OnabotulinumtoxinA Treatment in Adult Patients With Upper Limb Spasticity
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 53
- 主要终点
- Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
研究概览
简要总结
This is a safety and efficacy study of onabotulinumtoxinA in poststroke patients with 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper limb spasticity in the elbow and shoulder due to stroke, with the most recent stroke at least 3 months ago
排除标准
- •Spasticity in the non-study upper limb that requires treatment
- •Presence of fixed contractures in of the study muscles in elbow or shoulder
- •Profound atrophy of muscles to be injected
- •Previous surgical intervention, nerve block, or muscle block for the treatment of spasticity in the study limb in the last 12 months
- •Injection of corticosteroids or anesthetics, use of casting or dynamic splinting or constraint-induced movement therapy (CIMT) for the study limb within 3 months
- •Ultrasound therapy, electrical stimulation, or acupuncture in the study limb within 1 month
- •Condition other than stroke contributing to upper limb spasticity
- •Diagnosis of myasthenia gravis, Eaton-Lambert syndrome, and/or amyotrophic lateral sclerosis
研究组 & 干预措施
onabotulinumtoxinA 500U
OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
干预措施: onabotulinumtoxinA (Biological)
onabotulinumtoxinA 300U
OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
干预措施: onabotulinumtoxinA (Biological)
placebo (normal saline)
Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
干预措施: placebo (normal saline) (Drug)
结局指标
主要结局
Change From Baseline in the Modified Ashworth Scale-Bohannon (MAS-B) Score of Elbow Flexors Using a 6-Point Scale
时间窗: Baseline, Week 6
The MAS-B is a 6-point scale used to evaluate spasticity based on grading the resistance encountered in the elbow flexors by passively moving the elbow flexor muscles through their range of motion. The score ranges from 0 (no increase in muscle tone) to 4 (affected part(s) rigid in flexion or extension). Scores are converted to a 0 to 5 grade. A negative number change from baseline indicates an improvement and a positive number change from baseline indicates a worsening.
次要结局
- Change From Baseline in the MAS-B Score of Shoulder Adductors Using a 6-Point Scale(Baseline, Week 6)
- Change From Baseline in Pain on an 11-Point Scale(Baseline, Week 6)
- Change From Baseline in the Dressing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)(Baseline, Week 6)
- Change From Baseline in the Showering/Bathing Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)(Baseline, Week 6)
- Change From Baseline in the Self-Care Domain Score on the Spasticity Impact Assessment-Upper Limb (SIA-UL)(Baseline, Week 6)