NCT02248155已完成不适用
Sifrol® Onset of Action and Impact on RLS: A 12-week Observational Study in Patients With Primary RLS
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,644
- 主要终点
- Assessment of RLS symptoms (IRLS) on a 4-point rating scale
研究概览
简要总结
The objectives of this Post Marketing Surveillance (PMS) are:
- Evaluation of the treatment effect of pramipexole on Restless Legs Syndrome (RLS) severity as measured by International Restless Legs Syndrome Scale (IRLS) and Clinical Global Impression Improvement scale (CGI- I)
- Evaluation of the time to reaching maintenance dose of pramipexole
- Evaluation of work productivity impairment associated with RLS based on the Work Productivity and Activity Impairment Questionnaire (WPAI) questionnaire
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suffering from primary RLS who are eligible for Pramipexol (PPX) treatment could be included into the study
- •Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pre-treated with dopaminergic medication
- •Male of female patients of any age
排除标准
- •The treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
研究组 & 干预措施
RLS patients
干预措施: Pramipexole (Drug)
结局指标
主要结局
Assessment of RLS symptoms (IRLS) on a 4-point rating scale
时间窗: up to 12 weeks
Change from Baseline in WPAI by means of a patient questionnaire
时间窗: Baseline, 12 weeks
次要结局
- Time to reach pramipexol maintenance dose(up to 12 weeks)
- Number of patients with adverse drug reactions(up to 12 weeks)
- Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale(up to 12 weeks)
- Global assessment of efficacy by investigator on a 5-point scale(after 12 weeks)
研究者
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