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

This study has been completed.
Information provided by (Responsible Party):
Boehringer Ingelheim Identifier:
First received: September 28, 2007
Last updated: October 31, 2013
Last verified: October 2013
  • 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)

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change in HADS subscores (anxiety and depression) from baseline [ Time Frame: 9-16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline pattern of patient rated symptom list (HADS) [ Time Frame: 9-16 weeks ] [ Designated as safety issue: No ]
  • Correlation of the change in UPDRS Part I and UPDRS Part III at the final visit [ Time Frame: 9-16 weeks ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: 9-16 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
PD patients

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®.
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Please refer to this study by its identifier: NCT00539214

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Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim Identifier: NCT00539214     History of Changes
Other Study ID Numbers: 248.639 
Study First Received: September 28, 2007
Last Updated: October 31, 2013
Health Authority: Germany: BfArM (Bundesinstitut für Arzneimittel und Medizinalprodukte

Additional relevant MeSH terms:
Parkinson Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases
Parkinsonian Disorders
Anti-Dyskinesia Agents
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses processed this record on February 07, 2016