Category: Parkinson’s Disease: Clinical Trials
Objective: To evaluate the effects of opicapone (OPC) treatment on sleep disorders in patients with Parkinson’s disease (PD) and ‘wearing-off’.
Background: OPC proved to be effective in the treatment of end-of-dose motor fluctuations in PD patients [1,2]. Non-motor symptoms have a substantial impact on health-related quality of life and are reported in about 90% of idiopathic patients with PD [3]. End-of-dose motor fluctuations and associated sleep disorders are commonly observed in patients with PD who receive treatment with L-dopa/DOPA decarboxylase inhibitors (DDCI).
Method: Approximately 30 patients (aged ≥30 years) with idiopathic PD, treated with 3−8 daily oral doses of L-dopa/DDCI, with ‘wearing-off’ and sleep disorders will receive OPC 50 mg once-daily during a 6-week evaluation period. L-dopa/DDCI daily dose, but not number of intakes, may be adjusted according to the patient’s response in the first 2 weeks, and is kept unchanged afterwards (Figure 1). As a pilot study, no formal sample size calculation was performed.
Results: The primary endpoint is change from baseline in total score of Parkinson’s Disease Sleep Scale-2 (PDSS-2). Secondary endpoints include tolerability, functional motor and non-motor assessments (MDS- Non-Motor Symptoms Scale [NMS], Parkinson’s Disease Questionnaire-8 [PDQ-8], Fatigue Scale [PFS-16], ON/OFF home diary), and global impression of change scales (Clinical Global Impression of Change [CGI-C], Patient Global Impression of Change [PGI-C]). Study sites are in Germany and Portugal. First-patient-in is expected for 2021 and last-patient-out for late 2021. Timelines might be impacted by the COVID-19 pandemic situation.
Conclusion: This study will evaluate the impact of OPC 50 mg once-daily as adjunctive therapy to L-dopa/DDCI on PD-associated sleep disorders.
References: 1. Ferreira et al., Lancet Neurol. 2016;15(2):154-165 2. Lees et al., JAMA Neurol. 2017;74(2):197-206 3. Gökçal et al., Noro Psikiyatr Ars. 2017;54(2):143-148
To cite this abstract in AMA style:
R. Costa, C. Trenkwalder, J. Ferreira, D. Magalhães, J. Rocha, P. Soares-da-Silva. The OASIS (OpicApone in Sleep dISorder) study in Parkinson’s disease: design and rationale of an open-label, single-arm, pilot trial [abstract]. Mov Disord. 2021; 36 (suppl 1). https://www.mdsabstracts.org/abstract/the-oasis-opicapone-in-sleep-disorder-study-in-parkinsons-disease-design-and-rationale-of-an-open-label-single-arm-pilot-trial/. Accessed June 15, 2025.« Back to MDS Virtual Congress 2021
MDS Abstracts - https://www.mdsabstracts.org/abstract/the-oasis-opicapone-in-sleep-disorder-study-in-parkinsons-disease-design-and-rationale-of-an-open-label-single-arm-pilot-trial/