.
Patient evaluation will be conducted 2 weeks, 1 months, 2 months, and 3 months after the injection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •over 6 weeks after stroke onset
- •MAS (modified Ashworth scale) greater than 2 in finger flexor
排除标准
- •neuromuscular junction disease or motor neuron disease
- •phenol or alcohol block for the target limbs within 6 months before screening
- •botulinum toxin injection within 3 months before screening
- •history or plan for tendon lengthening surgery
- •significant contracture ormuscle atrophy at the target joint or muscle
- •concurrent treatment with intrathecal baclofen
- •hypersensitivity or allergy to study drug or its components
- •pregnancy or planned pregnancy, breastfeeding
- •abnormal lab findings for alanine aminotransferase, aspartate aminotransferase, blood urea nitrogen, and serum creatinine.
研究组 & 干预措施
Placebo
Normal Saline 0.9% 1.2 ml will be injected to finger flexor muscles
干预措施: Normal Saline 0.9% 1.2 ml (Drug)
Treatment dose 15
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U will be injected to finger flexor muscles
干预措施: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U (Drug)
Treatment dose 30
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U will be injected to finger flexor muscles
干预措施: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U (Drug)
Treatment dose 50
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U will be injected to finger flexor muscles
干预措施: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U (Drug)
Treatment dose 70
Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U will be injected to finger flexor muscles
干预措施: Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U (Drug)
结局指标
主要结局
MAS (Modified Ashworth Scale)
时间窗: 12wks after injection
Spasticity measurement measures resistance during passive soft-tissue stretching(taken from Bohannon and Smith, 1987): 0: No increase in muscle tone 1. Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+: Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the ROM 2. More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3. Considerable increase in muscle tone, passive movement difficult 4. Affected part(s) rigid in flexion or extension
次要结局
- Ultrasonography(12wks after injection)
- Fugl Myer Upper Extremity Assessment(12 wks after injection)
- Wolf Motor Assessment(12 wks after injection)
研究者
Shi-Uk Lee
Professor
Seoul National University Hospital