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 impact of disease severity on the efficacy of opicapone (OPC) in levodopa-treated Parkinson’s disease (PD) patients with motor fluctuations.
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: Patient-level data from matching treatment arms in BIPARK-I and II were combined in placebo (PLC) and OPC-50mg groups. The studies had similar designs (primary efficacy endpoint: change from baseline in patient diaries-based absolute OFF-time) and eligibility criteria [1],[2]. An exploratory post-hoc analysis was performed to evaluate the influence of disease severity (assessed by modified Hoehn and Yahr, H&Y <2.5 vs >=2.5) on efficacy outcomes (i.e., change from baseline in OFF-/ON-time). Applied linear regression’s slope was statistically tested for deviation from zero and linearity.
Results: In total, 1027 patients were randomized to BIPARK-I and II and 522 patients took a dose of study medication; Full Analysis Set comprised 517 [PLC (n=255); OPC-50mg (n=262)]. Two PLC patients with H&Y=4 were excluded from disease severity analysis as there were no OPC-50mg matched-patients. For OPC-50mg, OFF-/ON-time magnitude of responses was not influenced (non-significant linear regression). For PLC, the higher H&Y staging at baseline the greater magnitude of OFF-/ON-time response at endpoint (ending in a linear regression slope statistically significant).
Conclusion: Disease severity impacted OFF-/ON-time magnitude of responses for PLC but not OPC-50mg patients in a clinical study setting.
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:
H. Gama, A. Lees, J. Ferreira, O. Rascol, A. Antonini, A. Santos, D. Magalhães, J. Rocha, P. Soares-da-Silva. Influence of disease severity in the efficacy response of Parkinson’s disease patients with motor fluctuations: post-hoc analysis from combined BIPARK-I and II [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/influence-of-disease-severity-in-the-efficacy-response-of-parkinsons-disease-patients-with-motor-fluctuations-post-hoc-analysis-from-combined-bipark-i-and-ii/. Accessed July 6, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/influence-of-disease-severity-in-the-efficacy-response-of-parkinsons-disease-patients-with-motor-fluctuations-post-hoc-analysis-from-combined-bipark-i-and-ii/