Safinamide enters Ph III SETTLE trial

Germany's Merck KGaA and Italian drugmaker Newron Pharmaceuticals have initiated the SETTLE study, a late-stage trial that will evaluate the  efficacy and safety of a dose range of safinamide (50mg to 100mg once  daily) as add-on therapy to levodopa, in mid- to late-stage Parkinson's  disease patients with motor fluctuations.

The SETTLE study is one of the Phase III trials in the drug's  development program. The six-month, randomized, double-blind  investigation will involve more than 450 patients with mid- to  late-stage idiopathic Parkinson's disease (more than five years of  disease duration) treated with a stable dose of levodopa for at least  four weeks who have motor fluctuations with more than one and a half  hours of off time during the day.