NCT00455637终止2 期
A Phase II, 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
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Ipsen
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
研究概览
简要总结
The purpose of the study is to compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 4 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged between 4 and 16 years (inclusive).
- •Diagnosis of cerebral palsy.
- •Presence of clinical bilateral hip pain (of at least 6 months duration) due to cerebral palsy as defined by the child/young person and/or parents.
- •Paediatric Pain Profile score of 25 or greater.
排除标准
- •Prior treatment with Botulinum toxin (any serotype, administered anywhere in the body) within 4 months prior to Screening.
- •Planned or anticipated requirement for surgery during the study period.
- •History of hypersensitivity to the investigational drug or any of its excipients.
- •Likely to require treatment during the study with drugs that are not permitted by the study protocol or that in the opinion of the Investigator may interfere with the evaluation of the efficacy or safety of the study medication.
研究组 & 干预措施
Dysport 10 units
Experimental
干预措施: Botulinum toxin type A (Biological)
Dysport 15 units
Experimental
干预措施: Botulinum toxin type A (Biological)
Dysport 5 units
Experimental
干预措施: Botulinum toxin type A (Biological)
结局指标
主要结局
To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of chronic bilateral hip pain due to cerebral palsy in children/young people.
时间窗: From baseline to the end of study (week 20)
The primary endpoint will be the change in score in the Paediatric Pain Profile.
时间窗: From baseline to the week 4 assessment
次要结局
- To compare the effectiveness of 3 doses of Dysport (5, 10 or 15 Units/Kg/hip) in the management of hip pain as assessed by the change in the score of the Paediatric Pain Profile at all other assessment time points.(Weeks 12, 16 and 20)
- To compare the effect of the different doses of Dysport on sleep pattern and quality as assessed using a sleep diary and sleep questionnaire at all assessment time points.(Weeks 4, 12, 16 and 20)
- To compare the effect of the different doses of Dysport on oral analgesia intake for hip pain at all assessment time points.(Weeks 4, 12, 16 and 20)
研究者
研究点 (2)
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