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Title: Rasagiline Shows Potential Against Early Parkinson's Disease

URL: http://archneur.ama-assn.org/cgi/content/abstract/59/12/1937

Archives of Neurology 2002;59(12):1937-1943. "A Controlled Trial of Rasagiline in Early Parkinson Disease: The TEMPO Study"
01/03/2003 10:01:14 AM
By David Loshak

The novel, non-vasoactive selective monoamine oxidase type B inhibitor rasagiline shows promise as neuroprotective first-line monotherapy in early Parkinson's disease. According to the phase III Rasagiline as Early Monotherapy for Parkinson's Patients (TEMPO) study, rasagiline is both safe and effective, report investigators based at the University of Pennsylvania. This multicentre, 26-week, parallel-group, randomised, double-blind, placebo-controlled clinical trial involved 404 patients aged at least 35 years with early Parkinson's disease not requiring dopaminergic therapy. Patients were randomised to receive rasagiline 1.0 mg/day or 2.0 mg/day or matching placebo. A one-week escalation period was followed by 25 weeks of maintenance therapy. The primary measure of efficacy was change in the total Unified Parkinson's Disease Rating Scale score between baseline and 26 weeks with each active treatment compared against placebo. The adjusted effect size for the total Unified Parkinson's Disease Rating Scale was -4.20 units with rasagiline 1.0 mg/day compared to placebo, and -3.56 units with rasagiline 2.0 mg/day compared to placebo (p<.001 for each comparison). There were no meaningful differences between the treatment groups in the frequency of adverse events or premature withdrawals. The investigators say further study is warranted to determine rasagiline's long-term effects and of its potential to attenuate the progression of Parkinson's disease. This study was supported by Teva Pharmaceutical Industries, Ltd.

http://archneur.ama-assn.org/cgi/content/abstract/59/12/1937

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