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Parkinson Study Group

Arch Neurol. 2004;61:561-566.

Background  Treatment with rasagiline mesylate, an irreversible monoamine oxidase type B inhibitor, improves symptoms of early Parkinson disease (PD). Preclinical studies suggest that this compound may also modify the progression of PD.

Objective  To compare the effects of early and later initiation of rasagiline on progression of disability in patients with PD.

Design  Double-blind, parallel-group, randomized, delayed-start clinical trial.

Settings and Patients  Four hundred four subjects with early PD, not requiring dopaminergic therapy, enrolled at 32 sites in the United States and Canada.

Interventions  Subjects were randomized to receive rasagiline, 1 or 2 mg/d, for 1 year or placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months.

Main Outcome Measure  Change in total Unified Parkinson's Disease Rating Scale score from baseline to 12 months.

Results  Three hundred seventy-one subjects were included in the 1-year efficacy analysis. Subjects treated with rasagiline, 2 mg/d, for 1 year had a 2.29-unit smaller increase in mean adjusted total Unified Parkinson's Disease Rating Scale score compared with subjects treated with placebo for 6 months followed by rasagiline, 2 mg/d, for 6 months (P = .01). The mean adjusted difference between the placebo/rasagiline, 2 mg/d, group and those receiving rasagiline, 1 mg/d, for 1 year was –1.82 unit on the Unified Parkinson's Disease Rating Scale score (P = .05).

Conclusion  Subjects treated with rasagiline, 2 and 1 mg/d, for 12 months showed less functional decline than subjects whose treatment was delayed for 6 months.

A list of the Parkinson Study Group TEMPO investigators was published previously (Arch Neurol. 2002;59:1937-1943).

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