Parkinson Disease Clinical Trial
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)
| Verified date | November 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada:United States: Food and Drug Administration |
| Study type | Observational |
The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications.
| Status | Completed |
| Enrollment | 3234 |
| Est. completion date | |
| Est. primary completion date | January 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 30 Years to 75 Years |
| Eligibility |
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: |
Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Canada | 248.619.02011 University of Calgary | Calgary | Alberta |
| Canada | 248.619.02010 The Glenrose Rehab. Hospital | Edmonton | Alberta |
| Canada | 248.619.02019 Dr. David King | Halifax | Nova Scotia |
| Canada | 248.619.02013 | Kitchener | Ontario |
| Canada | 248.619.02018 London HSC - University Hospital | London | Ontario |
| Canada | 248.619.02001 Centre for Movement Discorder | Markham | Ontario |
| Canada | 248.619.02003 Unite des Troubles du Mouvement | Montreal | Quebec |
| Canada | 248.619.02008 Ottawa Civic Hospital | Ottawa | Ontario |
| Canada | 248.619.02002 Memory and Motor Skills Disorders Clinic | Quebec | |
| Canada | 248.619.02017 Royal University Hospital | Saskatoon | Saskatchewan |
| Canada | 248.619.02005 Health Sciences Centre | St. John's | Newfoundland and Labrador |
| Canada | 248.619.02016 The Toronto Western Hospital | Toronto | Ontario |
| Canada | 248.619.02009 Movement Disorder Clinic | Winnipeg | Manitoba |
| United States | 248.619.01030 Parkinson's Disease and Movement Disorders Center | Albany | New York |
| United States | 248.619.01004 Lehigh Valley Hospital | Allentown | Pennsylvania |
| United States | 248.619.01035 Emory University | Atlanta | Georgia |
| United States | 248.619.01006 Medical College of Georgia | Augusta | Georgia |
| United States | 248.619.01015 John Hopkins Hospital | Baltimore | Maryland |
| United States | 248.619.01020 Parkinson's Disease and Movement Disorders of Boca Raton | Boca Raton | Florida |
| United States | 248.619.01014 Northwestern University | Chicago | Illinois |
| United States | 248.619.01028 The Cleveland Clinic Foundation | Cleveland | Ohio |
| United States | 248.619.01036 Parkinson's Disease and Mov. Disorders Center of Long Island | Commack | New York |
| United States | 248.619.01032 Neurology Spclst of Dallas, PA | Dallas | Texas |
| United States | 248.619.01027 Associated Neurologists, P.C. | Danbury | Connecticut |
| United States | 248.619.01003 Duke University Medical Center | Durham | North Carolina |
| United States | 248.619.01021 Boehringer Ingelheim Investigational Site | Englewood | Colorado |
| United States | 248.619.01018 Margolin Brain Institute | Fresno | California |
| United States | 248.619.01009 University of Florida | Gainesville | Florida |
| United States | 248.619.01034 Neurological Physicians of Arizona | Gilbert | Arizona |
| United States | 248.619.01002 Baylor College of Medicine | Houston | Texas |
| United States | 248.619.01001 The University of Kansas Medical Center | Kansas City | Kansas |
| United States | 248.619.01022 University of Minnesota | Minneapolis | Minnesota |
| United States | 248.619.01033 Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | 248.619.01013 Molecular NeuroImaging | New Haven | Connecticut |
| United States | 248.619.01017 Weill Cornell medical College | New York | New York |
| United States | 248.619.01031 Pacific Neuroscience Medical Group, Inc. | Oxnard | California |
| 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 | Philadelphia | Pennsylvania |
| United States | 248.619.01008 Robert Wood Johnson Medical School | Piscataway | New Jersey |
| United States | 248.619.01019 Boehringer Ingelheim Investigational Site | Pittsburgh | Pennsylvania |
| United States | 248.619.01026 Neurology/Southeast Parkinson's Disease | Richmond | Virginia |
| United States | 248.619.01016 San Francisco VA PD Research, Education, & Clinical Center | San Francisco | California |
| United States | 248.619.01007 Mayo Clinic - Scottsdale | Scottsdale | Arizona |
| United States | 248.619.01029 Clinical Neuroscience Center | Southfield | Michigan |
| United States | 248.619.01025 Sun Health Research Institute | Sun City | Arizona |
| United States | 248.619.01023 The Parkinson's Institute | Sunnyvale | California |
| United States | 248.619.01012 Parkinson's Disease and Movement Disorders Center | Upland | Pennsylvania |
| United States | 248.619.01005 NeuroHealth | Warwick | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 6 months | No | |
| Secondary | The occurrence of a past (since onset of PD) ICD | 6 months | No | |
| Secondary | Demographic and medical history measures | up to 14 days after Visit 1 | No | |
| Secondary | Scores on psychiatric/neuropsychological instruments/tests | up to 14 days after Visit 1 | No |
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