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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00539214
First received: September 28, 2007
Last updated: October 31, 2013
Last verified: October 2013
  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 ] [ 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:

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00539214

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

Additional Information:
No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov 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
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
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 28, 2014