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Promising Data on Cognitive Effects of Safinamide in Early,Parkinson's Disease

70 early stage Parkinson’s disease patients (less than 5 years of disease) treated with a stable dose of a single dopamine agonist for at least 4 weeks were randomized to one of the three arms of the study to receive either safinamide at a dose of 50 to 100 mg once daily (90 patients), or safinamide at a dose of 150 to 200 mg once daily (90 patients) or matching placebo tablets (90 patients), as an add-on treatment to dopamine agonist therapy.

Trial data were presented last month at the American Academy of Neurology 59th Annual Meeting in Boston, Massachusetts, USA.
The data demonstrated that the addition of safinamide to a stable dose of a single dopamine agonist in study 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 (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 ± 7.2 in the safinamide-treated group versus minus 3.6 ± 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 ± 3.8 in the safinamide-treated group versus minus 1.2 ± 3.5 in the placebo group; p=0.0248; 95% CI=[-1.8;-0.1]).
The side effects observed in the safinamide group were similar to those observed in the placebo group.
The higher safinamide dose-range of 150 to 200 mg per day did not offer any incremental advantage over safinamide 50 to 100 mg per
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