Merck Completes Patient Enrollment in MOTION, a Phase III Pivotal Clinical Trial of Safinamide in Early Parkinson’s Disease

Study will evaluate safety and efficacy of safinamide as add-on to dopamine agonist therapy in early Parkinson’s disease

01-Jul-2011 - Germany

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 pivotal trial is designed to evaluate the efficacy and safety of two dose regimens of safinamide (50 and 100 mg once daily), 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 MOTION Phase III trial in early stage Parkinson’s disease represents another step forward in our clinical development program of safinamide,” said Dr. Bernhard Kirschbaum, 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 MOTION study is part of the clinical development program of safinamide, together with completed studies 015, 016, 017 and 018, 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.

MOTION study design

The study is a six-month (24-week), randomized, double-blind, placebo-controlled international Phase III trial. It enrolled 679 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 were randomized in one of the three arms of the trial (1:1:1), to receive either safinamide 50 mg once daily, safinamide 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 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.

https://www.bionity.com/en/news/133311/merck-completes-patient-enrollment-in-motion-a-phase-iii-pivotal-clinical-trial-of-safinamide-in-early-parkinsons-disease.html