Parkinson DiseaseNCT00617019
Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study)
An observational study of Parkinson Disease, run by Boehringer Ingelheim at 49 sites in 2 countries.
Trial summary
The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 3,234 participants
- Where
- 49 sitesin 2 countries
- Study dates
- Sep 2006to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's patients treated with various medications
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
49 sites in 2 countries.
49 sites in 2 countries
United States36 sites
248.619.01030 Parkinson's Disease and Movement Disorders Center
Albany, New York
248.619.01004 Lehigh Valley Hospital
Allentown, Pennsylvania
248.619.01035 Emory University
Atlanta, Georgia
248.619.01006 Medical College of Georgia
Augusta, Georgia
248.619.01015 John Hopkins Hospital
Baltimore, Maryland
248.619.01020 Parkinson's Disease and Movement Disorders of Boca Raton
Boca Raton, Florida
248.619.01014 Northwestern University
Chicago, Illinois
248.619.01028 The Cleveland Clinic Foundation
Cleveland, Ohio
248.619.01036 Parkinson's Disease and Mov. Disorders Center of Long Island
Commack, New York
248.619.01032 Neurology Spclst of Dallas, PA
Dallas, Texas
248.619.01027 Associated Neurologists, P.C.
Danbury, Connecticut
248.619.01003 Duke University Medical Center
Durham, North Carolina
248.619.01021 Boehringer Ingelheim Investigational Site
Englewood, Colorado
248.619.01018 Margolin Brain Institute
Fresno, California
248.619.01009 University of Florida
Gainesville, Florida
248.619.01034 Neurological Physicians of Arizona
Gilbert, Arizona
248.619.01002 Baylor College of Medicine
Houston, Texas
248.619.01001 The University of Kansas Medical Center
Kansas City, Kansas
248.619.01022 University of Minnesota
Minneapolis, Minnesota
248.619.01033 Vanderbilt University Medical Center
Nashville, Tennessee
248.619.01013 Molecular NeuroImaging
New Haven, Connecticut
248.619.01017 Weill Cornell medical College
New York, New York
248.619.01031 Pacific Neuroscience Medical Group, Inc.
Oxnard, California
248.619.01010 Parkinson's Disease research, Education and Clinical Center
Philadelphia, Pennsylvania
248.619.01011 University of Pennsylvania
Philadelphia, Pennsylvania
248.619.01024 Thomas Jefferson Hospital
Philadelphia, Pennsylvania
248.619.01008 Robert Wood Johnson Medical School
Piscataway, New Jersey
248.619.01019 Boehringer Ingelheim Investigational Site
Pittsburgh, Pennsylvania
248.619.01026 Neurology/Southeast Parkinson's Disease
Richmond, Virginia
248.619.01016 San Francisco VA PD Research, Education, & Clinical Center
San Francisco, California
248.619.01007 Mayo Clinic - Scottsdale
Scottsdale, Arizona
248.619.01029 Clinical Neuroscience Center
Southfield, Michigan
248.619.01025 Sun Health Research Institute
Sun City, Arizona
248.619.01023 The Parkinson's Institute
Sunnyvale, California
248.619.01012 Parkinson's Disease and Movement Disorders Center
Upland, Pennsylvania
248.619.01005 NeuroHealth
Warwick, Rhode Island
Canada13 sites
248.619.02011 University of Calgary
Calgary, Alberta
248.619.02010 The Glenrose Rehab. Hospital
Edmonton, Alberta
248.619.02019 Dr. David King
Halifax, Nova Scotia
248.619.02013
Kitchener, Ontario
248.619.02018 London HSC - University Hospital
London, Ontario
248.619.02001 Centre for Movement Discorder
Markham, Ontario
248.619.02003 Unite des Troubles du Mouvement
Montreal, Quebec
248.619.02008 Ottawa Civic Hospital
Ottawa, Ontario
248.619.02002 Memory and Motor Skills Disorders Clinic
Québec, Quebec
248.619.02017 Royal University Hospital
Saskatoon, Saskatchewan
248.619.02005 Health Sciences Centre
St. John's, Newfoundland and Labrador
248.619.02016 The Toronto Western Hospital
Toronto, Ontario
248.619.02009 Movement Disorder Clinic
Winnipeg, Manitoba
About this 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)
The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications.
- Conditions
- Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's patients | Observational study to compare rates of impulse control disorders in patients taking different medications for Parkinson's Disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
The occurrence of a past (since onset of PD) ICD
Measured: 6 months
Demographic and medical history measures
Measured: up to 14 days after Visit 1
Scores on psychiatric/neuropsychological instruments/tests
Measured: up to 14 days after Visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2008 (estimated)
- Study startSep 2006
- Primary completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 3,234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617019
- Sponsor's protocol ID
- 248.619
- Other IDs
- DOMINION
- Status last verified
- Nov 2013
- First submitted
- 5 Feb 2008
- Last updated
- 13 Nov 2013
- Results posted
- No
Publications
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.
PubMed 20457959
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00617019
- Acronym / sponsor ID
- 248.619
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,234 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Jan 2008 (actual)
- First posted
- 15 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's patients | – | –Observational study to compare rates of impulse control disorders in patients taking different medications for Parkinson's Disease |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients treated with various medications
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
The occurrence of a past (since onset of PD) ICD
Time frame: 6 months
Demographic and medical history measures
Time frame: up to 14 days after Visit 1
Scores on psychiatric/neuropsychological instruments/tests
Time frame: up to 14 days after Visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
- Derived from this study: PubMed 20457959Weintraub 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
49 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Boehringer Ingelheim at 49 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00617019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.