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www.fdanews.com/articles/69808-agilect-improves-parkinson-s-symptoms-in-levodopa-treated-patients

Agilect Improves Parkinson's Symptoms in Levodopa-Treated Patients

March 14, 2005

Patients with Parkinson's disease (PD), who were optimized on levodopa therapy and other PD therapies, experienced a significant reduction in the duration of "off" time, as well as an improvement in motor symptom control during both "on" and "off" periods when once-daily Agilect was added to their treatment regimens.

The positive effects seen with once-daily Agilect (rasagiline tablets) were similar to those seen in patients treated with entacapone, given with each levodopa dose, when compared to placebo. The results of the LARGO study (Lasting effect in Adjunct therapy with Rasagiline Given Once daily) will be published in the March 12 issue of The Lancet.

The LARGO study was a multicenter, 18-week randomized, placebo-controlled, double-blind, parallel trial implemented at 74 sites in Europe, Israel and Argentina. The study included 687 PD patients with a clinical diagnosis of idiopathic PD, who were experiencing motor fluctuations despite receiving optimized levodopa therapy with or without stable doses of other additional anti-PD drugs, including dopamine agonists and anticholinergic agents.

Patients receiving either Agilect or entacapone in addition to levodopa had similar significant reductions from baseline in average total "off" time of 1.2 hours compared with a 0.4 hour reduction in "off" time with placebo. Treatment also resulted in an increase in "on" time, the majority of which was without troublesome dyskinesia (a distortion or impairment of voluntary movement that interferes with daily activities).