临床试验/NCT02248142

NCT02248142已完成不适用

Sifrol® (Pramipexole) Impact on RLS: A 12-weeks Observational Study in Patients With Primary RLS

Boehringer Ingelheim0 个研究点目标入组 1,029 人开始时间: 2006年2月最近更新: 2014年9月25日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Boehringer Ingelheim
入组人数: 1,029
主要终点: Assessment of RLS symptoms (IRLS) on a 4-point rating scale

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)

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 planned to be initiated on treatment with pramipexole as part of the routine care could be included into the study
•Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pretreated with dopaminergic medication
•Male or female patients of any age

排除标准

•Treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SPC) 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

Assessment of RLS severity on a 6-point rating scale

时间窗: up to 12 weeks

次要结局

Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale(up to 12 weeks)
Number of patients with adverse events(up to 12 weeks)
Time to reach maintenance dose of pramipexole(up to 12 weeks)
Global assessment of efficacy by investigator on a 5-point scale(after 12 weeks)

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

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