Objective: This study aims to evaluate if treatment with opicapone (OPC) 50 mg once-daily can improve motor fluctuation (MF)-related pain in patients with Parkinson’s disease (PD).

Background: OPC has been shown to be generally well tolerated and efficacious in reducing OFF-time in two pivotal trials in patients with PD and end-of-dose MF (BIPARK-I and II). End-of-dose MF and associated pain are commonly reported in patients with PD and have a negative impact on patients’ quality of life.

Method: The OCEAN study is a double-blind, randomised, placebo-controlled trial that aims to recruit ~140 patients (≥30 years old) with idiopathic PD, who were treated with 3−8 daily oral doses of levodopa (L-dopa)/dopa decarboxylase inhibitor (DDCI) and experienced pain associated with end-of-dose MF. Patients will be randomised (1:1) to OPC 50 mg once daily or placebo during a 24-week follow-up period [figure1].

Results: The primary endpoint is change from baseline in domain 3 (fluctuation-related pain) of the King’s-Parkinson’s-Disease-Pain-Scale (KPPS). Secondary endpoints include tolerability, motor and non-motor symptoms (KPSS, Movement Disorder Society-Non-Motor Symptoms, Parkinson’s Disease Questionnaire-8, Hauser’s home diary), and Clinician and Patient Clinical Global Impression of Change. The study received approval in Germany, Italy, Portugal, Spain and the UK. Six sites are actively recruiting and 37 site-initiation-visits have been performed. As of December 2021, 14 patients have been randomised and at least 2 have completed the study.

Conclusion: This study will evaluate the benefit of OPC 50 mg once daily as adjunctive therapy to L-dopa/DDCI on MF-related pain in patients with PD.

Supported by Bial

« Back to 2022 International Congress

MDS Abstracts - https://www.mdsabstracts.org/abstract/ocean-study-in-parkinsons-disease-status-update-of-a-randomised-double-blind-placebo-controlled-trial-of-opicapone/