Opicapone OCEAN study in Parkinson's: Design of a randomized double-blind placebo-controlled trial

ABSTRACT

Background and aims: Opicapone (OPC) proved to be effective in the treatment of end-of-dose motor fluctuations in Parkinson's Disease (PD) patients [1,2]. End-of-dose motor fluctuations and associated pain are commonly observed in PD patients on L-dopa/DOPA decarboxylase inhibitors (DDCI). They have a detrimental impact on the quality-of-life [3] and are in part mediated via dopaminergic pathways. [4]. Therefore, an a-priori presumption was made that OPC will overcome end-of-dose fluctuation related pain and consequently improve patients' well-being. Methods: Patients (30 years old) with idiopathic PD, treated with three to eight daily oral doses of L-dopa/DDCI and with 'wearing-off' (end-of-dose deterioration) phenomenology, and experiencing PD associated pain will be randomised (11) to OPC 50mg once-daily or placebo during a 24-week evaluation-period (Figure 1). To detect a minimum clinically relevant magnitude of effect between arms, 70 subjects per group is necessary. Results: The primary endpoint is change from baseline in Domain 3 (fluctuation-related pain) of King's-Parkinson's- Disease-Pain-Scale (KPPS). Secondary endpoints include tolerability, functional motor and non-motor assessments (KPSS, MDS-NMS, PDQ-8, Hauser's home diary), and Global Impression of Change (CGI-C, PGI-C). Study sites are in Germany, Italy, Portugal, Spain and UK. First-patient-in is expected for 2021 and Last-patient-out to late 2022. Timelines might be impacted by COVID-19 pandemic situation. Conclusion: This study will further evaluate the impact of 50mg opicapone once daily as adjunctive therapy to L-dopa/ DDCI on fluctuation-associated pain. (Figure Presented).