The 1.5-year study aims to test the efficacy of safinamide in increasing periods of good functioning compared with placebo. The study will also evaluate changes in cognitive function that have been shown to be improved by safinamide in a previous phase III trial in early Parkinsons disease patients treated with dopamine agonists." (Forbes 11/27/06)

Data presented at Movement Disorder Society’s 11th International Congress (June 2007) suggested that safinamide has an effect on cognitive performance in study patients with early Parkinson’s disease. (Newron press release)

18 month data was released in Aug 2007. When both dosage groups were combined, the study did not meet its endpoints. However the data "suggest that, at a dose of 50 to 100 mg once daily, safinamide may delay the time to intervention for therapeutic adjustment and provide sustained improvement of Parkinson's disease symptoms when added to dopamine agonist therapy...

Additional Phase III studies evaluating the lower dose-range either as add-on to dopamine agonist or as add-on to levodopa therapy are expected to be initiated in 2007 in early and mid-to-late stage Parkinson's disease respectively." (press release 8/22/07)

In Feb. 2008, Newron Pharmaceuticals announced it "received a written confirmation from the European Patent Office (EPO) that they intend to grant the patent “Methods for treatment of Parkinson’s Disease”. The application was filed by Newron in Europe and in all major countries in 2004. The patent relates to methods for treating Parkinson’s disease (PD) through the administration of Newron’s compound safinamide in combination with levodopa. ...The patent will protect the use of safinamide as add-on to levodopa up to 2024." (Newron press release 2/26/08)

Feb. 3, 2009 the sponsor announced the "first Phase III trial of investigational agent safinamide as adjunctive therapy to levodopa (study 016) met its primary endpoint by increasing daily "ON" time in mid- to late-stage Parkinson's disease patients with motor fluctuations by 1.3 hours. "ON" time represents periods when Parkinson's patients experience their best level of motor functioning."

May 7 2009, initiation of SETTLE, the Second Phase III Clinical Trial of Safinamide in Advanced Parkinson's Disease. (Newron Press Release) Additional Results from SETTLE First Phase III Study 016: The 100 mg dose was also shown to improve depressive symptoms. Concomitant Phase III trials are recruiting (outside U.S.) as MOTION, SETTLE, and Open Label Trial to Determine Long-Term Efficacy. (Clinicaltrials.gov August 15 2009)

"Under this IND, a protocol has been approved  to assess the safety of safinamide in 12 healthy volunteers. The trial will
be conducted at the University of Vienna, Austria. The FDA  approved study is being conducted to confirm that no dietary
restrictions are needed while being treated with safinamide." (Newron press release July 23, 2003)