Objective: To evaluate opicapone’s effect on sleep disturbances, motor/non-motor symptoms and quality of life in Parkinson’s disease (PD) patients with and without probable Rapid eye movement sleep behavior disorder (RBD), as determined by their medical history.

Background: RBD is prevalent in PD. Opicapone improved sleep disturbances in fluctuating PD patients with PD-related sleep disturbances in the exploratory Phase IV OpicApone in Sleep dISorder (OASIS) trial.

Method: The 6-week, single-arm OASIS trial evaluated opicapone 50 mg in levodopa-treated fluctuating PD patients with sleep disturbances. Assessments included PD Sleep Scale-2 (PDSS-2), Movement Disorder Society-sponsored Non-Motor Symptoms rating scale (MDS-NMS), Patient and Clinician Global Impressions of Change, Parkinson’s Fatigue Scale-16 (PFS-16), Parkinson’s Disease Questionnaire-8 (PDQ-8).

Results: Of the 16 patients included, 8 (50%) had probable RBD. After 6 weeks with opicapone, similar reductions in PDSS-2 total scores were reported in patients with (-8.4 ± 5.1) and without RBD (-7.5 ± 2.7). Improvements were mostly seen in the disturbed sleep domain, with >35% improvement in items assessing poor sleep quality in the previous week, sleep latency, sleep fragmentation, and non-restorative sleep in both groups. No early-morning dystonia was reported in patients with probable RBD. Similar improvements in OFF-time/ON-time without dyskinesia, MDS-UPDRS Parts III and IV, PFS-16, and PDQ-8 scores were observed. Opicapone was well-tolerated in both groups.

Conclusion: Adding opicapone to levodopa in patients with PD, wearing-off and sleep disturbances improved sleep complaints similarly in patients with and without probable RBD, although the analysis is limited by the small sample size.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-for-management-of-sleep-disturbances-in-parkinsons-disease-post-hoc-analysis-of-the-oasis-trial-in-patients-with-and-without-probable-rbd/