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

Diego Santos García,Francisco Escamilla Sevilla,Juan Manuel Oropesa-Ruiz,Raúl Rashid Abdul Rahim López,José Guillermo Muñoz Enríquez,Gustavo Fernández Pajarín

doi:10.3390/brainsci12030383

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.

Highlights

Parkinson’s disease (PD), the second most common neurodegenerative disease afterAlzheimer’s disease, is a progressive neurodegenerative disorder causing motor and nonmotor symptoms (NMS) that result in disability, loss of patient autonomy and caregiver burden [1]
The understanding of PD has changed over recent years, with the disease currently considered to be a neurodegenerative disorder involving a diversity of pathways and neurotransmitters that may explain, in part, the wide range of NMS that patients may have such as depression, anxiety, pain, cognitive impairment, apathy, gastrointestinal, urinary or cardiovascular symptoms, fatigue, or sleep problems [2,3]
NMS burden progresses over time in PD [7] and, very importantly, it is strongly correlated to motor complications [8]

Summary

Introduction

Alzheimer’s disease, is a progressive neurodegenerative disorder causing motor and nonmotor symptoms (NMS) that result in disability, loss of patient autonomy and caregiver burden [1]. NMS burden progresses over time in PD [7] and, very importantly, it is strongly correlated to motor complications [8]. In this context, a decrease of daily OFF episodes could help to improve some NMS in PD patients and a drug with an only dopaminergic effect (e.g., COMT inhibitor) could improve NMS [9–11] or hypothetically even the global NMS burden in PD patients [8]

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Conclusion