A controlled, randomized, delayed-start study of rasagiline in early Parkinson disease.
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.


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


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


METHODS
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.


METHODS
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).


CONCLUSIONS
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.
D000203:Activities of Daily Living / Q000145:classification; D000368:Aged; D000978:Antiparkinson Agents / Q000008:administration & dosage* / Q000009:adverse effects; D015331:Cohort Studies; D004185:Disability Evaluation; D018450:Disease Progression; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007189:Indans / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D008996:Monoamine Oxidase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D010300:Parkinson Disease / Q000175:diagnosis / Q000188:drug therapy*
D000978:Antiparkinson Agents; D007189:Indans; D008996:Monoamine Oxidase Inhibitors; C031967:rasagiline