Long-term Follow-up of Opicapone Use as Add-on to Levodopa in Parkinson’s Patients Without Motor Fluctuations: Findings from the EPSILON Study
Joaquim Ferreira1, Olivier Rascol2, Fabrizio Stocchi3, Angelo Antonini4, Paloma Lapuente5, Guillermo Castilla-Fernández5, Helena Brigas5, Ghazal Banisadr6, José-Francisco Rocha5, Joerg Holenz5, Werner Poewe7
1IMM Instituto de Medicina Molecular João Lobo Antunes, Faculdade de Medicina, Universidade de Lisboa; CNS-Campus Neurológico, 2Clinical Investigation Centre CIC1436 Departments of Neurosciences and Clinical Pharmacology, Centre of Excellence for Neurodegeneration COEN NeuroToul, and NS-Park/FCRIN network; University of Toulouse 3, University Hospital of Toulouse, INSERM, 3University San Raffaele Roma and Institute for Research and Medical Care IRCCS, 4Parkinson and Movement Disorders Unit, Centre for Rare Neurological Diseases (ERN-RND), Department of Neuroscience, University of Padova, 5BIAL – Portela & Ca S.A., 6Amneal Pharmaceuticals, 7Department of Neurology, Medical University of Innsbruck
Objective:
To assess the long-term effect of opicapone (OPC) in enhancing the clinical benefit of oral Levodopa therapy in Parkinson’s Disease (PD) patients without motor complications.
Background:
Opicapone is routinely used to optimize levodopa in PD patients with motor complications. The EPSILON study investigated Opicapone’s clinical efficacy in PD patients without motor complications.
Design/Methods:
This was a randomized, double-blind (DB), placebo-controlled (PLC) study followed by a 1-year open-label (OL) extension. Levodopa-treated PD patients without motor complications were randomized to 24 weeks of DB treatment with adjunct opicapone 50mg or matching placebo. Patients who completed this phase entered a 1-year OL extension where all patients received opicapone 50mg. The primary endpoint was the mean change from DB baseline to week 24 in MDS-UPDRS-III. The mean change from OL baseline to week 52 in MDS-UPDRS-IV was the key endpoint for the OL extension.
Results:
At week 24, OPC significantly improved MDS UPDRS-Part III score compared to PLC (mean difference [Standard deviation (SD)] of -2.2(0.9)). Patients who remained on opicapone (OPC-OPC, n=121) had sustained motor improvement of -0.6(8.79) over the 1-year OL period, with negligible daily levodopa adjustments. Patients switching from placebo to opicapone (PLC-OPC, n=129), showed a mean -2.1(7.9) improvement, consistent with the treatment effects of OPC in the DB period. The PLC-OPC group had a slightly lower magnitude of effect over time compared to the OPC-OPC group, with a least squared mean treatment difference of 1.3 (95% CI: -3.3, 0.7; p=0.196) at the end of OL period. Fewer OPC-OPC patients reported motor complications (MDS-UPDRS Part IV total score ≥1) compared to the PLC-OPC group (11.6% vs. 16.3%, p=ns), with a mean score of 0.3 for both groups.
Conclusions:
This data supports persistent beneficial motor effects over 12 months without increasing dyskinesia risk following the addition of opicapone to levodopa in PD subjects without motor fluctuations.
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