EUCTR2017-004497-33-DK进行中（未招募）1 期
Measuring effects on pain and quality of life after Dysport® injection in children with cerebral palsy
Copenhagen University Hospital at Hvidovre0 个研究点目标入组 36 人开始时间: 2017年12月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Diagnosed with spastic cerebral palsy
- •- GFMCS 1-5.
- •- Age 2-18
- •- Having a pain response by the revised and individualized Face Legs Activity Cry and Consolability (rFLACC) for muscles with spasticity (MAS score = 1 and a spasticity grade of 1-4 on the Tardieu scale) during the passive range of motion by the treating physician.
- •- Requiring BonTA injection for their spasticity
- •- having had a washout period of at least 6 month from last injection of botulinum toxin
- •- Dynamic Myocontracture /spasticity in the painful limb (MAS score = 1 and a spasticity grade of 1-4 on the Tardieu scale)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 36
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Fixed myocontracture (Reduced and static passive range of motion)
- •- Severe athetoid/dystonic movements in the targeted leg(s)
- •Relative exclusion criteria
- •Prior and recent surgery that might influence the pain evaluation is a contraindication and will be evaluated on an individual basis for the specific test subject by the principle investigator.
研究者
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