Objective: This post-hoc analysis assessed the long-term outcomes of early initiation of opicapone in levodopa-treated patients with early wearing-off in Parkinson’s disease.
Background: The best available data suggest that opicapone use in patients with recent-onset wearing-off yields a higher magnitude of effect than that observed in later stages1. However, the long-term impact of earlier initiation has not been well studied.
Method: Data were pooled from randomized, 3.5-month, double-blind, placebo-controlled trials of opicapone and their 1-year open-label extensions. Analyses included participants initially randomized to placebo or opicapone 50 mg who continued opicapone during the open-label phase and had developed wearing-off within ≤2 years prior to screening. ON/OFF status was assessed using 24-hour patient diaries.
Results: Among 227 participants with recent-onset wearing-off (opicapone=117; placebo=110), opicapone 50 mg significantly reduced OFF-time versus placebo (mean placebo-adjusted reduction: –65.6 min [95% CI: –105.5 to –25.6]; p=0.0014) and increased Good-ON-time (+88.3 min [95% CI: 47.0 to 129.6]; p<0.0001). At the 1-year open-label extension, early starters maintained numerically greater reductions in OFF-time (–30.0 min [95% CI: –74.8 to 14.8]; p=0.20) and increases in Good-ON-time (+38.2 min [95% CI: –6.6 to 82.9]; p=0.09) compared with late opicapone starters (Figure 1, Table 1). Mean levodopa doses remained stable in both groups, and no significant increase in ON-time with troublesome dyskinesia was observed.
Conclusion: Early opicapone in PD patients with early-onset wearing-off provided sustained improvements of ~2.5 hours in OFF-time and Good-ON-time, without increasing dyskinesia or levodopa doses. These results support the use of opicapone in early wearing-off without aggravating the risk of dyskinesia.
Figure 1
Table 1
References: Rocha J-F, Ebersbach G, Lees A, Tolosa E, Ferreira JJ, Poewe W, Rascol O, Stocchi F, Antonini A, Magalhães D, Gama H and Soares-da-Silva P (2021) The Added Benefit of Opicapone When Used Early in Parkinson’s Disease Patients With Levodopa-Induced Motor Fluctuations: A Post-hoc Analysis of BIPARK-I and -II. Front. Neurol. 12:754016. doi: 10.3389/fneur.2021.754016
To cite this abstract in AMA style:
JJ. Ferreira, F. Stocchi, A. Antonini, O. Rascol, G. Ebersbach, J. Kulisevsky, MM. Fonseca, D. Ramos, J-F. Rocha, HC. Brigas, J. Holenz, W. Poewe. Efficacy of Opicapone in Early Motor Fluctuations in Parkinson’s Disease: A Comparison of Early versus Later Initiation [abstract]. Mov Disord. 2026; 41 (suppl 1). https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-early-motor-fluctuations-in-parkinsons-disease-a-comparison-of-early-versus-later-initiation/. Accessed October 1, 2026.« Back to 2026 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/efficacy-of-opicapone-in-early-motor-fluctuations-in-parkinsons-disease-a-comparison-of-early-versus-later-initiation/