Merck Completes Patient Enrollment in SETTLE, a Phase III Pivotal Clinical Trial of Safinamide in Advanced Parkinson’s Disease
Study will evaluate efficacy and safety of safinamide as add-on therapy to a stable dose of levodopa
Merck KGaA announced , that its Merck Serono division and partner Newron Pharmaceuticals S.p.A. completed patient enrollment in the SETTLE1 study. This randomized, double-blind, placebo-controlled, international phase III pivotal trial is designed to evaluate the efficacy and safety of a dose range of safinamide (50 – 100 mg once daily), as an adjunctive therapy to a stable dose of levodopa. A total of 549 patients with mid- to late-stage Parkinson’s disease with motor fluctuations were randomized in the study.
The SETTLE study is part of the clinical development program of safinamide in Parkinson’s disease, together with completed studies 015, 016, 017 and 018, as well as the ongoing MOTION study. This clinical program is designed to investigate safinamide as an add-on therapy to dopamine agonist therapy in patients with early Parkinson’s disease and as an add-on to levodopa therapy in patients with advanced Parkinson’s disease.
Merck Serono has exclusive worldwide rights to develop, manufacture and commercialize safinamide in Parkinson’s disease, Alzheimer’s disease and other therapeutic applications, as per the agreement signed with Newron in 2006.
1 SETTLE: SafinamidE Treatment as add-on To LEvodopa in idiopathic Parkinson’s disease with motor fluctuations.
SETTLE study design
The study is a six-month (24-week), randomized, double-blind, placebo-controlled international Phase III trial. It enrolled 549 patients with mid- to late-stage idiopathic Parkinson’s disease (more than three 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 were randomized in one of the two arms of the trial (1:1) to receive either safinamide or matching placebo tablets, as adjunctive treatment.
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.
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