Objective: This study aimed to explore the efficacy of opicapone (OPC) 50 mg versus an extra 100 mg levodopa (L-dopa) dose to treat early wearing-off in Korean patients with Parkinson’s disease (PD).

Background: OPC proved an effective levodopa/dopa decarboxylase inhibitors (DDCi) add-on treatment for end-of-dose motor fluctuations in patients with PD treated and motor fluctuations in two large pivotal clinical trials.

Method: This was a prospective, multicentre, randomised, active-controlled study in which 169 levodopa-treated patients with PD and wearing-off were randomly assigned (1:1) to OPC 50 mg once-daily (n=88) or an additional 100 mg L-dopa dose (n=81). A 1-week screening period was followed by a 4-week maintenance phase. Main endpoint was change from baseline in absolute OFF-time. Secondary endpoints included tolerability, Movement Disorder Society-Unified-PD-Rating-Scale (MDS-UPDRS), 8-item PD Questionnaire (PDQ-8), Clinical Global Impression of Improvement (CGI-I), and Patient Global Impression of Change (PGI-C).

Results: At week 4, mean (standard error [SE]) change from baseline in absolute OFF-time was -62.1 min (9.8) for the OPC 50 mg group and -16.7 min (10.0) for the L-dopa 100 mg group, resulting in a significant difference of -45.4 min (p=0.0015). No significant differences were observed in MDS-UPDRS and PDQ-8 scores between the two groups. The OPC group tended to show greater improvements on CGI-I/PGI-C than the L-dopa group. OPC was well tolerated, but adverse events (AEs) were more frequent in the OPC than the L-dopa group (37.9% vs 18.5%), with dyskinesia (6.9%) being the most common drug-related AE.

Conclusion: OPC can be considered a potential first-line therapy to treat early wearing-off versus the standard L-dopa dose increase approach.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-as-first-line-strategy-for-the-treatment-of-wearing-off-in-korean-patients-with-parkinsons-disease/