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 baseline OFF-time 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 baseline OFF-time in efficacy outcomes (i.e., change from baseline in OFF-/ON-time). Linear regression was applied and the slope was statistically tested for deviation from zero.
Results: 1027 patients were randomized to BIPARK-I and II; 522 patients took a dose of study medication; Full Analysis Set comprised 517 [PLC (n=255); OPC-50mg (n=262)]. As expected, both treatments arms presented the same increased dependent tendency for OFF-/ON-time at endpoint, i.e., the longer OFF-time at baseline the greater magnitude of response at endpoint (ending in a linear regression slope statistically significant). When OFF-time at endpoint was ‘normalized’ as % of change in relation to baseline, the linear regression slope was found non-significant for both treatment arms, though the increased dependent tendency was still found.
Conclusion: Baseline OFF-time appears to impact the magnitude of both OFF- and ON-time responses 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:
A. Santos, J. Ferreira, A. Lees, H. Reichmann, W. Poewe, F. Ikedo, D. Magalhães, J. Rocha, P. Soares-da-Silva. Influence of baseline OFF-time 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-baseline-off-time-in-the-efficacy-response-of-parkinsons-disease-patients-with-motor-fluctuations-post-hoc-analysis-from-combined-bipark-i-and-ii/. Accessed May 18, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/influence-of-baseline-off-time-in-the-efficacy-response-of-parkinsons-disease-patients-with-motor-fluctuations-post-hoc-analysis-from-combined-bipark-i-and-ii/