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 enrollmentSeptember 2006

ConditionsParkinson Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Boehringer Ingelheim
Enrollment: 3234
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
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

September 2006

End Date

January 2008

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Boehringer Ingelheim

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

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)