临床试验/NCT02248181

NCT02248181已完成不适用

Post Marketing Surveillance Study of Sifrol® - Monotherapy in Patients With Idiopathic Parkinson's Disease

Boehringer Ingelheim0 个研究点目标入组 442 人开始时间: 2004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: 442
主要终点: Change in dosing details of Pramipexole

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 document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.

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

•Diagnosis of early stage idiopathic Parkinson's Disease
•No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d

排除标准

•Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole

研究组 & 干预措施

Idiopathic PD patients

干预措施: Pramipexole (Drug)

结局指标

主要结局

Change in dosing details of Pramipexole

时间窗: up to 21 months

Occurrence and clinical course of Parkinson Disease (PD) motor symptoms

时间窗: up to 21 months

次要结局

Assessment of Kinetic Tremor(up to 21 months)
Change in dosing details of L-Dopa(up to 21 months)
Global Assessment of tolerability by investigator on 4-point scale(after 21 months)
Global assessment of efficacy by investigator on a 4-point scale(after 21 months)
Number of patients with adverse drug reactions(up to 21 months)

研究者

发起方

Boehringer Ingelheim

申办方类型

Industry

责任方

Sponsor

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