Efficacy and Safety of Long-term Therapy With Piribedil (CLARIUM) in Patients With M. Parkinson Under Consideration of Quality of Life Parameters and Cognitive Function
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 908
- 试验地点
- 1
- 主要终点
- Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease
研究概览
简要总结
Non-Ergot Dopamine agonists are meanwhile the drugs of first-choice in the treatment of Parkinson's disease. The receptor profile of the non-ergot dopamine-agonist piribedil is unique. In addition to agonistic effects on dopaminergic D2- and D3-receptors piribedil has adrenergic alpha-2A- and alpha-2C-receptors antagonisic properties. There is evidence from the literature that the antagonistic properties of piribedil are correlated with an improvement of cognitive function and vigilance parameters in parkinson's disease. The aim of the present non-interventional study is to investigate the safety and efficacy of piribedil during long-term therapy of patients with M. Parkinson under consideration of cognitive functions and quality of life.
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
- •newly diagnosed or advanced idiopathic Parkinson's disease
- •male and female patients over 18 years of age
- •indication for treatment with piribedil according to Summary of Product Characteristics (SmPC)
排除标准
- •in line with piribedil SmPC
- •in particular hypersensitivity to piribedil or to any of the excipients and pregnancy and lactation as stated in the SmPC
研究组 & 干预措施
tablet
干预措施: piribedil (Clarium) (Drug)
结局指标
主要结局
Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease
时间窗: 4 years
次要结局
- Quality of life parameters(4 years)
- Influence on quality of life(4 years)