An Observational, Prospective, Multicentre, National Trial on the Benefit of Botulinum Toxin Type A (BoNT-A) Injections in Untreated Chronic Post-stroke Spastic Brazilian Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 239
- 试验地点
- 11
- 主要终点
- Change in Goal Achievement Score (GAS).
研究概览
简要总结
The purpose of this study is to document the effectiveness of treating chronic post-stroke spastic patients with Botulinum Toxin type A.
详细描述
As this is a non-interventional study, the decision to prescribe the product must be taken prior to, and independently from the decision to enrol the patient. This decision should be made in accordance with routine clinical practice at the hospital concerned. The clinical justification for prescribing any treatment should be recorded at the outset by the prescribing clinician.
This study will not interfere with the routine practice of the investigator or with the patient's treatment plan. Assessments will be done only if performed regularly in routine practice.
This study will be conducted in Brazil, wherein Marketing Authorization has been granted for the use of BoNT-A in the treatment of spasticity of the upper and lower limb in adult post-stroke patients.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Time between last documented stroke (either haemorrhagic or ischemic) and study inclusion date equal or longer than 1 year
- •Documented upper limb spasticity, with or without lower limb spasticity
- •Naive to BoNT-A injections for spasticity treatment
- •Provide written informed consent (signed by the patient or his legal representative) prior to any study-related procedure
排除标准
- •Previous surgical procedure for spasticity treatment, including neurotomy, rhizotomy and intrathecal pump implants
- •Previous phenol injection and/or indication to receive phenol during the study duration
- •Contraindications to any BoNT-A preparations
- •Patient and/or caregiver unable to comply with the study requirements
- •The patient has already been included in the study
结局指标
主要结局
Change in Goal Achievement Score (GAS).
时间窗: 3 and 6 months
次要结局
- Change from baseline in functional independence according to Barthel index score(Baseline and 3 months)
- Change from baseline in pain according to Verbal Numerical Scale (VNS).(Baseline and 3 months)
- Change from baseline in Modified Ashworth Scale (MAS) score(Baseline and 3 months)
- Change from baseline in Quality of Life according to Euro-5D-5L health questionnaire(Baseline and 3 months)