Long‐term efficacy and safety of safinamide as add‐on therapy in early Parkinson's disease. Issue 2 (12th September 2012)

• Record Type: Journal Article
• Authors: Schapira, A. H. V.; Stocchi, F.; Borgohain, R.; Onofrj, M.; Bhatt, M.; Lorenzana, P.; Lucini, V.; Giuliani, R.; Anand, R.
• Is Part Of: European journal of neurology. Volume 20:Issue 2(2013:Feb.)
• Page Start: 271
• Page End: 280
• Publication Date: 2012-09-12
• Subjects: Neurology -- Periodicals; Nervous system -- Diseases -- Periodicals; 616.8
• DOI: 10.1111/j.1468-1331.2012.03840.x
• Languages: English
• ISSNs: 1351-5101

Abstract

<abstract abstract-type="main" id="ene3840-abs-0001"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="ene3840-sec-0001" sec-type="section"> <title>Background and purpose</title> <p>Safinamide is an α‐aminoamide with both dopaminergic and non‐dopaminergic mechanisms of action in Phase III clinical development as a once‐daily add‐on to dopamine agonist (DA) therapy for early Parkinson's disease (PD).</p> </sec> <sec id="ene3840-sec-0002" sec-type="section"> <title>Methods</title> <p>Study 017 was a 12‐month, randomized, double‐blind, placebo‐controlled pre‐planned extension study to the previously reported Study 015. Patients received safinamide 100 or 200 mg/day or placebo added to a single DA in early PD. The primary efficacy endpoint was the time from baseline (Study 015 randomization) to 'intervention', defined as increase in DA dose; addition of another DA, levodopa or other PD treatment; or discontinuation due to lack of efficacy. Safinamide groups were pooled for the primary efficacy endpoint analysis; <italic>post hoc</italic> analyses were performed on each separate dose group.</p> </sec> <sec id="ene3840-sec-0003" sec-type="section"> <title>Results</title> <p>Of the 269 patients randomized in Study 015, 227 (84%) enrolled in Study 017 and 187/227 (82%) patients completed the extension study. Median time to intervention was 559 and 466 days in the pooled safinamide and placebo groups, respectively (log‐rank test; <italic>P </italic>= 0.3342). In <italic>post hoc</italic> analyses, patients receiving safinamide 100 mg/day experienced a significantly lower rate of intervention compared with placebo (25% vs. 51%, respectively) and a delay in median time to intervention of 9 days (<italic>P </italic><<italic> </italic>0.05; 240‐ to 540‐day analysis).</p> </sec> <sec id="ene3840-sec-0004" sec-type="section"> <title>Conclusions</title> <p>The pooled data from the safinamide groups failed to reach statistical significance for the primary endpoint of median time from baseline to additional drug intervention. <italic>Post hoc</italic> analyses indicate that safinamide 100 mg/day may be effective as add‐on treatment to DA in PD.</p> </sec> </abstract>