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临床试验/NCT04446702
NCT04446702已完成不适用

Retrospective Real-life Study From One Brazilian Reference Centre Assessing Long-term Experience in the Treatment of Adult Spasticity With AbobotulinumtoxinA (RETURN Study)

Ipsen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年3月5日最近更新:
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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
200
试验地点
1
主要终点
Average total dose injected during all sessions of Dysport® in ULS +/- LLS
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The aim of the study is to describe the long-term use of abobotulinumtoxinA (Dysport®) in adult subjects affected with upper limb spasticity (ULS) +/- lower limb spasticity (LLS) who received treatment with Dysport® for a minimum of three injections cycles at the Instituto de Medicina Física e Reabilitação do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (IMREA HC FMUSP) in Brazil.

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
是

入选标准

  • •Adult aged ≥18 years old at the time of the first Dysport® injection
  • •Diagnosed with spasticity
  • •Treated with a minimum of three Dysport® injection cycles for ULS +/- LLS in the observational period
  • •Follow up effectiveness data are available in the subject's medical record

排除标准

  • •Patients have received previous treatment with another BoNT-A less than 12 weeks prior to the patient data collection in the study
  • •Adults with cerebral palsy
  • •Patients treated with BoNT-A in a clinical trial setting

结局指标

主要结局

Average total dose injected during all sessions of Dysport® in ULS +/- LLS

时间窗: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)

Average interval between Dysport® injections in ULS +/- LLS

时间窗: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)

Median total dose injected during all sessions of Dysport® in ULS +/- LLS

时间窗: From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019)

次要结局

  • Total time exposure to Dysport® treatment in ULS +/- LLS(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Changes in Modified Ashworth Scale (MAS) scores by time period per muscle(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Changes in Functional Independence Measure (FIM) subscales(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Total number of Dysport® injection cycles(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Total dose injected per cycle, per limb, per muscle and overall(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Number of Dysport® interruptions(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Changes in Pain score according to pain Visual Analogue Scales (VAS)(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Gait pattern evaluation in patients with LLS(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Concomitant drugs for the management of patients with ULS +/- LLS(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Reported reason for Dysport® injection and for change(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Baseline subjects characteristics(Baseline (first Dysport® injection))
  • Number of muscles injected in ULS +/- LLS(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Reasons of Dysport® discontinuation(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019).)
  • Non-drug concomitant therapies for the management of patients with ULS +/- LLS(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))
  • Incidence and intensity of Adverse Events(From baseline (visit 1) and up to the last injection during data record (January 1st, 2006 to July 31st, 2019))

研究者

发起方
Ipsen
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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