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Clinical Trials/NCT00617019
NCT00617019CompletedNot Applicable

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)

Boehringer Ingelheim49 sites in 2 countries3,234 target enrollmentStarted: September 2006Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
3,234
Locations
49
Primary Endpoint
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
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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

Study Design

Study Type
Observational
Observational Model
Ecologic Or Community
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
30 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry

Study Sites (49)

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