Eur J Neurol. 2012 Sep 12. doi: 10.1111/j.1468-1331.2012.03840.x. [Epub ahead of print]
Schapira AH, Stocchi F, Borgohain R, Onofrj M, Bhatt M, Lorenzana P, Lucini V, Giuliani R, Anand R.
Source
Department of Clinical Neurosciences, University College London, Institute of Neurology, London, UK.
Abstract
BACKGROUND AND PURPOSE:
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).
METHODS:
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; post-hoc analyses were performed on each separate
dose group.
RESULTS:
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; P = 0.3342). In post-hoc analyses, patients receiving
safinamide 100 mg/day experienced a significantly lower rate of
intervention compared with placebo (25% vs. 51%, respectively) and
delay in median time to intervention of 9 days (P < 0.05; 240- to
540-day analysis).
CONCLUSIONS:
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. Post-hoc analyses indicate that safinamide 100 mg/day may
be effective as add-on treatment to DA in PD.
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