NEWRON COMPLETES ENROLLMENT IN SAFINAMIDE TRIAL

Newron Pharmaceuticals has announced the completion of patient enrollment in its Phase III trial with Safinamide for the treatment of Parkinson's disease. A total of 260 patients in 26 centers worldwide have been randomized in the study, which aims to show the efficacy and safety of safinamide used as adjunctive treatment to a dopamine agonist in patients with early-stage Parkinson's disease.

The Phase III trial has been designed as a double-blind, placebo-controlled, parallel-group, randomized, multinational study during which patients will receive treatment for 18 months. Early-stage Parkinson's disease outpatients enrolled in the trial will receive a stable dose of a single dopamine agonist and, as an add-on therapy, one of two non-overlapping dose ranges of orally administered Safinamide or a placebo. Patients enrolled and completing an initial six-month of double-blind treatment will be eligible to enter a 12-month, double-blind continuation study. The continuation study will measure the time for which the effect of Safinamide is maintained in these patients.