Objective: To evaluate the efficacy and safety of Opicapone drug in patients with Parkinson’s disease (PD) using an updated systematic review and meta-analysis, including newly published randomized controlled trials (RCTs).

Background: Opicapone is a drug that is given once daily and performs as a Catechol-O-Methyltransferase (COMT) inhibitor, it extends Levodopa’s effects and reduces OFF time. It enhances both motor symptom control and treatment as an add-on therapy. An updated analysis of available RCTs is necessary to further shed light on its role in clinical practice, as the continuous development in PD treatment.

Method: This study was conducted following the PRISMA guidelines. We searched on PubMed, Embase, and Cochrane Library from inception until February 2025. The Selection criteria included RCTs evaluating Opicapone in PD patients. Outcomes were OFF time change, ON time without dyskinesia, UPDRS-III scores, PDQ-39, NMSS, and safety. Risk of bias was assessed using ROB2 tool. Heterogeneity was conducted using I², and a fixed-effects model was performed due to low heterogeneity.

Results: Five RCTs with 1337 patients were eligible. Opicapone significantly reduced OFF time (-48.21 min [95% CI: -65.11, -31.30], P < 0.0001, I² = 0%)[Figure1] and increased ON time without troublesome dyskinesia (+35.26 min [95% CI: 16.31, 54.21], P = 0.0003)[Figure2]. Absolute ON time was significantly increased (+48.31 min [95% CI: 30.55, 66.07], P < 0.00001). However, no significant improvement was shown in UPDRS-III scale (MD: -0.59 [95% CI: -1.89, 0.71], P = 0.37). Relative risk of dyskinesia was increased (OR: 3.67, P < 0.0001), but ON time with troublesome dyskinesia was not significantly affected (MD: 6.14 min [95% CI: -0.64, 12.93], P = 0.08). No significant changes were detected in PDQ-39 and NMSS scores.[Figure2]

Conclusion: This study states Opicapone’s efficacy in reducing OFF episodes and increasing ON time without worsening dyskinesia. No significant improvement found in UPDRS-III scores. Its tolerability remains acceptable, but further research is required to optimize its role in PD treatment.

[Figure1]

[Figure2]

[Figure3]

References: [1] J. J. Ferreira et al., “Opicapone as adjunct to levodopa in treated Parkinson’s disease without motor complications: A randomized clinical trial,” Eur J Neurol, vol. 32, no. 1, p. e16420, Jan. 2025, doi: 10.1111/ENE.16420.
[2] J. Y. Lee et al., “Opicapone to Treat Early Wearing-off in Parkinson’s Disease Patients: The Korean ADOPTION Trial,” Mov Disord Clin Pract, vol. 11, no. 6, pp. 655–665, Jun. 2024, doi: 10.1002/MDC3.14030.
[3] A. Takeda et al., “Randomized, Controlled Study of Opicapone in Japanese Parkinson’s Patients with Motor Fluctuations,” Mov Disord, vol. 36, no. 2, pp. 415–423, Feb. 2021, doi: 10.1002/MDS.28322.
[4] J. J. Ferreira, A. Lees, J. F. Rocha, W. Poewe, O. Rascol, and P. Soares-da-Silva, “Opicapone as an adjunct to levodopa in patients with Parkinson’s disease and end-of-dose motor fluctuations: a randomised, double-blind, controlled trial,” Lancet Neurol, vol. 15, no. 2, pp. 154–165, Feb. 2016, doi: 10.1016/S1474-4422(15)00336-1.
[5] A. J. Lees et al., “Opicapone as Adjunct to Levodopa Therapy in Patients With Parkinson Disease and Motor Fluctuations: A Randomized Clinical Trial,” JAMA Neurol, vol. 74, no. 2, pp. 197–206, Feb. 2017, doi: 10.1001/JAMANEUROL.2016.4703.

« Back to 2025 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/comparative-efficacy-and-safety-of-opicapone-in-parkinsons-disease-an-updated-systematic-review-and-meta-analysis/