Merck Serono Begins Phase III Parkinson’s Study

Merck Serono and partner Newron Pharmaceuticals SpA have initiated the SETTLE study to evaluate the efficacy and safety of a dose range of safinamide (50-100 mg once daily) as an add-on therapy to levodopa, in mid- to late-stage Parkinson’s disease patients.

The SETTLE study is one of the Phase III trials for a development program designed to support an application for marketing authorization. SETTLE is a six-month, randomized, double-blind, placebo-controlled trial that includes more than 450 patients with Parkinson’s disease treated with levodopa for at least four weeks whose motor fluctuations have more than one and a half hours of “OFF” time during the day. After a four-week levodopa dosage stabilization phase, study participants will be randomized in one of the two arms of the trial to receive either safinamide or placebo, as adjunctive treatment to levodopa therapy.

The primary endpoint is the change in daily “ON” time, as assessed by patient diaries, from baseline to week 24. Secondary endpoints include changes in measures of activities of daily living, global clinical status and health-related quality of life.

“Managing motor fluctuations and reducing the time during which anti-Parkinson drugs are not working and symptoms return, the so-called ‘OFF’ times, are still unmet medical needs for patients with mid- to late-stage Parkinson’s disease,” said Bernhard Kirschbaum, Merck Serono’s head of Global R&D. “After the encouraging results we obtained for study 016, we aim to confirm the efficacy of safinamide as an add-on therapy to levodopa in a flexible dosing regimen.”