Purpose: To evaluate the efficacy and safety of opicapone in older participants (≥65 years).
Rationale: Opicapone is an oral once-daily catechol-O-methyltransferase (COMT) inhibitor approved as an adjunctive treatment to levodopa/carbidopa in patients with Parkinson’s disease (PD) experiencing “OFF”-episodes. This post hoc analysis utilized pooled data from two pivotal phase 3 studies, BIPARK-1 (NCT01568073) and BIPARK-2 (NCT01227655).
Conceptual/theoretical framework: Opicapone has sufficient clinical data to specifically indicate no required dose adjustment in older patients (≥65 years). These data can therefore be used to describe treatment effects of opicapone in an older study population.
Methods: In BIPARK-1 and BIPARK-2, participants received 14/15 weeks of double-blind treatment with opicapone 50 mg (OPC-50) or placebo (PBO). The pooled study data were analyzed by treatment in older participants and the pooled full analysis set (FAS [included for context]). Least-squares mean changes from baseline to week 14/15 in absolute “OFF”-time and absolute “ON”-time without troublesome dyskinesia were analyzed using a mixed model for repeated measures. Treatment-emergent adverse events (TEAEs) were analyzed descriptively.
Results: The pooled FAS included 517 participants, 251 (48.5%) of whom were ≥65 years old. Significant reductions in “OFF”-time (hours) with OPC-50 versus PBO were similar between older participants (OPC-50, -2.29 [P