Objective: To evaluate opicapone’s effect on sleep disturbances, motor and non-motor symptoms and quality of life in Parkinson’s disease (PD) patients with and without probable rapid eye movement sleep (REM) behavior disorder (RBD).

Background: RBD is prevalent in PD, worsening sleep quality and disease burden. 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 PD patients with motor fluctuations and sleep disturbances. Assessments included PD Sleep Scale-2 (PDSS-2), Movement Disorder Society-sponsored Non-Motor Symptoms rating scale (MDS-NMS), OFF/ON-time, Patient and Clinician Global Impressions of Change, Parkinson’s Fatigue Scale-16 (PFS-16), Parkinson’s Disease Questionnaire-8 (PDQ-8), and presence of early morning dystonia. This post-hoc analysis of OASIS compared results in PD patients with and without probable RBD as determined by their medical history.

Results: Of the 16 patients included, 8 (50%) had probable RBD. After 6 weeks of opicapone treatment, similar improvements in mean±standard error PDSS-2 total scores were reported in patients with RBD (-8.4±5.1) and without RBD (-7.5±2.6) [Figure 1a], including in the score of disturbed sleep domain [Figure 1b]. Functional impact analyses showed similar reductions in OFF-time (-124.3±52.8 min for patients with RBD; -160±67.5 min for those without RBD) and increases in ON-time without dyskinesia (+131.4±67.4 min vs. +122.9±56.2 min) [Figure 1c]. Similar improvements in MDS-UPDRS Parts III and IV, PFS-16, and PDQ-8 scores were reported. Improvements in MDS-NMS scores were numerically lower in patients with RBD (-20.0±14.6) than in those without RBD (-36.8±4.9). Most patients (86%) and clinicians (71.4%) reported improvements for PD patients with RBD [Table 1]. Opicapone was well tolerated in both groups.

Conclusion: Adding opicapone 50 mg to levodopa in patients with PD, motor fluctuations and sleep disturbances improved sleep complaints to a similar extent in those with and without probable RBD, although the analysis is limited by low patient numbers.

Figure 1

Table 1

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MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-in-parkinsons-patients-with-probable-rem-sleep-behavior-disorder-insights-from-the-oasis-trial/