Asian Multicentre, Double Blind, Randomised, Placebo Controlled Pilot Study, to Assess the Impact of Dysport® Intramuscular Injections When Administered Within the First 12 Weeks After Stroke on the Time to Spasticity Progression in Adult Subjects With Upper Limb (UL) Spasticity.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms
研究概览
简要总结
The purpose of this study is to investigate if early administration (i.e. within 12 weeks after stroke) of Dysport® 500 U injections may delay the appearance or the progression of upper limb symptomatic 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
- Double (Participant, 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
- •2 to 12 weeks after first ever stroke according to the World Health Organisation criteria (previous transient ischaemic attack or clinically silent infarct on computerised tomography (CT)/magnetic resonance imaging (MRI) are not counted as previous stroke)
- •Stroke confirmed by CT/MRI scan and classified as ischaemic/haemorrhagic stroke
- •Presence of spasticity:
- •either symptomatic, based on symptomatic spasticity criteria (i.e. at least one of the following items: impacted passive/active function, involuntary movements, or pain ≥4 on a numeric pain rating scale [NPRS]), in addition to increased muscle tone [Modified Ashworth Scale, MAS ≥2])
- •or only increased muscle tone (MAS≥2)
排除标准
- •Neuromuscular junction (NMJ) diseases, or any other neurological disorders (including prior local joint, tendon, and intrinsic muscle disorders) that could potentially interfere with assessment of spasticity in the primary targeted muscle group selected by the Investigator and in agreement with the subject
- •Currently receiving drugs affecting NMJ transmission e.g. aminoglycosides, aminoquinolines, cyclosporine, D penicillamine
- •Previous surgery of the affected muscles/ ligaments/tendons
- •Severe comorbidities (e.g. congestive heart failure, myocardial infarction, multiple organ failure, hepatic renal failures, severe infections)
研究组 & 干预措施
Treatment group
Dysport® 500U intramuscular injection
干预措施: Botulinum toxin type A (Biological)
Placebo Group
Placebo intramuscular injection
干预措施: Placebo (Drug)
结局指标
主要结局
Time Between the Initial Injection and the Appearance of Reinjection Criteria as Evaluated by the Modified Ashworth Scale (MAS) and Spasticity Symptoms
时间窗: From Week 4 up to Week 28
The appearance of increased muscle tone was assessed using the MAS (scale ranges from 0 \[no increase in muscle tone\] to 4 \[affected part rigid in flexion or extension\]). For confirmation of reinjection criteria appearance, a subject had to have a MAS score in the primary targeted muscle group of ≥2 and at least 1 of the following 4 criteria confirming signs of symptomatic spasticity in the UL: 1. A Numeric Pain Rating Scale (NPRS) pain score ≥ 4 (NPRS ranges from 0 \[no pain\] to 10 \[severe pain\]) 2. An impact on passive function measured by a score of ≥ 1 on the 4-point Likert scale (scale ranges from 0 \[no impact\] to 3 \[severe impact\]) 3. An impact on active function measured by a score of ≥ 1 on the 4-point Likert scale 4. An involuntary movements score ≥1 on the 4-point Likert scale in relevant upper limb. Results are reported overall for subjects with both symptomatic and asymptomatic spasticity.
次要结局
- Mean Change in MAS of the Primary Targeted Muscle Group.(From baseline up to Week 28)
- Mean Change in Fugl-Meyer Assessment for Evaluation of UL Motor Impairment.(From baseline up to Week 28)
- Global Assessment of Changes at Last Visit(From Week 4 up to Week 28)
- Number of Concomitant Non-drug Therapy Sessions.(From baseline up to Week 28)
- Mean Duration of Concomitant Non-drug Therapy Sessions.(From baseline up to Week 28)