Clinical trial NCT00617019: Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 3234
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parkinson's patients treated with various medications

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


Eligibility 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:

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: The occurrence of a past (since onset of PD) ICD
timeFrame: 6 months
measure: Demographic and medical history measures
timeFrame: up to 14 days after Visit 1
measure: Scores on psychiatric/neuropsychological instruments/tests
timeFrame: up to 14 days after Visit 1
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: 248.619.01034 Neurological Physicians of Arizona
state: Arizona
city: Scottsdale
country: United States
facility: 248.619.01007 Mayo Clinic - Scottsdale
state: Arizona
city: Sun City
country: United States
facility: 248.619.01025 Sun Health Research Institute
state: Arizona
city: Fresno
country: United States
facility: 248.619.01018 Margolin Brain Institute
state: California
city: Oxnard
country: United States
facility: 248.619.01031 Pacific Neuroscience Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: 248.619.01016 San Francisco VA PD Research, Education, & Clinical Center
state: California
city: Sunnyvale
country: United States
facility: 248.619.01023 The Parkinson's Institute
state: California
city: Englewood
country: United States
facility: 248.619.01021 Boehringer Ingelheim Investigational Site
state: Colorado
city: Danbury
country: United States
facility: 248.619.01027 Associated Neurologists, P.C.
state: Connecticut
city: New Haven
country: United States
facility: 248.619.01013 Molecular NeuroImaging
state: Connecticut
city: Boca Raton
country: United States
facility: 248.619.01020 Parkinson's Disease and Movement Disorders of Boca Raton
state: Florida
city: Gainesville
country: United States
facility: 248.619.01009 University of Florida
state: Florida
city: Atlanta
country: United States
facility: 248.619.01035 Emory University
state: Georgia
city: Augusta
country: United States
facility: 248.619.01006 Medical College of Georgia
state: Georgia
city: Chicago
country: United States
facility: 248.619.01014 Northwestern University
state: Illinois
city: Kansas City
country: United States
facility: 248.619.01001 The University of Kansas Medical Center
state: Kansas
city: Baltimore
country: United States
facility: 248.619.01015 John Hopkins Hospital
state: Maryland
city: Southfield
country: United States
facility: 248.619.01029 Clinical Neuroscience Center
state: Michigan
city: Minneapolis
country: United States
facility: 248.619.01022 University of Minnesota
state: Minnesota
city: Piscataway
country: United States
facility: 248.619.01008 Robert Wood Johnson Medical School
state: New Jersey
city: Albany
country: United States
facility: 248.619.01030 Parkinson's Disease and Movement Disorders Center
state: New York
city: Commack
country: United States
facility: 248.619.01036 Parkinson's Disease and Mov. Disorders Center of Long Island
state: New York
city: New York
country: United States
facility: 248.619.01017 Weill Cornell medical College
state: New York
city: Durham
country: United States
facility: 248.619.01003 Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: 248.619.01028 The Cleveland Clinic Foundation
state: Ohio
city: Allentown
country: United States
facility: 248.619.01004 Lehigh Valley Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: 248.619.01010 Parkinson's Disease research, Education and Clinical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: 248.619.01011 University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: 248.619.01024 Thomas Jefferson Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 248.619.01019 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Upland
country: United States
facility: 248.619.01012 Parkinson's Disease and Movement Disorders Center
state: Pennsylvania
city: Warwick
country: United States
facility: 248.619.01005 NeuroHealth
state: Rhode Island
city: Nashville
country: United States
facility: 248.619.01033 Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: 248.619.01032 Neurology Spclst of Dallas, PA
state: Texas
city: Houston
country: United States
facility: 248.619.01002 Baylor College of Medicine
state: Texas
city: Richmond
country: United States
facility: 248.619.01026 Neurology/Southeast Parkinson's Disease
state: Virginia
city: Calgary
country: Canada
facility: 248.619.02011 University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: 248.619.02010 The Glenrose Rehab. Hospital
state: Alberta
city: Winnipeg
country: Canada
facility: 248.619.02009 Movement Disorder Clinic
state: Manitoba
city: St. John's
country: Canada
facility: 248.619.02005 Health Sciences Centre
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: 248.619.02019 Dr. David King
state: Nova Scotia
city: Kitchener
country: Canada
facility: 248.619.02013
state: Ontario
city: London
country: Canada
facility: 248.619.02018 London HSC - University Hospital
state: Ontario
city: Markham
country: Canada
facility: 248.619.02001 Centre for Movement Discorder
state: Ontario
city: Ottawa
country: Canada
facility: 248.619.02008 Ottawa Civic Hospital
state: Ontario
city: Toronto
country: Canada
facility: 248.619.02016 The Toronto Western Hospital
state: Ontario
city: Montreal
country: Canada
facility: 248.619.02003 Unite des Troubles du Mouvement
state: Quebec
city: Saskatoon
country: Canada
facility: 248.619.02017 Royal University Hospital
state: Saskatchewan
city: Quebec
country: Canada
facility: 248.619.02002 Memory and Motor Skills Disorders Clinic
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Weintraub D, Koester J, Potenza MN, Siderowf AD, Stacy M, Voon V, Whetteckey J, Wunderlich GR, Lang AE. Impulse control disorders in Parkinson disease: a cross-sectional study of 3090 patients. Arch Neurol. 2010 May;67(5):589-95. doi: 10.1001/archneurol.2010.65.