Merck & Newron start Phase III safinamide trial

PRLog (Press Release) – Dec 06, 2007 – Merck KGaA’s Merck Serono division and Newron Pharmaceuticals (Milan, Italy) have launched a Phase III trial of safinamide as an add-on to dopamine agonist therapy in early Parkinson’s disease. The MOTION study will evaluate the efficacy and safety of two dose regimens of safinamide as an add-on to a single dopamine agonist, compared with dopamine agonist monotherapy.

The six-month, randomised, double-blind, international trial will involve some 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 randomised to receive safinamide 50 mg or 100 mg, or placebo, once daily as an adjunctive treatment.

The primary endpoint is the change in motor symptoms assessed by the change in the unified Parkinson’s disease rating scale 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.

Merck Serono has exclusive worldwide rights to develop, manufacture and commercialise safinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications, under an agreement signed with Newron in 2006. Safinamide is an alpha-aminoamide derivative believed to have a novel dual mechanism of action based on enhancing dopaminergic function and reducing glutamatergic activity by inhibiting glutamate release. Article submitted by www.jobs4dd.com - for latest news and jobs in the clinical research and drug development industries.