PIRLONG-PD Safety and Efficacy of Piribedil in Parkinson's Disease During Long Term Therapy
- Registration Number
- NCT01519856
- Lead Sponsor
- Desitin Arzneimittel GmbH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 908
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description tablet piribedil (Clarium) -
- Primary Outcome Measures
Name Time Method Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease 4 years
- Secondary Outcome Measures
Name Time Method Quality of life parameters 4 years Influence on quality of life 4 years
Trial Locations
- Locations (1)
Dr. Erich Scholz
🇩🇪Boeblingen, Baden-Wuertemberg, Germany