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Completed

NCT Number: NCT00539214

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

* 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)

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boehringer Ingelheim, Aalen, Germany

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About this study

Study Design:

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease

    Time frame: 9-16 weeks

  2. Change in sum scores of UPDRS Part III (motor examination) from baseline and UPDRS Part I (mentation, behavior and mood) from baseline

    Time frame: 9-16 weeks

  3. Change in HADS subscores (anxiety and depression) from baseline

    Time frame: 9-16 weeks

Secondary outcomes

  1. Baseline pattern of patient rated symptom list (HADS)

    Time frame: 9-16 weeks

  2. Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit

    Time frame: 9-16 weeks

  3. Frequency of adverse events

    Time frame: 9-16 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
First posted
Oct 4, 2007
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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