Safinamide as Add-On Therapy to Levodopa in Mid- to Late-Stage Parkinson's Disease Fluctuating Patients: Post hoc Analyses of Studies 016 and SETTLE.

Daily ON time with no/non-troublesome dyskinesia and daily OFF time For the primary efficacy variable in both studies, mean changes from baseline (in daily ON time with no or non-troublesome dyskinesia) were significantly greater than the changes observed with placebo, therefore a highly significant difference with placebo was also obtained when pooling the two studies: 1.42 h (95% CI: 1.21, 1.64, p < 0.0001) versus 0.58 h (95% CI: 0.37, 0.80) observed with placebo, mean difference between safinamide and placebo 0.84 h; see Table 1 .

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Stratifications according to the administration of other baseline medications (in addition to a stable dose of levodopa) were not bound to provide a clear trend, since concomitant multiple adjunctive treatments at baseline were admitted in addition to levodopa; in fact, only few patients (10%) in the pooled studies ITT population had no additional baseline treatments, i.e., were receiving levodopa as their sole dopaminergic treatment on entering the studies; the majority of patients (90%) had indeed one or more concomitant baseline treatments, and thus patient subgroups by single adjunctive treatment partlyoverlapped.

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