A Phase III, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT® Used In The Treatment Of Upper Limb Spasticity In Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 212
- 试验地点
- 31
- 主要终点
- Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of multiple doses of Dysport used in the treatment of upper limb spasticity (altered skeletal muscle performance) in children with cerebral palsy (CP).
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
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Upper limb spasticity due to cerebral palsy
- •Body weight 10 kg or over
- •MAS score of 2 or more in affected elbow or wrist flexors
排除标准
- •Fixed myocontracture
- •Previous phenol or alcohol injection within 1 year
- •Severe athetoid or dystonic movements
- •Previous or planned surgery for spasticity in elbow or wrist flexors
- •Neuromuscular disorders
- •Previous Rhizotomy within 6 months
- •Intrathecal baclofen within 30 days
结局指标
主要结局
Mean Change From Baseline to TC 1, Week 6 in MAS Score in the TC 1 PTMG
时间窗: Baseline (TC 1, Day 1) and TC 1, Week 6.
The MAS was used to assess muscle tone in the upper limb PTMG and 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 ROM) when the affected part is moved in flexion or extension, 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). The original score '+1' was given a derived numeric score of '2' and the higher numeric scores were incremented by 1 so that the MAS score range was from 0 to 5 with higher scores indicating greater muscle tone. A negative change from baseline indicates a decrease in muscle tone.
次要结局
- Mean Physician's Global Assessment (PGA) Score at TC 1, Week 6(TC 1, Week 6.)
- Mean Goal Attainment Scale (GAS) Total Score at TC 1, Week 6(TC 1, Week 6.)