Merck Serono S.A. has announced that Phase III data on safinamide, a new agent in Phase III development for the treatment of Parkinson's disease symptoms, were presented by Professor Fabrizio Stocchi at the American Academy of Neurology 59th Annual Meeting in Boston, Massachusetts, USA.
These data are from a 6-month (24 weeks), randomized, double blind, placebo-controlled, international trial.
"These data are promising for patients with Parkinson's disease," said Fabrizio Stocchi, Professor of Neurology and Honorary Consultant at the IRCCS San Raffaele Rome, University La Sapienza, and principal investigator of the study. "The data not only show the benefit of safinamide on motor symptoms and activities of daily living, but also indicate an effect on cognitive performance, which may represent a major advantage for the patient."
The data demonstrated that the addition of safinamide to a stable dose of a single dopamine agonist in patients with early stage Parkinson's disease resulted in a statistically significant improvement in motor symptoms, as measured by the Unified Parkinson's Disease Rating Scale(1) (UPDRS) Part III Motor Score (primary endpoint). After 24 weeks of treatment with safinamide at the dose of 50 to 100 mg once daily, the UPDRS Part III Motor Score was significantly improved over the effect of dopamine agonist monotherapy (difference between end of study and baseline of minus 6.0 plus or minus 7.2 in the safinamide-treated group versus minus 3.6 plus or minus 7.1 in the placebo group; p=0.0419; 95% CI=[-3.7;-0.1]).
In addition, treatment with safinamide at the dose of 50 to 100 mg once daily over a 24-week period resulted in a significant improvement of UPDRS Part II Activities of Daily Living Score, compared with dopamine agonist monotherapy (difference between end of study and baseline of minus 2.2 plus or minus 3.8 in the safinamide-treated group versus minus 1.2 plus or minus 3.5 in the placebo group; p=0.0248; 95% CI=[-1.8;-0.1]).
Safinamide was also studied for effects on cognition. Compared with patients on dopamine agonist monotherapy, the addition of safinamide was associated with an improvement in cognitive function as shown by an improvement in tests assessing spatial working memory, strategic target detection and auditory number sequencing.
The side effects observed in the safinamide group were similar to those observed in the placebo group.