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news.Merck has reported that its Merck Serono division and its partner Newron Pharmaceuticals have initiated the Motion study 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 in Parkinson's disease.
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The Motion study is a six-month (24-week), randomized, double-blind, international Phase III trial that will involve more than 650 patients with early idiopathic Parkinson’s disease (less than five years of disease duration) treated with a stable dose of a single dopamine agonist for at least four weeks.
Study participants will be randomized in one of the three arms of the trial (1:1:1), to receive either safinamide 50mg once daily, safinamide 100mg once daily or matching placebo tablets, as adjunctive treatment to dopamine agonist therapy.
The primary endpoint of the trial is the change in motor symptoms assessed by the change in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score from baseline to week 24. Secondary endpoints include changes in measures of activities of daily living, cognitive functions, global clinical status and health-related quality of life.
Safinamide, an alpha-aminoamide derivative that is orally administered, is currently being developed by Merck Serono and Newron as an add-on treatment for patients with Parkinson’s disease. Merck Serono 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.