The PRESTO (Parkinson's Rasagiline: Efficacy and Safety in the Treatment of Off) study evaluated rasagiline as an adjunct in PD patients with motor fluctuations on levodopa (96). In this study, 472 PD patients with at least 2.5 hours of daily off time were randomized to rasagiline 0.5 mg/day, 1 mg/day, or placebo. Primary outcome was the change in off time as measured by patients' home diaries from baseline to 26 weeks. Mean adjusted off time improved with each treatment—rasagiline 1 mg/day (1.85 hours), rasagiline 0.5 mg/day (1.41 hours), and placebo (0.91 hours). Compared with placebo, the differences were significant for both rasagiline 1 mg/day (P < 0.001) and rasagiline 0.5 mg/day (P = 0.02). There was a small but significant increase in on time with troublesome dyskinesia in the rasagiline 1 mg group (P = 0.03). The secondary endpoints of UPDRS ADL "off," motor UPDRS "on," and clinical global impression were all significantly improved with both dosages of rasagiline, and 1 mg/day rasagiline was also associated with significant improvement on the Schwab and England scale during off time.
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