Objective: This study aims to evaluate the effects of opicapone (OPC) 50 mg treatment on sleep disorders in patients with Parkinson’s disease (PD) and ‘wearing-off’.

Background: Non-motor symptoms have a substantial impact on health-related quality of life and are reported in ~90% of patients with idiopathic PD. End-of-dose motor fluctuations (MF) and associated sleep disorders are commonly observed in PD patients receiving levodopa (L-dopa)/dopa decarboxylase inhibitors (DDCi). OPC is a once daily catechol-O-methyltransferase inhibitor that proved effective in reducing end-of-dose MF in patients with PD in two large multinational trials (BIPARK-I and -II).

Method: OASIS is an open-label, exploratory trial aiming to recruit ~30 patients (aged ≥30 years) with idiopathic PD, treated with 3−8 daily doses of L-dopa/DDCi, with ‘wearing-off’ and sleep disorders. Patients will receive OPC 50 mg once daily during a 6-week evaluation period [figure1].

Results: The primary endpoint is change from baseline in total score of Parkinson’s Disease Sleep Scale-2. Secondary endpoints include tolerability, motor and non-motor assessments (Movement Disorder Society-Non-Motor Symptoms Scale, Parkinson’s Disease Questionnaire-8, Parkinson’s Fatigue Scale, ON/OFF home diary), and Clinician and Patient Global Impression of Change. The study has been approved in Germany and Portugal. As of December 2021, 4 patients have been randomised.

Conclusion: This exploratory study will provide preliminary data on the potential benefit of OPC 50 mg once daily as adjunctive therapy to L-dopa/DDCI on PD-associated sleep disorders.

Supported by Bial

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MDS Abstracts - https://www.mdsabstracts.org/abstract/open-label-single-arm-exploratory-trial-of-opicapone-status-update-of-the-oasis-opicapone-in-sleep-disorder-study/