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

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT00539214
• Lead Sponsor: Boehringer Ingelheim

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:

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-09-28
• Study First Submitted QC: 2007-10-02
• Study First Posted: 2007-10-04
• Primary Completion: 2007-12
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-31
• Last Update Posted: 2013-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1192

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Boehringer Ingelheim; 🇩🇪 Hellenthal, Germany