NCT04604379已完成不适用
A Multicentre, Non-interventional Retrospective Study of Treatment Outcomes From Treatment With Dysport ® (Clostridium Botulinum Type A Toxin-haemagglutinin Complex, Abobotulinumtoxin-A) Injections in Adults for Upper and/or Lower Limb Focal Spasticity in Real-world Clinical Practice in the United Kingdom
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
- 123
- 试验地点
- 3
- 主要终点
- Average total dose of AboBoNT-A for focal upper limb and/or lower limb spasticity per treatment session
研究概览
简要总结
The aim of this retrospective study is to describe the real-world outcomes with the treatment of adult patients with Dysport® injections for focal upper limb spasticity (ULS) and/or focal lower limb spasticity (LLS) in NHS hospital settings 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
- •Adult patients diagnosed with focal ULS and/or LLS for whom aboBoNT-A (Dysport®) was prescribed in line with the SmPC (according to clinician judgement).
- •Patients initiated on aboBoNT-A for focal ULS after the 31st January 2016 and/or for focal LLS after the 06th December
- •Patients receiving ≥1 injection(s) (i.e. ≥1 treatment cycle) of aboBoNT-A during the observation period, in line with Dysport® Summary of Product Characteristics (SmPC).
- •Patients aged ≥18 years old at the time of the first aboBoNT-A injection for focal ULS and/or LLS.
- •Patient is naïve to treatment with any type of BoNT-A during the 6 months prior to initiation of aboBoNT-A.
- •Patients treated at the participating centre for the duration of the observation period, with data recorded in the medical records available for review.
排除标准
- •Patients with an interval of <12 weeks between aboBoNT-A treatments
- •Patients are participating (or who have participated) in an interventional clinical trial of an investigational medicinal product indicated for spasticity which may influence and confound the real-world data collected for this study.
- •Patients treated with aboBoNT-A off-license, this may include off-license indications, muscles indicated for injection or dosing
结局指标
主要结局
Average total dose of AboBoNT-A for focal upper limb and/or lower limb spasticity per treatment session
时间窗: From baseline (when each patient received their first treatment) to 52 weeks (±6 weeks) post baseline
Average interval between AboBoNT-A injections throughout the observation period for focal ULS and/or LLS
时间窗: From baseline to 52 weeks (±6 weeks) post baseline
次要结局
- Average age at diagnosis of neurological condition(Baseline)
- Average age at first AboBoNT-A injection(Baseline)
- Average age at diagnosis of spasticity(Baseline)
- Sex distribution (Male, Female)(Baseline)
- Presence of underlying neurological condition: stroke, injury, chronic disease (multiple sclerosis, other)(Baseline)
- Presence of location of spasticity (specify: right lower limb, left lower limb, right upper limb, left upper limb, unilateral, bilateral spasticity for lower and upper limb)(Baseline)
- Presence of previous spasticity-related treatments ongoing at index event, if available: antispasticity medications, pain medications and opioids, neurolytic agent, surgery, physiotherapy and occupational therapy(Baseline)
- Presence of comorbidities: bowel conditions (irritable bowel syndrome, irritable bowel disease), urinary tract infections, chest infections, anxiety or depression, alcohol dependence/substance abuse.(Baseline)
研究者
研究点 (3)
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