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From the Department of Neuroscience and IRCCS Neuromed Pozzilli (IS) (Dr. Stocchi), Neurophysiopathology (Drs. Onofrj and Thomas), Movement Disorders Centre, Department of Neuroscience, Universita G. DAnnunzio, Chieti-Pescara, Pescara, Department of Neuroscience (Dr. Bonuccelli), Institute of Neurology, University of Pisa, and U.O.C. Neurology, Ospedale Versilia (LU), Kendle International Research Organization (Dr. Van Dijk), Saronno (VA), and Newron Pharmaceuticals (Drs. Cattaneo, Sala, and Fariello), Bresso (Milan), Italy; Department of Neurology (Dr. Arnold), Medical Faculty of the Charité, Humboldt University, Berlin, Germany; and Department of Neurology (Dr. Kwiecinski), Medical University of Warsaw, and Department of Neurology (Dr. Szczudlik), Collegium Medicum, Jagiellonian University, Krakow, Poland.
Address correspondence and reprint requests to Dr. R.G. Fariello, Newron Pharmaceuticals, Via L. Ariosto 21, Bresso (Milan) 20091, Italy; e-mail: ruggero.fariello{at}newron.com
A median safinamide (SAF) dose of 70 mg/day (range 40 to 90 mg/day) increased the percentage of parkinsonian patients improving their motor scores by
30% from baseline (responders) after 3 months from 21.4% (placebo) to 37.5% (p < 0.05, calculated by logistic regression analysis). In a subgroup of 101 patients under stable treatment with a single dopamine agonist, addition of SAF magnified the response (47.1% responders, mean 4.7-point motor score decrease; p
0.05). These results suggest that doses of SAF exerting ion channel block and glutamate release inhibition add to its symptomatic effect and warrant exploration of higher doses.
Received January 8, 2004. Accepted in final form April 3, 2004.
Drs. Stocchi, Arnold, Thomas, and Sala have received consultation fees from Newron Pharmaceuticals Spa; Drs. Cattaneo and Fariello are full-time employees of Newron; and Dr. Fariello holds equities in Newron in excess of $10,000.
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