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Safinamide Improves Motor Function in Parkinson's Disease

Safinamide improves motor function in early Parkinson's disease, a multicenter group of researchers report.

"Safinamide is a novel experimental neuroprotectant combining several properties of potential benefit in Parkinson's disease," Dr. R. G. Fariello, of Newron Pharmaceuticals, Milan, Italy, and colleagues write in the August 24th issue of Neurology. In a placebo-controlled trial, the team examined whether safinamide improves symptoms in moderately severe Parkinson's disease.

Following a 10- to 24-day run-in period, a 12-week treatment period began. Patients were randomly assigned to receive placebo, safinamide 0.5 mg/kg, or safinamide 1.0 mg/kg, taken daily. The primary efficacy endpoint was the number of patients with at least 30% improvement in Unified Parkinson's Disease Rating Scale, part III scores.

A total of 172 patients were included in the study. Of 56 patients randomized to each group, 49 completed the placebo arm, 52 the low safinamide dose arm, and 49 the high safinamide dose arm.

"The percentage of responders at study end increased from placebo (12 responders, 21.4%) to the safinamide 0.5-mg/kg group (17 responders, 30.9%) and was highest in the safinamide 1.0 group (21 responders, 37.5%)," Dr. Fariello's group writes.

In a subgroup of 101 stable patients treated with a single dopamine agonist, logistic regression analysis showed that the response was magnified by safinamide.

"These results suggest that doses of safinamide exerting ion channel block and glutamate release inhibition add to its symptomatic effect and warrant exploration of higher doses, they conclude."

Neurology 2004;63:746-648.

Source Date: Sep 03 2004
Source Publication: Reuters / Medscape
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