Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease
- Registration Number
- NCT02248181
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to document pramipexole dosing during monotherapy, occurrence of fluctuations and dyskinesias, dose increases after deterioration of Parkinson's disease (PD) symptoms, assessment of the reasons for add-on treatment with L-Dopa and dosing of pramipexole and L-Dopa when given concomitantly.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 442
Inclusion Criteria
- Diagnosis of early stage idiopathic Parkinson's Disease
- No pre-treatment with any dopaminergic treatment (de novo patients), or Pre-treatment with L-Dopa at doses of < 200 mg/d
Exclusion Criteria
- Treating physicians are asked to consider the regulation described in the Summary of Product Characteristics (SmPC) for the treatment with pramipexole
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Idiopathic PD patients Pramipexole -
- Primary Outcome Measures
Name Time Method Change in dosing details of Pramipexole up to 21 months Occurrence and clinical course of Parkinson Disease (PD) motor symptoms up to 21 months
- Secondary Outcome Measures
Name Time Method Assessment of Kinetic Tremor up to 21 months Spiral test with at least five rotations from the centre to the edge in blinded fashion
Change in dosing details of L-Dopa up to 21 months Global Assessment of tolerability by investigator on 4-point scale after 21 months Global assessment of efficacy by investigator on a 4-point scale after 21 months Number of patients with adverse drug reactions up to 21 months