The Second Phase III Clinical Trial of Safinamide is underway for sufferers of Advanced Parkinson’s Disease
Newron Pharmaceuticals, a research and development company focused on novel CNS and pain therapies, and its partner Merck Serono announced today the initiation of the SETTLE1 study. This study will evaluate the efficacy and safety of a dose range of safinamide (50-100 mg once daily) 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 SETTLE study is one of the Phase III trials that constitute the clinical development program designed to support an application for marketing authorization as discussed with regulatory authorities. SETTLE is a six-month (24-week), randomized, double-blind, international Phase III trial. The trial will involve more than 450 patients with mid-to-late stage idiopathic Parkinson’s disease (over 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”2 time during the day. Additionally, patients may be receiving associated 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 objective of the trial is ascertaining 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.
“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 Research and Development. “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.”
Copyright Press Association 2009