NCT03017729已完成不适用
A Phase IV, Prospective, Observational, Multicentre Study Evaluating the Effectiveness and Safety of Dysport® (abobotulinumtoxinA) in Paediatric Lower Limb Spasticity.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 242
- 试验地点
- 24
- 主要终点
- Cumulated GAS T score
研究概览
简要总结
The purpose of this study is to assess the longitudinal attainment of subject centred and functional related goals (cumulated Goal Attainment Scale Total (GAS T) score) after abobotulinumtoxinA injection (including following repeated injection cycles where they occur) alongside spasticity management used in real life settings over a period of 18 months (and a maximum of six injection cycles).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Female or male subjects aged 2 to 17 years inclusive
- •Decision to prescribe abobotulinumtoxinA, to be made prior to and independently from the decision to enroll in the study
- •Primary diagnosis of paediatric lower limb (PLL) spasticity and either: Previously untreated with BoNT (naïve to BoNT), or previously treated with a BoNT (i.e. non naïve to BoNT), and for those who were previously treated with BoNT-A, they should have responded to BoNT-A treatment according to the investigator's criteria
- •For non naïve BoNT subjects, a minimum interval of 12 weeks since the last BoNT injection and in the presence of spasticity
排除标准
- •Known resistance to any BoNT or experienced serious safety issues with previous use of BoNT
- •Concomitant treatment with other BoNT
- •Known hypersensitivity to abobotulinumtoxinA or related compounds, or any component in the study drug formulation
- •Subjects with any clinical (or subclinical) evidence of marked defective neuromuscular transmission (e.g. Lambert Eaton syndrome or myasthenia gravis) or persistent clinically significant neuromuscular disorders
结局指标
主要结局
Cumulated GAS T score
时间窗: From day 1 up to 30 months
Defined as the mean of the individual GAS T scores across all cycles will be used to measure progress towards individual therapy goals. If all goals are achieved as expected, the GAS T score is 50.0.
次要结局
- Time intervals between injections(Day 1, then every 3.5 months (approximately) up to 30 months)
- Type of injection guidance utilised(Day 1, then every 3.5 months (approximately) up to 30 months)
- Sedation used(Day 1, then every 3.5 months (approximately) up to 30 months)
- Non-drug therapies(From day 1 up to 30 months)
- Direct and indirect health care costs(From day 1 up to 30 months)
- AbobotulinumtoxinA dose(Day 1, then every 3.5 months (approximately) up to 30 months)
- Modified Ashworth scale (as applicable) in the injected muscle groups (gastrocnemius, soleus and others) at baseline and per the investigators' decision/routine practice during the course of the study.(From day 1 up to 30 months (per investigator's decision/routine practice))
- Percentage achievement of primary treatment goal(s) per goal area(s) after repeated abobotulinumtoxinA injections(Day 1 then every 3.5 months (approximately) up to 30 months)
- Number of injection points(Day 1, then every 3.5 months (approximately) up to 30 months)
- Muscle(s) injected(Day 1, then every 3.5 months (approximately) up to 30 months)
- Percentage achievement of primary treatment goal(Day 1 then every 3.5 months (approximately) up to 30 months)
- Concomitant drug therapies(From day 1 up to 30 months)
- Average GAS T score(Day 1 then every 3.5 months (approximately) up to 30 months)
- Incidence of adverse events and special situations collected(From day 1 up to 30 months)
研究者
研究点 (24)
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