A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT® Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 241
- 试验地点
- 29
- 主要终点
- Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb
研究概览
简要总结
The purpose of this research study is to determine whether Dysport® is effective in the treatment of increased stiffness of the calf muscles and to evaluate the safety of this treatment in children with Cerebral Palsy. In addition this study will also check whether Dysport® can lessen the pain caused by spasticity and improve the child's wellbeing.
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 2 to 17 years with cerebral palsy
- •Equinus foot position
- •Ambulatory
- •Intensity of muscle tone equal to or greater than 2 in affected lower limb, as measured on the Modified Ashworth Scale
排除标准
- •Fixed contracture
- •Previous phenol, alcohol injection or surgical intervention
- •Other neurological / neuromuscular disorder
- •Severe athetoid or dystonic movements
研究组 & 干预措施
Dysport 10 U/Kg
10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
干预措施: Botulinum toxin type A (Biological)
Dysport 15 U/Kg
15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.
干预措施: Botulinum toxin type A (Biological)
Placebo
Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in MAS Score in the Gastrocnemius-soleus Complex (GSC) at the Ankle Joint of the (Most) Affected Lower Limb
时间窗: Change from baseline to Week 4
The MAS is a 6-point scale which measures the intensity of muscle tone by measuring the resistance of the muscle to passive lengthening or stretching. Investigator will grade muscle tone in the GSC from 0 (no increase in tone) to 4 (affected parts rigid in flexion or extension).
次要结局
- Goal Attainment Scale (GAS) Score(Week 4)
- Physician's Global Assessment (PGA) of the Treatment Response.(Week 4)