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 opicapone’s (OPC) efficacy in levodopa-treated Parkinson’s Disease (PD) patients with or without concurrent pramipexole use (CPU).
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. Studies had similar designs (primary efficacy endpoint: change from baseline in patient diaries-based absolute OFF-time) and eligibility criteria [1],[2]. This exploratory post-hoc analysis was performed to evaluate OPC-50mg and PLC efficacies in levodopa-treated PD patients with or without baseline CPU (the most commonly used dopamine agonist).
Results: In total, 535 patients were randomized; Full Analysis Set comprised 517 [PLC (n=255); OPC-50mg (n=262)]. About 37% of patients in each arm were using pramipexole at baseline. Mean placebo-adjusted OFF-time reductions were -89.0min (p=0.0001) and -39.8min (p=0.0165) for OPC-50mg patients with and without CPU. There was ~45% more OFF-time reduction in PLC patients without CPU than in those with, but ~20% less OFF-time reduction in OPC-50mg patients without CPU than in those with. A higher-than-PLC proportion of OPC-50mg-receiving patients with CPU achieved OFF- (72.9% vs. 40.4%; p<0.0001) and ON-time (68.8% vs. 42.6%; p=0.0003) responders’ endpoint. Consistently, a higher-than-PLC proportion of OPC-50mg-receiving patients without CPU achieved OFF- (64.5% vs. 54.0%; p=0.0551) and ON-time (60.2% vs. 47.2%; p=0.0169) responders’ endpoint.
Conclusion: Opicapone was effective regardless of concurrent pramipexole use.
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. Lees, J. Ferreira, O. Rascol, W. Poewe, F. Stocchi, A. Santos, D. Magalhães, J. Rocha, P. Soares-da-Silva. Efficacy of opicapone in Parkinson’s disease patients according to baseline pramipexole use: a post-hoc analysis from combined BIPARK-I and II. [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-parkinsons-disease-patients-according-to-baseline-pramipexole-use-a-post-hoc-analysis-from-combined-bipark-i-and-ii/. Accessed May 24, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-parkinsons-disease-patients-according-to-baseline-pramipexole-use-a-post-hoc-analysis-from-combined-bipark-i-and-ii/