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

Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00539214

Enrollment

1192

Registered

2007-10-04

Start date

2007-03-31

Completion date

Unknown

Last updated

2013-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Disease

Brief summary

* 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)

Detailed description

Study Design:

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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®.

Design outcomes

Primary

Measure	Time frame
Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease	9-16 weeks
Change in sum scores of UPDRS Part III (motor examination) from baseline and UPDRS Part I (mentation, behavior and mood) from baseline	9-16 weeks
Change in HADS subscores (anxiety and depression) from baseline	9-16 weeks

Secondary

Measure	Time frame
Baseline pattern of patient rated symptom list (HADS)	9-16 weeks
Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit	9-16 weeks
Frequency of adverse events	9-16 weeks

Countries

Germany

Outcome results