A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport® Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic 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
- 243
- 试验地点
- 39
- 主要终点
- Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)
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 upper 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
- •Adult patients - post stroke or brain injury
- •Modified Ashworth Scale ≥ 2
- •Ambulatory patients
排除标准
- •Previous treatment with botulinum toxin of any type within 4 months prior to study entry for any condition
- •Physiotherapy initiated less than 4 weeks before inclusion
- •Previous surgery, alcohol, phenol in upper limb
- •Neurological/neuromuscular disorders which may interfere with protocol evaluations
研究组 & 干预措施
Dysport 500 U
干预措施: Botulinum toxin type A (Biological)
Dysport 1000 U
干预措施: Botulinum toxin type A (Biological)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in MAS Score in the Primary Targeted Muscle Group (PTMG)
时间窗: From Baseline (Day 1) to Week 4
MAS scale is used to assess muscle tone using a 6-point scale where: 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) when the part is flexed or extended, 1±Slight increase in muscle tone manifested by a catch followed by minimal resistance throughout the remainder of the ROM, 2=Marked increase in muscle tone through most of the ROM but affected part easily moved, 3=Considerable increase in muscle tone passive movement difficult or 4=Affected part(s) rigid in flexion or extension. The MAS has been derived for analyses as follows: 0=0 ; 1=1; 1+=2; 2=3; 3=4 and 4=5.
次要结局
- Physician's Global Assessment (PGA) of Treatment Response(At Week 4)
- Change From Baseline in DAS Score for the Principal Target of Treatment (PTT)(From Baseline (Day 1) to Week 4)