Post Marketing Surveillance Study of Sifrol® in Patients With Idiopathic Parkinson's Disease

Boehringer Ingelheim442 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

442

Conditions

Parkinson Disease

Interventions

PramipexoleDRUG

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in dosing details of Pramipexole

Time frame: up to 21 months

Occurrence and clinical course of Parkinson Disease (PD) motor symptoms

Time frame: up to 21 months

Secondary Outcomes

Assessment of Kinetic Tremor

Spiral test with at least five rotations from the centre to the edge in blinded fashion

Time frame: up to 21 months

Change in dosing details of L-Dopa

Time frame: up to 21 months

Global Assessment of tolerability by investigator on 4-point scale

Time frame: after 21 months

Global assessment of efficacy by investigator on a 4-point scale

Time frame: after 21 months

Number of patients with adverse drug reactions

Time frame: up to 21 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.