Enrollment occurred from March 13, 2007, to May 28, 2010. Eligible participants were fewer than 5 years from Parkinson disease diagnosis (defined as asymmetric features including bradykinesia plus resting tremor, rigidity, or both) and had taken levodopa or a dopamine agonist for at least 90 days but not longer than 2 years. Continuation of other prescribed Parkinson disease therapy was allowed. Participants were to be followed up for a minimum of 5 years or until the end of the trial (a maximum of 8 years for the first enrolled participants) and encouraged to remain in the study even if they discontinued study drug. Adjustments of Parkinson disease medication were permitted during the trial. The institutional review board(s) approved the study, the study protocol, and the informed consent process and documentation. All patients provided written informed consent.
Protocol detail
Early Parkinson's Disease Intervention
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Bradykinesia
Diagnosis
Dopamine agonist
Institutional review board
Levodopa
Medication
Parkinson disease
Patients
Resting tremor
Rigidity
Therapy
Corresponding Organization :
Other organizations : University of Rochester, The University of Texas Health Science Center at Houston, Medical University of South Carolina, National Institutes of Health, University of South Florida, Pacific Health Research and Education Institute, University of California, San Francisco, SUNY Downstate Health Sciences University, State University of New York, University of Vermont, University of Kentucky, University of Michigan–Ann Arbor, University of Maryland, Baltimore, Philadelphia University, University of Pennsylvania, University of Calgary, The University of Texas Southwestern Medical Center, University of Southern California, Ochsner Medical Center, University of Colorado Denver, Parkinson's Institute and Clinical Center, Johns Hopkins University, Georgia Regents Medical Center, Augusta University, Thomas Jefferson University, Rush University Medical Center, Beth Israel Deaconess Medical Center, Northwestern University, University of Miami, Brigham and Women's Hospital
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Variable analysis
independent variables
- Duration of Parkinson disease diagnosis (fewer than 5 years)
- Duration of levodopa or dopamine agonist use (at least 90 days but not longer than 2 years)
- Participant outcomes during the follow-up period (minimum of 5 years or up to 8 years)
- Continuation of other prescribed Parkinson disease therapy
- Adjustments of Parkinson disease medication during the trial
- Positive control: Participants were required to have taken levodopa or a dopamine agonist for at least 90 days but not longer than 2 years.
- Negative control: Not explicitly mentioned.
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