Category: Parkinson’s Disease: Clinical Trials
Objective: The OASIS exploratory trial aimed to evaluate the effects of opicapone (OPC) on sleep disorders in Parkinson’s disease (PD) patients with motor fluctuations (MF) and associated sleep disorders treated with levodopa.
Background: MF and associated sleep disorders are common in patients with PD receiving levodopa/dopa decarboxylase inhibitors, negatively affecting their quality of life. The catechol-O-methyl transferase inhibitor opicapone (OPC) proved to be effective in reducing end-of-dose MF in patients with PD.
Method: In the exploratory, open-label, single-arm pilot OASIS trial, all patients (N=16) received OPC 50 mg once-daily as add-on to levodopa/dopa decarboxylase therapy for 6 weeks. Primary endpoint was change from baseline in PD Sleep Scale-2 (PDSS-2). Secondary endpoints included tolerability, functional motor and non-motor assessments (Movement Disorder Society [MDS]-Unified Parkinson’s Disease Rating Scale [UPDRS], MDS-Non-motor Scale [NMS], 8-item PD Questionnaire [PDQ-8], 16-item PD Fatigue Scale [PFS-16], ON/OFF home diary), and Clinical and Patient Global Impression of Change (CGI-C; PGI-C).
Results: At week 6, there was a significant reduction of -7.9 points (95%CI -13.6,-2.2; p=0.0099) in total PDSS-2 score. Significant reductions were also observed in PFS-16 (-9.6 [95%CI -17.5,-1.7; p=0.0211]), MDS-NMS total score (-28.9 [95%CI -44.7,-13.2; p=0.0052]), MDS-UPDRS-III and IV (-6.3 [95%CI -11.6,-0.9; p=0.0253] and -1.2 [95%CI -2.0,-0.4; p=0.0044], respectively) and PDQ-8 (-14.2 [95%CI -23.3,-5.0; p=0.0051]). Absolute OFF-time was reduced (-142.1 mins), while ON-time without dyskinesia was increased (+127.1 mins). Most patients (93.3%) and most clinicians (80.0%) reported an improvement as evaluated by the PGI-C and CGI-C, respectively. OPC was found to be well tolerated.
Conclusion: Adding OPC 50 mg to levodopa therapy improved sleep disturbances and other non-motor symptoms, supporting OPC’s potential to treat MF in patients with PD-related sleep disorders.
To cite this abstract in AMA style:
J. Ferreira, M. Gago, R. Costa, M. Fonesca, J. Almeida, J. Rocha, J. Holenz, C. Trenkwalder. Opicapone Effect on Sleep Disorders in Fluctuating Parkinson’s Disease Patients: Findings from the OASIS Trial [abstract]. Mov Disord. 2024; 39 (suppl 1). https://www.mdsabstracts.org/abstract/opicapone-effect-on-sleep-disorders-in-fluctuating-parkinsons-disease-patients-findings-from-the-oasis-trial/. Accessed June 15, 2025.« Back to 2024 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-effect-on-sleep-disorders-in-fluctuating-parkinsons-disease-patients-findings-from-the-oasis-trial/