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Merck Serono's Safinamide Significantly Improved Motor Function in Patients With Advanced Parkinson's Disease in a Phase III Pivotal Trial
Date:2/3/2009

d Kirschbaum, Merck Serono's Executive Vice President for Global Research and Development. "These results represent a further step toward our goal to provide patients and doctors with urgently needed new treatment possibilities in the Neurodegenerative Diseases therapeutic area."

Dr Ravi Anand, Newron's Chief Medical Officer, said: "These results are extremely encouraging. In addition to increasing "ON" time and reducing total "OFF" time, as well as "OFF" time after morning dose in patients with mid- to late-stage Parkinson's disease receiving optimized treatment with drugs including levodopa, dopamine agonists, COMT inhibitors, anti-cholinergics and amantidine, the results indicate a statistically significant improvement of motor function. Previously reported results from Phase II and Phase III studies have shown improvement of motor symptoms in early Parkinson's disease patients on dopamine agonist monotherapy. These results from both early and advanced Parkinson's disease patients underline safinamide's potential to be used as adjunctive therapy along the continuum of Parkinson's disease."

This Phase III study was a six-month (24-week), randomized, double-blind, placebo-controlled international trial. It enrolled 669 patients with mid- to late-stage idiopathic Parkinson's disease (more than three years of disease duration) receiving stable doses of levodopa, who had motor fluctuations with >1.5 hours of "OFF" time(1) during the day. Additionally, patients may have received concomitant treatment with stable doses of a dopamine agonist and/or an anti-cholinergic drug. After a four-week levodopa dosage stabilization phase, study participants were randomized to one of the three arms of the trial (1:1:1) to receive either one of two different doses of safinamide (50 or 100 mg once daily: 223 and 224 patients, respectively) or matching placebo tablets (222 patients), as adjunctive treatment to their levodopa therap
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SOURCE Merck Serono
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