Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study)

This study has been completed.
Sponsor:
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00617019
First received: February 5, 2008
Last updated: November 11, 2013
Last verified: November 2013
  Purpose

The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications.


Condition
Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: A Cross-sectional, Retrospective Screening and Case-control Study Examining the Frequency of, and Risk Factors Associated With, Impulse Control Disorders in Parkinson's Disease Patients Treated With MIRAPEX® (Pramipexole) and Other Anti-parkinson Agents (DOMINION Study)

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Occurrence of current ImpulseControl Disorder(ICD) assessed via + res. of Modif.Massachusetts Gambling Screen,Modif.Minnesota Impulsive Disorder Interview for Sexuality,Modif.MIDI for Compulsive Buying,DSM-IV binge-eating research criteria questionnaire [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of a past (since onset of PD) ICD [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Demographic and medical history measures [ Time Frame: up to 14 days after Visit 1 ] [ Designated as safety issue: No ]
  • Scores on psychiatric/neuropsychological instruments/tests [ Time Frame: up to 14 days after Visit 1 ] [ Designated as safety issue: No ]

Enrollment: 3234
Study Start Date: September 2006
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
Parkinson's patients
Observational study to compare rates of impulse control disorders in patients taking different medications for Parkinson's Disease

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parkinson's patients treated with various medications

Criteria

Inclusion Criteria:

Observation Criteria:

Male or female outpatients, aged 30 to 75 years of age, with idiopathic PD. Patients must be selected on the basis of a prospective recruitment plan documented at the site, with the objective of obtaining an unbiased representative sample.

Patients must have been treated with anti-parkinson medication for a period of one year or greater and demonstrated a treatment response, in the opinion of the Investigator.

Patients must be willing and able to comply with study procedures. Patients must be willing and able to give meaningful, written informed consent. This must be completed prior to beginning any study procedures, in accordance with GCP and local legislation.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617019

  Show 49 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00617019     History of Changes
Other Study ID Numbers: 248.619, DOMINION
Study First Received: February 5, 2008
Last Updated: November 11, 2013
Health Authority: Canada:
United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on April 17, 2014