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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: February 15, 2008
Last Update Posted: November 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Boehringer Ingelheim
The purpose is to explore the frequency of impulse control disorders in Parkinson's patients treated with different Parkinson's medications.

Parkinson Disease

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
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)

Resource links provided by NLM:

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 3234
Study Start Date: September 2006
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Parkinson's patients
Observational study to compare rates of impulse control disorders in patients taking different medications for Parkinson's Disease


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's patients treated with various medications

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00617019

  Show 49 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00617019     History of Changes
Other Study ID Numbers: 248.619
First Submitted: February 5, 2008
First Posted: February 15, 2008
Last Update Posted: November 13, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Parkinson Disease
Disruptive, Impulse Control, and Conduct Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents