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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00617019 |
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Date of registration:
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05/02/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Impulse Control Disorders in Parkinson's Patients Treated With Pramipexole and Other Agents (DOMINION Study)
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Scientific title:
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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) |
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Date of first enrolment:
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September 2006 |
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Target sample size:
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3234 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00617019 |
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Study type:
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Observational |
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Study design:
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Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional
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Phase:
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N/A
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Countries of recruitment
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Canada
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United States
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Contacts
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Name:
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Boehringer Ingelheim |
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Address:
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Telephone:
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Email:
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Affiliation:
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Boehringer Ingelheim |
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Key inclusion & exclusion criteria
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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:
Age minimum:
30 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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The occurrence of a past (since onset of PD) ICD
[Time Frame: 6 months]
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Demographic and medical history measures
[Time Frame: up to 14 days after Visit 1]
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Scores on psychiatric/neuropsychological instruments/tests
[Time Frame: up to 14 days after Visit 1]
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Secondary ID(s)
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DOMINION
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248.619
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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