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

November 11, 2013 updated by: Boehringer Ingelheim

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)

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

3234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada
        • 248.619.02002 Memory and Motor Skills Disorders Clinic
    • Alberta
      • Calgary, Alberta, Canada
        • 248.619.02011 University of Calgary
      • Edmonton, Alberta, Canada
        • 248.619.02010 The Glenrose Rehab. Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada
        • 248.619.02009 Movement Disorder Clinic
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • 248.619.02005 Health Sciences Centre
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
        • 248.619.02019 Dr. David King
    • Ontario
      • Kitchener, Ontario, Canada
        • 248.619.02013
      • London, Ontario, Canada
        • 248.619.02018 London HSC - University Hospital
      • Markham, Ontario, Canada
        • 248.619.02001 Centre for Movement Discorder
      • Ottawa, Ontario, Canada
        • 248.619.02008 Ottawa Civic Hospital
      • Toronto, Ontario, Canada
        • 248.619.02016 The Toronto Western Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • 248.619.02003 Unite des Troubles du Mouvement
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • 248.619.02017 Royal University Hospital
  • United States
    • Arizona
      • Gilbert, Arizona, United States
        • 248.619.01034 Neurological Physicians of Arizona
      • Scottsdale, Arizona, United States
        • 248.619.01007 Mayo Clinic - Scottsdale
      • Sun City, Arizona, United States
        • 248.619.01025 Sun Health Research Institute
    • California
      • Fresno, California, United States
        • 248.619.01018 Margolin Brain Institute
      • Oxnard, California, United States
        • 248.619.01031 Pacific Neuroscience Medical Group, Inc.
      • San Francisco, California, United States
        • 248.619.01016 San Francisco VA PD Research, Education, & Clinical Center
      • Sunnyvale, California, United States
        • 248.619.01023 The Parkinson's Institute
    • Colorado
      • Englewood, Colorado, United States
        • 248.619.01021 Boehringer Ingelheim Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States
        • 248.619.01027 Associated Neurologists, P.C.
      • New Haven, Connecticut, United States
        • 248.619.01013 Molecular NeuroImaging
    • Florida
      • Boca Raton, Florida, United States
        • 248.619.01020 Parkinson's Disease and Movement Disorders of Boca Raton
      • Gainesville, Florida, United States
        • 248.619.01009 University of Florida
    • Georgia
      • Atlanta, Georgia, United States
        • 248.619.01035 Emory University
      • Augusta, Georgia, United States
        • 248.619.01006 Medical College of Georgia
    • Illinois
      • Chicago, Illinois, United States
        • 248.619.01014 Northwestern University
    • Kansas
      • Kansas City, Kansas, United States
        • 248.619.01001 The University of Kansas Medical Center
    • Maryland
      • Baltimore, Maryland, United States
        • 248.619.01015 John Hopkins Hospital
    • Michigan
      • Southfield, Michigan, United States
        • 248.619.01029 Clinical Neuroscience Center
    • Minnesota
      • Minneapolis, Minnesota, United States
        • 248.619.01022 University of Minnesota
    • New Jersey
      • Piscataway, New Jersey, United States
        • 248.619.01008 Robert Wood Johnson Medical School
    • New York
      • Albany, New York, United States
        • 248.619.01030 Parkinson's Disease and Movement Disorders Center
      • Commack, New York, United States
        • 248.619.01036 Parkinson's Disease and Mov. Disorders Center of Long Island
      • New York, New York, United States
        • 248.619.01017 Weill Cornell medical College
    • North Carolina
      • Durham, North Carolina, United States
        • 248.619.01003 Duke University Medical Center
    • Ohio
      • Cleveland, Ohio, United States
        • 248.619.01028 The Cleveland Clinic Foundation
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • 248.619.01004 Lehigh Valley Hospital
      • Philadelphia, Pennsylvania, United States
        • 248.619.01010 Parkinson's Disease research, Education and Clinical Center
      • Philadelphia, Pennsylvania, United States
        • 248.619.01011 University of Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • 248.619.01024 Thomas Jefferson Hospital
      • Pittsburgh, Pennsylvania, United States
        • 248.619.01019 Boehringer Ingelheim Investigational Site
      • Upland, Pennsylvania, United States
        • 248.619.01012 Parkinson's Disease and Movement Disorders Center
    • Rhode Island
      • Warwick, Rhode Island, United States
        • 248.619.01005 NeuroHealth
    • Tennessee
      • Nashville, Tennessee, United States
        • 248.619.01033 Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States
        • 248.619.01032 Neurology Spclst of Dallas, PA
      • Houston, Texas, United States
        • 248.619.01002 Baylor College of Medicine
    • Virginia
      • Richmond, Virginia, United States
        • 248.619.01026 Neurology/Southeast Parkinson's Disease

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Parkinson's patients treated with various medications

Description

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:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Parkinson's patients
Observational study to compare rates of impulse control disorders in patients taking different medications for Parkinson's Disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of a past (since onset of PD) ICD
Time Frame: 6 months
6 months
Demographic and medical history measures
Time Frame: up to 14 days after Visit 1
up to 14 days after Visit 1
Scores on psychiatric/neuropsychological instruments/tests
Time Frame: up to 14 days after Visit 1
up to 14 days after Visit 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

February 5, 2008

First Submitted That Met QC Criteria

February 14, 2008

First Posted (Estimate)

February 15, 2008

Study Record Updates

Last Update Posted (Estimate)

November 13, 2013

Last Update Submitted That Met QC Criteria

November 11, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.619
  • DOMINION

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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