Subcutaneous Apomorphine in the Treatment of Progressive Supranuclear Palsy and Cortico Basal Degeneration (APOPARKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Effects of subcutaneous apomorphine on quality of life
研究概览
简要总结
Treatment of tauopathies such as Progressive Supranuclear Palsy (PSP) and Cortico Basal Degeneration (CBD) remains a major challenge. These rare severe neurodegenerative extrapyramidal movement disorders share phenotypic overlap and are usually painful. Parkinson disease (PD) is a common extrapyramidal movement disorder and continuous subcutaneous apomorphine infusion (CSAI) is commonly used in advanced PD patients to alleviate motor and non-motor fluctuations. Effects of subcutaneous apomorphine were investigated especially on pain and, on quality of life in 7 patients with PSD or CBD.This is an observational "real life" surveillance-based study.The Verbal Rating Scale for Pain (VRS) was used to assess changes in pain level and the clinical global impression-improvement scale (CGI-I) was used to assess changes in patient's illness before and during six months of treatment. Detailed report of the symptoms and side effects has been recorded by home nurses throughout the study period.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PSP or CBD patients for whom a treatment with subcutaneaous apomorphine is indicated
排除标准
- •Pregnant or breastfeeding women
- •Patient under a legal protection procedure
- •Patient denying to participated to the study
- •Lack of affiliation to a social security system
结局指标
主要结局
Effects of subcutaneous apomorphine on quality of life
时间窗: 6 months
The clinical global impression-improvement scale (CGI-I) was used to assess changes in patient's illness. The CGI-I is a 7 point scale that assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment." CGI-I scale was assess before and during six months of treatment.
Effects of subcutaneous apomorphine on pain
时间窗: 6 months
The Verbal Rating Scale for Pain (VRS) was used to assess changes in pain level. The VRS is a five-point scale and consists of a list of adjectives describing various levels of symptom intensity: 0= no itch, 1= mild itch, 2= moderate itch , 3= severe itch and 4=very severe itch. It is used to categorize the itch intensity and features high reliability and concurrent validity. VRS scale was assess before and during six months of treatment.
次要结局
未报告次要终点