Parkinson Disease
Conditions
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.
Interventions
DRUGPramipexole
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Global Assessment of tolerability by investigator on 4-point scale | after 21 months | — |
| Assessment of Kinetic Tremor | up to 21 months | Spiral test with at least five rotations from the centre to the edge in blinded fashion |
| Number of patients with adverse drug reactions | up to 21 months | — |
| Global assessment of efficacy by investigator on a 4-point scale | after 21 months | — |
| Change in dosing details of L-Dopa | up to 21 months | — |
Outcome results
None listed