Newron Pharmaceuticals and Merck Serono have concluded patient recruitment in an international, double-blind, randomized, placebo-controlled Phase III MOTION study.
In the study, the companies have randomized around 679 patients who are suffering from early-stage Parkinson’s disease.
The companies will assess the safety and efficacy of two dose regimens of safinamide (50 and 100mg once daily), as add-on therapy to a stable dose of a single dopamine agonist, in comparison to dopamine agonist monotherapy in the trial.
The trial’s primary endpoint is the change in motor symptoms evaluated by the change in the Unified Parkinson’s Disease Rating Scale (UPDRS) Part III score from baseline to week 24.
However, the secondary endpoints include changes in measures of activities of daily living, cognitive functions, global clinical status and health-related quality of life.
Newron chief medical officer Ravi Anand said it signifies that all of the phase III studies evaluating the efficacy and safety of safinamide in patients with early or late Parkinson’s disease are nearing completion.