A Phase III, Multicentre, Double-blind, Prospective, Randomized, Placebo-controlled Study, Assessing the Efficacy and Safety of Dysport® Used for the Treatment of Lower-limb Spasticity in Adult Subjects With Hemiparesis Due to Stroke or Traumatic Brain Injury
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 388
- 试验地点
- 61
- 主要终点
- Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
研究概览
简要总结
The purpose of this research study is to assess the efficacy of Dysport® compared to placebo in improving muscle tone in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury.
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, 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
- •Subjects aged 18 to 80 years of age
- •Post stroke or brain injury
- •Intensity of muscle tone greater than or equal to 2, as measured on the Modified Ashworth Scale
- •Ambulatory patients
排除标准
- •Fixed contractures
- •Physiotherapy initiated less than 4 weeks before entry
- •Previous surgery or previous treatment with phenol and/or alcohol in lower limb
- •Neurological/neuromuscular disorders which may interfere with protocol evaluations
研究组 & 干预措施
Dysport® 1000 U, IM
1000 U, I.M. (in the muscle), on day 1 (single treatment cycle)
干预措施: Botulinum toxin type A (Biological)
Dysport® 1500 U, IM
1500 U, I.M., on day 1 (single treatment cycle)
干预措施: Botulinum toxin type A (Biological)
Placebo
I.M., on day 1 (single treatment cycle)
干预措施: Placebo (Drug)
结局指标
主要结局
Least Squares Mean Change From Baseline to Week 4 in the MAS Score in the Gastrocnemius-soleus Complex (GSC) (Knee Extended)
时间窗: Baseline and Week 4
Muscle tone in the treated limb was assessed by MAS in the GSC (with the knee extended) at baseline, at Weeks 1, 4 and 12, at discretionary visits at Weeks 16, 20 and 24, and at end of study. The MAS consists of 6 grades: 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 (ROM)), 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), 3 (considerable increase in muscle tone) or 4 (affected part(s) rigid in flexion or extension), and can be applied to muscles of both the upper and lower limbs. The least squares mean change from baseline at Week 4 is reported.
次要结局
- Physician's Global Assesment (PGA) of Treatment Response at Week 4(At Week 4)
- Least Squares Mean Change From Baseline to Week 4 in Comfortable Barefoot Walking Speed(Baseline and Week 4)