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The PRESTO Study

Parkinson Study Group

Arch Neurol. 2005;62:241-248.

Background  Rasagiline (N-propargyl-1[R]-aminoindan) mesylate is a novel irreversible selective monoamine oxidase type B inhibitor, previously demonstrated to improve symptoms in early Parkinson disease (PD).

Objective  To determine the safety, tolerability, and efficacy of rasagiline in levodopa-treated patients with PD and motor fluctuations.

Design  Multicenter, randomized, placebo-controlled, double-blind, parallel-group study.

Patients  Parkinson disease patients (N = 472) with at least 21/2 hours of daily "off" (poor motor function) time, despite optimized treatment with other anti-PD medications.

Interventions  Rasagiline, 1.0 or 0.5 mg/d, or matching placebo.

Main Outcome Measures  Change from baseline in total daily off time measured by patients’ home diaries during 26 weeks of treatment, percentage of patients completing 26 weeks of treatment, and adverse event frequency.

Results  During the treatment period, the mean adjusted total daily off time decreased from baseline by 1.85 hours (29%) in patients treated with 1.0 mg/d of rasagiline, 1.41 hours (23%) with 0.5 mg/d rasagiline, and 0.91 hour (15%) with placebo. Compared with placebo, patients treated with 1.0 mg/d rasagiline had 0.94 hour less off time per day, and patients treated with 0.5 mg/d rasagiline had 0.49 hour less off time per day. Prespecified secondary end points also improved during rasagiline treatment, including scores on an investigator-rated clinical global impression scale and the Unified Parkinson’s Disease Rating Scale (activities of daily living in the off state and motor performance in the "on" state). Rasagiline was well tolerated.

Conclusions  Rasagiline improves motor fluctuations and PD symptoms in levodopa-treated PD patients. In light of recently reported benefits in patients with early illness, rasagiline is a promising new treatment for PD.

Group Information: A list of the members of the Parkinson Study Group who participated in this study and were authors of this report appears above.

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