CEE PMSS (Central Eastern European Post-Marketing Surveillance Study) First Presentation of Mirapexin in Parkinson Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,448
- 试验地点
- 27
- 主要终点
- Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated
研究概览
简要总结
In this study information is gathered about the treatment of Parkinson patients who present themselves in a neurological practice for the first time
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
- •Parkinson Disease patients presenting to neurologist for first time
排除标准
- •Hypersensitivity to the active substance or to any of the excipients
结局指标
主要结局
Number of De-novo Patients in Whom Monotherapy With Mirapexin® Could be Successfully Initiated
时间窗: 4 - 8 weeks
Successful initiation was defined as a clinical assessment of efficacy by the neurologist rated at least as "good" on a 4 point scale after 4-8 weeks Mirapexin® treatment, where:1 = very good; 2 = good; 3 = moderate; and 4 = poor. De-novo patients were identified by: those who were referred: - if 'Reason for Referral' = 'initiation of therapy' or for 'diagnostic reason' and for those not referred: - if initial pharmacotherapy = 'Mirapexin® monotherapy' (i.e., no other anti Parkinson Disease (PD) therapy)
次要结局
- Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I(Baseline and 4 to 8 weeks)
- Change From Baseline in UPDRS Part III(Baseline and 4 - 8 weeks)
- Global Clinical Assessments of Efficacy of Mirapexin® for All Patients(4 - 8 weeks)