Opicapone Improves Global Non-Motor Symptoms Burden in Parkinson's Disease: An Open-Label Prospective Study

Abstract

Patients with Parkinson’s disease (PD) can improve some non-motor symptoms (NMS) after starting treatment with opicapone. The aim of this study was to analyze the effectiveness of opicapone on global NMS burden in PD. OPEN-PD (Opicapone Effectiveness on Non-motor symptoms in Parkinson’s Disease) is a prospective open-label single-arm study conducted in 5 centers from Spain. The primary efficacy outcome was the change from baseline (V0) to the end of the observational period (6 months ± 30 days) (V2) in the Non-Motor Symptoms Scale (NMSS) total score. Different scales were used for analyzing the change in motor, NMS, quality of life (QoL), and disability. Thirty-three patients were included between JUL/2019 and JUN/2021 (age 63.3 ± 7.91; 60.6% males; 7.48 ± 4.22 years from symptoms onset). At 6 months, 30 patients completed the follow-up (90.9%). The NMSS total score was reduced by 27.3% (from 71.67 ± 37.12 at V0 to 52.1 ± 34.76 at V2; Cohen’s effect size = −0.97; p = 0.002). By domains, improvement was observed in sleep/fatigue (−40.1%; p < 0.0001), mood/apathy (−46.6%; p = 0.001), gastrointestinal symptoms (−20.7%; p = 0.029), and miscellaneous (−44.94%; p = 0.021). QoL also improved with a 18.4% reduction in the 39-item Parkinson’s Disease Quality of Life Questionnaire Summary Index (from 26.67 ± 17.61 at V0 to 21.75 ± 14.9 at V2; p = 0.001). A total of 13 adverse events in 11 patients (33.3%) were reported, 1 of which was severe (not related to opicapone). Dyskinesias and nausea were the most frequent (6.1%). Opicapone is well tolerated and improves global NMS burden and QoL in PD patients at 6 months.

Keywords: Parkinson’s disease; effectiveness; non-motor symptoms; open-label study; opicapone.

Figure 1

(A). NMSS total score at V0 (baseline), V1 (2 months ± 15 days), and V2 (6 months ± 30 days). V2 vs. V0, p = 0.002; V1 vs. V0, p = 0.001; and V2 vs. V1, p = 0.202. (B). PDQ-39SI at V0, V1, and V2. V2 vs. V0, p = 0.001; V1 vs. V0, p = 0.008; and V2 vs. V1, p = 0.496. Data are presented as box plots, with the box representing the median and the two middle quartiles (25–75%). p values were computed using the Wilcoxon signed-rank test. Mild outliers (O) are data points that are more extreme than Q1—1.5. NMS, non-motor symptoms; PDQ-39SI, 39-item Parkinson’s Disease Questionnaire Summary Index.

Figure 2

(A). Mean score on each domain of the NMSS scale at V0 (baseline), V1 (2 months ± 15 days), and V2 (6 months ± 30 days). The difference between V2 and V0 was significant for NMSS-2 (Sleep/fatigue) (p < 0.0001), NMSS-3 (Mood/apathy) (p < 0.001), NMSS-6 (Gastrointestinal symptoms) (p = 0.029), and NMSS-9 (Miscellaneous) (p = 0.021). (B). Mean score on each domain of the PDQ-39SI at V0, V1, and V2. The difference between V2 and V0 was significant for PDQ-39SI-3 (Emotional well-being) (p = 0.004), PDQ-39SI-4 (Stigmatization) (p = 0.009), and PDQ-39SI-8 (Pain and discomfort) (p = 0.023). p values were computed using the Wilcoxon signed-rank test.

Figure 3

NMS burden with regard to the NMSS total score (0–20, slight burden; 21–40, moderate burden; 41–70, severe burden; 71–360 very severe burden) at V0, (baseline), V1 (2 months ± 14 days), and V2 (6 months ± 30 days). V2 vs. V0, p = 0.001; V1 vs. V0, p = 0.001; V2 vs. V1, p = 0.366.