Merck Serono initiates Phase III Parkinson’s disease study

Merck Serono, a division of Merck KGaA, and its partner Newron Pharmaceuticals, an Italian biopharmaceutical company, have initiated the Settle study, a six-month, randomized, double-blind, international Phase III trial that will evaluate the efficacy and safety of a dose range of safinamide as add-on therapy to a stable dose of levodopa, in mid- to late-stage Parkinson’s disease patients with motor fluctuations compared to placebo.

The trial 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.

Additionally, patients may be receiving concomitant treatment with stable doses of a dopamine agonist, a COMT inhibitor, an anticholinergic and/or amantadine. After a four-week levodopa dosage stabilization phase, study participants will be randomized in one of the two arms of the trial (1:1) to receive either safinamide or matching placebo tablets, as adjunctive treatment to levodopa therapy.

The primary endpoint of the trial is the change in daily ‘on’ time, as assessed by the recordings of diary cards maintained by patients after prior training, 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.

Bernhard Kirschbaum, Merck Serono’s head of global R&D, said: 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. 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.