Cost Determination Study For Different Botulinum Toxin A Preparations In The Treatment Of Upper Limb Spasticity Post-Stroke In Portugal
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 57
- 试验地点
- 3
- 主要终点
- Estimate the cost of botulinum toxin utilization
研究概览
简要总结
This study aims to estimate the costs of botulinum toxin A utilization in standard practice for the treatment of upper limb spasticity post-stroke in Portugal.
It will consider the three most used locally available brands of botulinum toxin A which show similar efficacy and safety profiles thus making it relevant to understand if choosing between one or another brand can depend directly on economic factors.
The study will estimate direct and indirect drug-associated costs as determinant variables for the price of each drug and the standard drug dose used in clinical practice.
详细描述
A comparison will be performed between direct costs associated with each therapeutic strategy and cost analysis assuming that quality of life values may be different between patients treated with each treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
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
- •Patients diagnosed with post-stroke upper limb spasticity
- •Patients currently being treated with Dysport®, Botox® or Xeomin®
- •Patients stabilized from a therapeutic point of view - with no switches of treatment in at least the 2 last administrations
- •Patients who gave their written informed consent to participate.
排除标准
- •Not applicable.
结局指标
主要结局
Estimate the cost of botulinum toxin utilization
时间窗: 12 months
Direct resource utilization and costs of upper limb spasticity patients treated with BoNT-As, by product
次要结局
- Carer time needed for patient assistance(12 months)
- Number of work days missed due to spasticity(12 months)