Merck Serono, Newron Start Parkinson's Disease Study

Merck Serono, a division of Merck KGaA, and Italy’s Newron Pharmaceuticals have started the MOTION study to evaluate the efficacy and safety of once-daily safinamide as add-on therapy to a dopamine agonist versus dopamine agonist monotherapy.

The six-month, randomized, double-blind, international Phase III trial will involve more than 650 patients with early idiopathic Parkinson’s disease. Participants will receive safinamide 50 or 100 mg 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 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, Merck Serono said.

Merck Serono has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications under a 2006 agreement with Newron.