Merck KGaA and its partner Newron Pharmaceuticals S.p.A. announced that patient enrollment has been completed in the MOTION1 study.
This randomized, double-blind, placebo-controlled, international Phase III trial is designed to evaluate the efficacy and safety of two dose regimens of safinamide as add-on therapy to a stable dose of a single dopamine agonist, compared with dopamine agonist monotherapy. A total of 679 patients with early-stage Parkinson’s disease have been randomized in the study.
“The completion of enrollment into the Motion1 Phase III trial in early stageParkinson’s disease represents another step forward in our clinical development program of safinamide,” says Bernhard Kirschbaum, MD, head of global research and development of the Merck Serono division. “Our goal is to provide a new treatment option to patients with Parkinson’s disease, a neurodegenerative disease with a high remaining unmet medical need.”
The Motion1study is part of the clinical development program of safinamide as well as the ongoing SETTLE study. This clinical program is designed to investigate safinamide as an add-on therapy to dopamine agonist therapy in patients with early Parkinson’s disease and as an add-on to levodopa therapy in patients with advanced Parkinson’s disease.
Merck has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications, as per the agreement signed with Newron in 2006.
Release Date: June 29, 2011
Filed Under: Drug Discovery