EUCTR2005-001794-10-GB进行中（未招募）不适用
A Phase IV, Randomised, Double-blind, Dose-ranging, Study in Children and Young People to determine the Optimal Dose of Botulinum Toxin Type-A (Dysport®) in Managing the Symptoms of Hip Muscle Spasticity due to Cerebral Palsy - Use of Dysport in Managing Symptoms of Hip Muscle Spasticity in Cerebral Palsy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ipsen Ltd
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
- •Written (personally signed and dated) informed consent given by the patient’s parent or guardian. Written informed assent given by the patient (if possible).
- •Male or female aged between 4 and 16 years (inclusive).
- •Diagnosis of cerebral palsy.
- •Presence of clinical hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child and/or parents.
- •Paediatric Pain Profile score of 25 or greater.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening.
- •Pregnancy or lactation.
- •Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude, unless the disease under study is such that the patient presents with such symptoms and the consent of a legal guardian or carer must be sought (providing the latter is permitted by the local legislation).
研究者
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