A Retrospective Multicenter Study Assessing Adult Subjects Affected With Upper and/or Lower Limb Spasticity Treated With Botulinum Neurotoxin Type A (Result Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- Average interval between BoNT-A injections
研究概览
简要总结
The aim of the study is to describe the long term use of Botulinum Neurotoxin Type A (BoNT-A) in adult subjects affected with upper and/or lower limb spasticity who received treatment with BoNT-A for a minimum of three injections cycles at three Italian centers.
The study has a retrospective design and data relating to subjects' injections cycles occurred in the past are collected. Period of observation defined in the protocol is from 2008 to 2018, but it could change for each subject according to the number of injections cycles performed. Time frame for data collection is 12 months from study start.
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 aged ≥18 years old at the time of the first BoNT-A injection
- •Diagnosed with spasticity with any cause (excluded CP)
- •Treated with a minimum of three BoNT-A treatment cycles for upper limb spasticity (ULS) and/or lower limb spasticity (LLS)
- •With follow up data available in the subject's medical record
- •Provision of written informed consent form, to the extent required according to applicable national local regulations for a retrospective, non-interventional study
排除标准
- •Treatments and assessments were performed at more than one centre
结局指标
主要结局
Average interval between BoNT-A injections
时间窗: From the baseline to the end of the study (12 months)
Average interval between BoNT-A injections in upper and/or lower limbs for BoNT-A overall (regardless of BoNT-A type) and per BoNT-A type
Average total dose of BoNT-A
时间窗: From the baseline to the end of the study (12 months)
Average total dose per BoNT-A type in upper and/or lower limbs (this is the average total dose injected during all sessions per BoNT-A type during the study period)
次要结局
- Average total dose per BoNT-A type in upper limbs(From the baseline to the end of the study (12 months))
- Average total dose per BoNT-A type in lower limbs(From the baseline to the end of the study (12 months))
- Average total dose per muscle in lower limbs(From the baseline to the end of the study (12 months))
- Occurrence of treatment discontinuation(From the baseline to the end of the study (12 months))
- Global Treatment Satisfaction (GTS)(From the baseline to the end of the study (12 months))
- Number of BoNT-A injection cycles(From the baseline to the end of the study (12 months))
- Average total dose per muscle in upper limbs(From the baseline to the end of the study (12 months))
- Number of switches between BoNT-A preparations(From the baseline to the end of the study (12 months))
- Reason for injection(From the baseline to the end of the study (12 months))
- Reason for interruption(From the baseline to the end of the study (12 months))