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

NCT00617019 | Completed

• 2 other identifiers: 248.619DOMINION
• Study Type: observational
• Target: 3,234
• Locations: 2 countries
• Sites: 49

Brief Summary

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

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• The occurrence of a past (since onset of PD) ICD

  6 months

• Demographic and medical history measures

  up to 14 days after Visit 1

• Scores on psychiatric/neuropsychological instruments/tests

  up to 14 days after Visit 1

Study Arms (1)

Parkinson's patients

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

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's patients treated with various medications

You may qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (49)

248.619.01034 Neurological Physicians of Arizona

Gilbert, Arizona, United States

Location

248.619.01007 Mayo Clinic - Scottsdale

Scottsdale, Arizona, United States

Location

248.619.01025 Sun Health Research Institute

Sun City, Arizona, United States

Location

248.619.01018 Margolin Brain Institute

Fresno, California, United States

Location

248.619.01031 Pacific Neuroscience Medical Group, Inc.

Oxnard, California, United States

Location

248.619.01016 San Francisco VA PD Research, Education, & Clinical Center

San Francisco, California, United States

Location

248.619.01023 The Parkinson's Institute

Sunnyvale, California, United States

Location

248.619.01021 Boehringer Ingelheim Investigational Site

Englewood, Colorado, United States

Location

248.619.01027 Associated Neurologists, P.C.

Danbury, Connecticut, United States

Location

248.619.01013 Molecular NeuroImaging

New Haven, Connecticut, United States

Location

248.619.01020 Parkinson's Disease and Movement Disorders of Boca Raton

Boca Raton, Florida, United States

Location

248.619.01009 University of Florida

Gainesville, Florida, United States

Location

248.619.01035 Emory University

Atlanta, Georgia, United States

Location

248.619.01006 Medical College of Georgia

Augusta, Georgia, United States

Location

248.619.01014 Northwestern University

Chicago, Illinois, United States

Location

248.619.01001 The University of Kansas Medical Center

Kansas City, Kansas, United States

Location

248.619.01015 John Hopkins Hospital

Baltimore, Maryland, United States

Location

248.619.01029 Clinical Neuroscience Center

Southfield, Michigan, United States

Location

248.619.01022 University of Minnesota

Minneapolis, Minnesota, United States

Location

248.619.01008 Robert Wood Johnson Medical School

Piscataway, New Jersey, United States

Location

248.619.01030 Parkinson's Disease and Movement Disorders Center

Albany, New York, United States

Location

248.619.01036 Parkinson's Disease and Mov. Disorders Center of Long Island

Commack, New York, United States

Location

248.619.01017 Weill Cornell medical College

New York, New York, United States

Location

248.619.01003 Duke University Medical Center

Durham, North Carolina, United States

Location

248.619.01028 The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Location

248.619.01004 Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Location

248.619.01010 Parkinson's Disease research, Education and Clinical Center

Philadelphia, Pennsylvania, United States

Location

248.619.01011 University of Pennsylvania

Philadelphia, Pennsylvania, United States

Location

248.619.01024 Thomas Jefferson Hospital

Philadelphia, Pennsylvania, United States

Location

248.619.01019 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

248.619.01012 Parkinson's Disease and Movement Disorders Center

Upland, Pennsylvania, United States

Location

248.619.01005 NeuroHealth

Warwick, Rhode Island, United States

Location

248.619.01033 Vanderbilt University Medical Center

Nashville, Tennessee, United States

Location

248.619.01032 Neurology Spclst of Dallas, PA

Dallas, Texas, United States

Location

248.619.01002 Baylor College of Medicine

Houston, Texas, United States

Location

248.619.01026 Neurology/Southeast Parkinson's Disease

Richmond, Virginia, United States

Location

248.619.02011 University of Calgary

Calgary, Alberta, Canada

Location

248.619.02010 The Glenrose Rehab. Hospital

Edmonton, Alberta, Canada

Location

248.619.02009 Movement Disorder Clinic

Winnipeg, Manitoba, Canada

Location

248.619.02005 Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

Location

248.619.02019 Dr. David King

Halifax, Nova Scotia, Canada

Location

248.619.02013

Kitchener, Ontario, Canada

Location

248.619.02018 London HSC - University Hospital

London, Ontario, Canada

Location

248.619.02001 Centre for Movement Discorder

Markham, Ontario, Canada

Location

248.619.02008 Ottawa Civic Hospital

Ottawa, Ontario, Canada

Location

248.619.02016 The Toronto Western Hospital

Toronto, Ontario, Canada

Location

248.619.02003 Unite des Troubles du Mouvement

Montreal, Quebec, Canada

Location

248.619.02002 Memory and Motor Skills Disorders Clinic

Québec, Quebec, Canada

Location

248.619.02017 Royal University Hospital

Saskatoon, Saskatchewan, Canada

Location

Related Publications (1)

• 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.

  PMID: 20457959 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 5, 2008
• First Posted: February 15, 2008
• Study Start: September 1, 2006
• Primary Completion: January 1, 2008
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

US (36); CA (13)