Objective: This study aims to evaluate the effect of once-daily opicapone (OPC) 50 mg versus an additional dose of levodopa (L-dopa)/dopa decarboxylase inhibitor (DDCi) to optimise the L-dopa/DDCi regimen as first-line approach to treat wearing-off in Parkinson’s disease (PD) patients.

Background: Long-term treatment with L-dopa in PD patients is often associated with the development of wearing-off symptoms. The catechol-O-methyltransferase inhibitor OPC proved to be effective in reducing wearing-off symptoms in two pivotal Phase III trials (BIPARK-I and -II).

Method: ADOPTION is a randomised, open-label, exploratory clinical trial that will include patients aged ≥30 years with idiopathic PD, who received 3−4 daily oral L-dopa doses (up to 600 mg) and developed signs of wearing-off (<2 years). Patients will be randomised to OPC 50 mg once daily or to an additional dose of 100 mg/25 mg L-dopa/DDCI during a 4-week open-label follow-up period [figure1]. Approximately 100 patients from 25 sites in 5 different countries are planned to be recruited.

Results: The primary endpoint is change from baseline in OFF-time measured by motor fluctuation diaries. Secondary endpoints include tolerability, motor and non-motor assessments (Movement Disorder Society (MDS)-Unified Parkinson’s Disease Rating Scale, MDS-Non-Motor Symptoms, Parkinson’s Disease Questionnaire-8), and Clinician and Patient Global Impression of Change. The study has already been initiated in two countries.

Conclusion: This study will evaluate the potential of adjunctive OPC versus an additional dose of L-dopa/DDCi as first-line approach to treat wearing-off in patients with PD.

Supported by Bial

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MDS Abstracts - https://www.mdsabstracts.org/abstract/adoption-study-status-update-of-a-randomised-open-label-exploratory-trial-of-opicapone-in-parkinsons-disease/