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From the Department of Neurological Sciences (Dr. Shannon), Rush Medical College, Rush-Presbyterian-St. Luke's Medical Center, Chicago, IL; Department of Neurology (Dr. Bennett), University of Virginia, Charlottesville, VA; and Department of Neurology (Dr. Friedman), Brown University, Providence, RI.
Address correspondence and reprint requests to Dr. Kathleen M. Shannon, Rush Medical College, Department of Neurological Sciences, Rush-Presbyterian-St. Luke's Medical Center, 1725 W. Harrison Street, Chicago, IL 60612.
A total of 335 patients with early Parkinson's disease (PD) were enrolled in a multicenter, randomized, double-blind trial designed to assess the efficacy and safety of pramipexole. Entry was restricted to patients with idiopathic PD who were not receiving levodopa. Pramipexole was administered according to an ascending dose schedule up to 4.5 mg/d. During the 7-week dose-escalation phase, each subject was titrated to his or her maximally tolerated dose of study medication. This was followed by a 24-week period of maintenance therapy. The mean daily dose during the maintenance period was 3.8 mg. Pramipexole significantly reduced the severity of PD symptoms and signs compared with placebo, as measured by decreases in parts II (Activities of Daily Living) and III (Motor Examination) of the Unified Parkinson's Disease Rating Scale at week 24 compared with baseline (p 
0.0001). Differences between the active drug and placebo groups emerged at week 3 (1.5 mg/d) in the ascending-dose interval and persisted throughout the maintenance phase (p 0.0001). The majority of patients completed the study (pramipexole 83%, placebo 80%). In the assessment of adverse events, nausea, insomnia, constipation, somnolence, and visual hallucinations occurred more frequently in the pramipexole treatment group compared with placebo patients. No clinically significant changes were noted in blood pressure or pulse rate. Overall, these results indicate that pramipexole is safe and effective in the treatment of early PD.
See Appendix for members of the Pramipexole Study Group.
Received February 24, 1997. Accepted in final form May 8, 1997.
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