Nighttime and morning OFF improvements with opicapone in patients with Parkinson's Disease and motor fluctuations: BIPARK-1 and BIPARK-2 pooled subanalyses

Abstract

Background: Opicapone is a once-daily catechol-O-methyltransferase inhibitor for use as an adjunct to levodopa/dopa decarboxylase inhibitor (LD/DDCI) for treating PD patients with motor fluctuations. In 2 double-blind, placebo-controlled, pivotal Phase 3 studies (BIPARK-1 [NCT01568073]; BIPARK-2 [NCT01227655]) opicapone 50 mg significantly reduced OFF time. Nighttime and early morning OFF episodes are significant unmet needs in the treatment of PD. Here, Phase 3 data were pooled to evaluate the effect of opicapone 50 mg on duration of nighttime OFF and time to morning ON in patients with Parkinson's disease (PD) and motor fluctuations.