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news.Newron Pharmaceuticals and Merck Serono have concluded patient recruitment in Settle Phase III double-blind, randomized, placebo-controlled trial to investigate safinamide in patients with advanced Parkinson's disease.
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The companies have recruited around 549 patients in the trial.
It enrolled 549 patients with mid- to late-stage idiopathic Parkinson’s disease (more than three years of disease duration) treated with a stable dose of levodopa for at least four weeks, who have motor fluctuations with more than one and a half hours of "OFF" time during the day.
The trial aims to investigate the efficacy and safety of a dose range of safinamide (50-100mg once daily), as an adjunctive therapy to a stable dose of levodopa.
Under an agreement signed between Merck Serono and Newron in 2006, Merck has exclusive rights for manufacturing, developing and commercializing afinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications.