Non-interventional Observational Study on the Influence of Pramipexole (PPX) on Sensory Symptoms of Restless Legs Syndrome (RLS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,504
- 试验地点
- 34
- 主要终点
- Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3
研究概览
简要总结
The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are:
- To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire.
- To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from Restless Legs Syndrome-6).
- To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores.
- To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3.
- To evaluate the development of behavioural changes under pramipexole treatment.
详细描述
Study Design:
研究设计
- 研究类型
- Observational
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3
时间窗: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner
时间窗: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist
时间窗: Baseline to Visit 3
Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.
次要结局
- Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3(Baseline to Visit 3)
- Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3(Baseline to Visit 3)
- Behavioural Changes During Treatment(Baseline to Visit 3)