Objective: To evaluate the impact on non-motor symptoms in levodopa-treated Parkinson’s disease (PD) patients who switched from placebo (PLC) or entacapone (ENT) to opicapone (OPC) in the BIPARK-I open-label (OL) part.

Background: OPC, a novel once-daily COMT inhibitor, has shown to be effective in the treatment of motor fluctuations in PD patients in two large, pivotal, multinational trials (BIPARK-I and II) [1,2].

Methods: After completing the BIPARK-I double-blind (DB) part, PLC- and ENT-patients switched to a 1-year OL extension, in which all subjects received OPC. This post-hoc analysis investigated the impact on Non-Motor Symptoms Scale (NMSS) score in PLC and ENT ‘switchers’ using a linear mixed-effect model repeated measurement (MMRM) with region as factor and OL baseline as covariate.

Results: A total of 199 patients switched from PLC (n=99) or ENT (n=100) to 1-year OPC open-label treatment. By the end of the DB period, the post-baseline NMSS total scores decreased in all treatment groups, indicating less disability in non-motor domains. The LS mean changes from DB baseline were -5.7, -4.7 and -2.0 for PLC, ENT and OPC-50mg, respectively. By the end of the 1-year OL OPC extension, the post-baseline NMSS total scores further decreased. The LS mean changes [95%CI] from OL baseline were -3.8 [-7.5, -0.2], -0.2 [-3.8, 3.4] and -0.4 [-4.0, 3.3] for PLC, ENT and OPC-50mg, respectively. There was no worsening of NMSS for ENT switched-subjects and the -3.8 change from OL baseline was found to be statistically significant for the PLC switched-subjects (p=0.0409).

Conclusions: As measured by the NMSS, there appeared to be no worsening of non-motor symptoms for subjects switching from DB treatment with ENT. PLC switched-subjects from DB to OL opicapone presented significantly less disability.

References: 1. Ferreira JJ, Lees A, Rocha JF, Poewe W, Rascol O, Soares-da-Silva P, et al. Opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial. Lancet Neurol 2016;15:154-165. 2. Lees AJ, Ferreira J, Rascol O, Poewe W, Rocha JF, McCrory M, et al. Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial. JAMA Neurol 2017;74:197-206.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/switching-from-double-blind-entacapone-or-placebo-to-open-label-opicapone-nmss-results-of-the-1-year-extension-bipark-i-study/