Double‐blind, randomized, controlled trial of rasagiline as monotherapy in early Parkinson's disease patients

Abstract

Rasagiline (N‐propargyl‐1(R)‐aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase‐B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel‐group, double‐blind, randomized, placebo‐controlled, 10‐week study. Fifty‐six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3‐week dose‐escalation period was followed by a 7‐week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were −1.8 (±1.3), −3.6 (±1.7), −3.6 (±1.2), and −0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline‐treated and placebo‐treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD. © 2004 Movement Disorder Society