FDAnews
www.fdanews.com/articles/68818-agilect-improved-parkinson-s-symptoms-in-levodopa-treated-patients

Agilect Improved Parkinson's Symptoms in Levodopa-Treated Patients

February 16, 2005

Patients with moderate-to-advanced Parkinson's disease (PD) experiencing motor complications who added once-daily Agilect to their treatment with optimized levodopa with or without stable doses of other anti-PD medications experienced a significant improvement in their PD symptoms and a significant reduction in "off" time, according to the PRESTO study published in the February issue of Archives of Neurology.

Agilect (rasagiline tablets) was dosed once-daily and required no titration. The multicenter, randomized, placebo-controlled, double-blind, parallel group "Parkinson's Rasagiline: Efficacy and Safety in the Treatment of 'Off'" (PRESTO) study included 472 PD patients who were experiencing at least 2.5 hours of daily "off" time despite optimized treatment with levodopa with or without stable doses of other anti-PD medications at 57 PSG sites in the U.S. and Canada.

Many patients enrolled were treated, in addition to levodopa, with dopamine agonists, entacapone and/or anticholinergic medications. Patients received 1 mg or 0.5 mg Agilect or placebo once daily. The average reduction in "off" time among patients using Agilect was 1.85 hours daily for the 1-mg group and 1.41 hours daily in the 0.5-mg group, while placebo provided a reduction of 0.91 hours daily.