A Single Centre, Non-interventional, Retrospective Study to Assess Treatment Outcomes of abobotulinumtoxinA and onabotulinumtoxinA Treatments in Real Life Practice in Toxin-naïve Adult Patients With Limb Spasticity.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Average Goal Attainment Scale (GAS T) score 12 weeks
研究概览
简要总结
The aim of the study is to describe treatment outcomes of abobotulinumtoxinA (aboBoNT-A) and onabotulinumtoxinA (onaBoNT-A) treatments, after one injection of either treatment, in toxin-naïve adult patients with upper and/or lower limb spasticity at a single National Health Service (NHS) centre in the United Kingdom (UK).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Average Goal Attainment Scale (GAS T) score 12 weeks
时间窗: 12 weeks
GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
Proportion of patients who exceed GAS-T score ≥1 for impairment/ symptoms goal
时间窗: 12 weeks
Average Goal Attainment Scale (GAS T) score 6 weeks
时间窗: 6 weeks
GAS, a method that evaluates the attainment of priority goals that are of importance to the patient and has been previously used for the management of patients with limb spasticity. Rating is performed for each domain from -3 "worse than at start" to +2 "much more than expected: clear improvement".
Proportion of patients who achieve GAS-T score ≥0 for impairment/ symptoms goal
时间窗: 6 weeks
次要结局
- Average total dose(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Distribution of vials used(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Distribution of localisation methods(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Distribution of limb and type of muscles injected(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Proportion of patients who require re-injection between aboBoNT-A and onaBoNT-A(Week 6 and week 12 (re-injection))
- Average dose per limb and per type of muscle injected(Day 0 (first BoNT-A injection) and from baseline up to 24 weeks (reinjection))
- Average number of unscheduled visits(From baseline up to end of the study (up to 24 weeks))
- Proportion of patients with ≥1 unscheduled visit(From baseline up to end of the study (up to 24 weeks))
- Proportion of patients with at least "the same", or at least "better" satisfaction with their treatment as measured using a Likert scale(From baseline up to 12 weeks)
- Quality of Life (QoL)(From baseline up to 12 weeks)