Similar results were achieved in LARGO, a second, large, placebo-controlled clinical trial.3†
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* The recommended initial dose as adjunct therapy is 0.5 mg administered once daily. If a sufficient clinical response is not achieved, the dose may be increased to 1 mg administered once daily.
† Results of 2 multicenter, randomized, multinational trials conducted in Parkinson’s disease patients treated chronically with stable doses of levodopa and experiencing motor fluctuations including, but not limited to, “end of dose wearing off” and “sudden or random off.” In both trials the primary measure of effectiveness was the change from baseline to the end of the treatment period in the mean number of daytime “off” hours. In PRESTO, conducted by the Parkinson Study Group, a total of 472 subjects were randomized and treated for 26 weeks. In LARGO, a total of 687 subjects were randomized to treatment and treated for 18 weeks and included a COMT-inhibitor treatment group (N=227).2,3
REFERENCES
1. AZILECT® Prescribing Information.
2. The Parkinson Study Group. A randomized placebo-controlled trial of rasagiline in levodopa-treated patients with Parkinson disease and motor fluctuations. The PRESTO study. Arch Neurol. 2005;62:241-248.
3. Rascol O, Brooks DJ, Melamed E, et al. Rasagiline as an adjunct to levodopa in patients with Parkinson’s disease and motor fluctuations (LARGO, Lasting effect in Adjunct therapy with Rasagiline Given Once daily, study): a randomised, double-blind, parallel-group trial. Lancet. 2005;365(9463):947-954.