Non-interventional Observational Study With Pramipexole: Impact on Non-motor Symptoms in Parkinson's Disease

Boehringer Ingelheim

Status: Completed

Conditions: Parkinson Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT00539214

248.639

Details and patient eligibility

About

• To compare the effect of pramipexole on depressive symptoms in early and advanced PD patients
• To evaluate the course of depressive symptoms measured with UPDRS Part I (mentation, behavior and mood) and with HADS-D under pramipexole treatment
• To investigate whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III)

Full description

Study Design:

Enrollment: 1,192 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Idiopathic Parkinsons disease with or without fluctuations
2. Indication for treatment with Sifrol®
3. Male or female patients of age
4. Presence of at least mild depressive symptoms (as judged by the treating physician)
5. Ability to reliably complete a self-rating scale (HADS)

Exclusion criteria

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Sifrol®.