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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00539214
First Posted: October 4, 2007
Last Update Posted: November 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Boehringer Ingelheim
  Purpose
  • 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)

Condition
Parkinson Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Improvement of depressive symptoms (UPDRS item 3, HADS-D) compared to baseline in early and advanced Parkinsons's disease [ Time Frame: 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 [ Time Frame: 9-16 weeks ]
  • Change in HADS subscores (anxiety and depression) from baseline [ Time Frame: 9-16 weeks ]

Secondary Outcome Measures:
  • Baseline pattern of patient rated symptom list (HADS) [ Time Frame: 9-16 weeks ]
  • Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit [ Time Frame: 9-16 weeks ]
  • Frequency of adverse events [ Time Frame: 9-16 weeks ]

Enrollment: 1192
Study Start Date: March 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:
Study Design:
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD patients
Criteria

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®.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00539214


  Show 317 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00539214     History of Changes
Other Study ID Numbers: 248.639
First Submitted: September 28, 2007
First Posted: October 4, 2007
Last Update Posted: November 1, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents