Brief Summary

The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

286

participants targeted

Target at P75+ for all trials

Geographic Reach

1 country

57 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2008

Completed

1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed

1 day until next milestone

First Posted

Study publicly available on registry

April 2, 2008

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

March 3, 2010

Completed

Last Updated

May 20, 2014

Status Verified

May 1, 2014

First QC Date

March 31, 2008

Results QC Date

December 14, 2009

Last Update Submit

May 9, 2014

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (4)

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Change From Baseline in UPDRS Part III (Motor Examination)
14 components rating scale with 27 items scored by 0 (none) - 4 (severe)
Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)

Interventions

Pramipexole immediate releaseDRUG

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

PD patients

You may qualify if:

Idiopathic PD with or without fluctuations
Indication for treatment with Pramipexole
Presence of at least mild depressive symptoms (as judged by the treating physician)
Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))

You may not qualify if:

Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
Ongoing treatment with pramipexole

Contact the study team to confirm eligibility.