Parkinson's Disease
Conditions
Keywords
open, non-intervention, observational
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.
Interventions
DRUGpiribedil (Clarium)
oral tablets, 50 mg
Sponsors
Desitin Arzneimittel GmbH
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event profile during long term therapy with piribedil in patients with Parkinson's disease | 4 years |
Secondary
| Measure | Time frame |
|---|---|
| Influence on quality of life | 4 years |
| Quality of life parameters | 4 years |
Countries
Germany
Outcome results
None listed