Session Information
Date: Saturday, October 6, 2018
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:45pm-3:15pm
Location: Hall 3FG
Objective: To evaluate the impact on UPDRS-II and III 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 both UPDRS-II and III scores in the 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 extension. By the end of the DB period, the post-baseline UPDRS-II and III total scores decreased in all treatment groups, indicating less disability in both non-motor and motor domains, respectively. The LS mean changes of UPDRS-II from DB baseline were -2.4, -3.1 and -3.0 for PLC, ENT and OPC-50mg, respectively. By the end of the 1-year OL OPC extension, the post-baseline UPDRS-II total scores further decreased for PLC (-2.5) and ENT (-0.9) switched-subjects. Therefore, there was no worsening of UPDRS-II for ENT switched-subjects and the -2.5 change from OL baseline was found to be statistically significant for the PLC switched-subjects (p<.0001). The LS mean changes of UPDRS-III from DB baseline were -3.7, -4.4 and -4.5 for PLC, ENT and OPC-50mg, respectively. By the end of the 1-year OL OPC extension, the post-baseline UPDRS-III total scores further decreased for PLC (-3.9) and ENT (-2.3) switched-subjects. Both the PLC (-3.9) and ENT (-2.3) changes from OL baseline were found to be statistically significant (p<.0001 and p=0.0016, respectively).
Conclusions: There was no worsening in UPDRS non-motor and motor domains for both ENT and PLC switched-subjects to 1-year open-label OPC. Switching from double-blind PLC to open-label OPC presented significantly less disability in both UPDRS non-motor and motor domains. Switching from double-blind ENT to open-label OPC presented significantly less disability in the UPDRS motor domain.
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.
To cite this abstract in AMA style:
R. Ehret, J. Ferreira, F. Stocchi, F. Ikedo, E. Arbe, J-F. Rocha, P. Soares-da-Silva. Switching from double-blind entacapone or placebo to open-label opicapone: UPDRS-II and III results of the 1-year extension BIPARK-I study [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/switching-from-double-blind-entacapone-or-placebo-to-open-label-opicapone-updrs-ii-and-iii-results-of-the-1-year-extension-bipark-i-study/. Accessed June 15, 2025.« Back to 2018 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/switching-from-double-blind-entacapone-or-placebo-to-open-label-opicapone-updrs-ii-and-iii-results-of-the-1-year-extension-bipark-i-study/