CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 286 enrolled
Drug / intervention
Pramipexole immediate releasedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00651183
NCT00651183N/ACompleted

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

Boehringer Ingelheim·observational·Posted Apr 2, 2008·Updated May 20, 2014

In Brief

An observational study evaluating Pramipexole immediate release for Parkinson Disease. Completed, enrolled 286 participants across 57 sites.

Detailed 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).

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2, 2008
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Posted 18.3 years ago

Interventions

Pramipexole immediate releasedrug