Safety Study of Botulinum Toxin Type A in Post-Upper Limb Stroke Patients With Reduced Lung Function
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 155
- 主要终点
- Change From Baseline in Forced Vital Capacity (FVC)
研究概览
简要总结
The purpose of this study is to evaluate the safety of injections of botulinum toxin Type A in patients with reduced lung function and focal upper limb poststroke 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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Abnormal pulmonary function test results;
- •focal, upper limb spasticity, upper motor neuron syndrome
排除标准
- •Previous exposure to botulinum toxin of any serotype
研究组 & 干预措施
1
干预措施: botulinum toxin Type A (Biological)
2
干预措施: botulinum toxin Type A (Biological)
3
干预措施: saline (Drug)
结局指标
主要结局
Change From Baseline in Forced Vital Capacity (FVC)
时间窗: Baseline, Week 6
Change from baseline in observed FVC. FVC is the maximum amount of air exhaled from the lungs after taking the deepest breath possible. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
Change From Baseline in Forced Expiratory Volume (FEV1)
时间窗: Baseline, Week 6
Change from baseline in observed FEV1 at one second. FEV1 is the maximum amount of air exhaled in one second. Patients perform three to eight exhalations into a spirometer with the highest value recorded at Baseline and Week 6.
次要结局
- Change From Baseline in FEV1/FVC Ratio(Baseline, Week 6)
- Change From Baseline in Ashworth Scale(Baseline, Week 6)