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The TEMPO Study

Parkinson Study Group

Arch Neurol. 2002;59:1937-1943.

Context  Monotherapy with rasagiline mesylate may be useful in early Parkinson disease (PD).

Objective  To evaluate the safety and efficacy of the selective monoamine oxidase type B inhibitor rasagiline.

Design  Multicenter, 26-week, parallel-group, randomized, double-blind, placebo-controlled clinical trial.

Setting  Academically based movement disorders clinics.

Patients  Patients with early PD not requiring dopaminergic therapy (n = 404).

Intervention  Research participants were randomized to rasagiline mesylate at dosages of 1 mg or 2 mg per day or matching placebo. A 1-week escalation period was followed by a 25-week maintenance period.

Main Outcome Measure  The primary prespecified measure of efficacy was the change in the total Unified Parkinson's Disease Rating Scale score between baseline and 26 weeks of treatment, comparing each active treatment group with the placebo group.

Results  Monotherapy with rasagiline was effective in this 26-week study. The adjusted effect size for the total Unified Parkinson's Disease Rating Scale was -4.20 units comparing 1 mg of rasagiline and placebo (95% confidence interval, -5.66 to -2.73 units; P<.001) and -3.56 units comparing a 2-mg dosage and placebo (95% confidence interval, -5.04 to -2.08 units; P<.001). There were no meaningful differences in the frequency of adverse events or premature withdrawals among the treatment groups.

Conclusions  Rasagiline is effective as monotherapy for patients with early PD. The 2 dosages in this trial were both effective relative to placebo. Further study is warranted to evaluate the longer-term effects of rasagiline in PD.

This study was supported by Teva Pharmaceutical Industries, Ltd.

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