SEDPARK1: Safety and Efficacy Study With the Non-ergot Dopamine-agonist Piribedil in Parkinson's Disease
Completed
- Conditions
- Parkinson's Disease
- Registration Number
- NCT00725478
- Lead Sponsor
- Desitin Arzneimittel GmbH
- Brief Summary
The aim of the non-interventional Post Marketing Study is to investigate the use of the non-ergot dopamine agonist piribedil (trade name: CLARIUM) in mono- and combination therapy in patients with Morbus Parkinson. Tolerability and course of the disease or change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonists will be documented under routine conditions. Piribedil should be prescribed according to its marketing authorisation by the responsible neurologist.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 250
Inclusion Criteria
- Male and female patients 18 years and older.
- Indication: Morbus Parkinson.
- Treatment with piribedil for the first time.
- Monotherapy with piribedil.
- Combination therapy with L-Dopa (from the beginning or secondary) and/or in combination with other antiparkinsonian drugs.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method to monitor use in real practice including adverse events on piribedil 3 months
- Secondary Outcome Measures
Name Time Method Efficacy 3 months