Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To evaluate the efficacy of opicapone (OPC) in levodopa-treated Parkinson’s Disease (PD) ‘non-responders’ patients who switched from placebo (PLC) or entacapone (ENT) to OPC in BIPARK-I open-label part.
Background: OPC, a once-daily COMT inhibitor, proved effective in the treatment of motor fluctuations in PD patients in two large, pivotal, multinational trials (BIPARK-I and II) [1],[2].
Method: After completing BIPARK-I double-blind part, PLC- and ENT-patients switched to a 1-year open-label extension under OPC-treatment. This post-hoc analysis investigated the change from open-label baseline in absolute OFF-time in ‘non-responders’ PLC and ENT ‘switchers’. Non-responders, as assessed by Patient Global Impression of Change (PGI-C), were any subjects who had no improvement by double-blind endpoint. A linear mixed-effect model repeated measurement (MMRM) with region as factor and baseline as covariate was applied.
Results: In total, 199 patients switched from PLC (n=99) or ENT (n=100) to 1-year OPC open-label extension. From these, ~45% were PGI-C ‘non-responders’ for both groups. After 1-year treatment with OPC, for PLC-patients defined as ‘non-responders’ at double-blind endpoint, switching to OPC resulted in a statistical significant additional reduction of OFF-time (-83.8 min, p= 0.0003). Likewise, switching ENT ‘non-responders’ to open-label OPC resulted in a statistical significant additional reduction of OFF-time (-45.3 min, p= 0.0399). ‘Non-responders’ patients (~23%) originally allocated to OPC-50mg in the double-blind phase also showed greater response but not statistically significant.
Conclusion: Switching entacapone ‘non-responders’ to open-label opicapone resulted in a statistical significant reduction of OFF-time.
References: [1] Ferreira et al., Lancet Neurology 2016; 15(2):154-165. [2] Lees et al., JAMA Neurol. 2017; 74(2):197-206.
To cite this abstract in AMA style:
J. Ferreira, A. Lees, W. Poewe, O. Rascol, A. Santos, D. Magalhães, J. Rocha, P. Soares-da-Silva. Switching entacapone ‘non-responders’ to open-label opicapone: change in absolute OFF-time following the 1-year extension BIPARK-I study [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/switching-entacapone-non-responders-to-open-label-opicapone-change-in-absolute-off-time-following-the-1-year-extension-bipark-i-study/. Accessed May 15, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/switching-entacapone-non-responders-to-open-label-opicapone-change-in-absolute-off-time-following-the-1-year-extension-bipark-i-study/