Prospective, Double-blind, Placebo-controlled, Randomized, Multi-center Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Post-stroke Spasticity of the Lower Limb
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 53
- 主要终点
- Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4
研究概览
简要总结
The purpose of this study is to determine whether injections of Botulinum toxin type A into muscles of the leg are effective in treating patients with increased muscle tension/uncontrollable muscle stiffness (spasticity) after a stroke.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age from 18-80 yrs
- •Lower limb spasticity
- •Time since stroke greater than 3 months
- •Need for 400 U Botulinum toxin type A
排除标准
- •Body weight below 50kg
- •Fixed contractures of the lower limb
- •Generalized disorders of muscle activity like Myasthenia gravis that preclude use of Botulinum toxin type A
- •Infection at the injection site
研究组 & 干预措施
IncobotulinumtoxinA (Xeomin) 400 Units
IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
干预措施: IncobotulinumtoxinA (400 Units) (Drug)
Placebo Comparator Arm
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Change From Baseline in Ashworth Scale (AS) for Plantar Flexors at Week 4
时间窗: Baseline and Week 4
The AS 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).
Co-primary Variable: Investigator's Global Assessment of Efficacy at Week 12
时间窗: Baseline to Week 12
A 4-point Likert scale will be used with the ratings 1 = very good, 2 = good, 3 = moderate, and 4 = poor. Investigator's Global Assessment of Efficacy at Week 12 will be a co-primary outcome measure to fulfill post marketing commitments for U.S. regulatory authorities only. Elsewhere, it will be a secondary outcome measure.
次要结局
- Response Rate for Plantar Flexors at All Post-Baseline Visits for Subjects With an Improvement (Reduction) of at Least 1 Point From Baseline in the Ashworth Scale (AS)(Week 4, 8, and 12)
- Ashworth Scale (AS) for Plantar Flexors at All Post-Baseline Visits(Baseline, Week 4, 8, and 12)