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

Boehringer Ingelheim

Status: Completed

Conditions: Parkinson Disease

Treatments: Drug: Pramipexole

Study type: Observational

Funder types: Industry

Identifiers

NCT02248181

248.539

Details and patient eligibility

About

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.

Enrollment: 442 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

442 participants in 1 patient group

Idiopathic PD patients

Treatment:

Drug: Pramipexole