SEDPARK2: Post Marketing Surveillance to Observe Safety and Efficacy of Piribedil in Parkinson's Disease (PIR-002/K)
- Registration Number
- NCT00727727
- Lead Sponsor
- Desitin Arzneimittel GmbH
- Brief Summary
The objective of the Post Marketing Surveillance 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. Neurologists in private practices in Germany should document the safety and course of the disease/change of parkinsonian symptoms during stabilisation on, or change over from other dopamine agonist treatment under routine conditions. Piribedil should be prescribed according to its marketing authorisation.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
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 in combination with other antiparkinsonian drugs).
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Parkinsonian patients Piribedil -
- Primary Outcome Measures
Name Time Method to monitor use in daily routine practice including adverse events 3 months
- Secondary Outcome Measures
Name Time Method to monitor use in daily routine practice including efficacy aspects 3 months
Trial Locations
- Locations (1)
Medical Practice for Neurology
🇩🇪Wedel, Germany