Category: Parkinson’s Disease: Clinical Trials
Objective: The aim of this study was to analyze the effectiveness of opicapone on global non-motor symptoms (NMS) burden in Parkinson´s disease (PD).
Background: Some studies observed a benefit of PD patients after treatment with opicapone in some NMS.
Method: 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 (V0M) to the end of the observational period (6 months ± 1 month) (V6M) 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. P values were computed using the Wilcoxon signed-rank test.
Results: 33 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) (Table 1). 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 in V0M to 52.1 ± 34.76 in V6M; 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) (Table 2). 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 in V0M to 21.75 ± 14.9 in V6M; 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) (Table 3). Dyskinesias and nausea were the most frequent (6.1%).
Conclusion: Opicapone is well tolerated and improves global NMS burden and QoL in PD patients at 6 months.
To cite this abstract in AMA style:
D. Santos García, G. Fernández Pajarín, J. Oropesa Ruíz, F. Escamilla Sevilla, R. Rahim Lopez, G. Muñoz Enríquez. Opicapone Improves Global Non-Motor Symptoms Burden in Parkinson´s Disease: An Open-label Prospective Study [abstract]. Mov Disord. 2022; 37 (suppl 2). https://www.mdsabstracts.org/abstract/opicapone-improves-global-non-motor-symptoms-burden-in-parkinsons-disease-an-open-label-prospective-study/. Accessed November 21, 2024.« Back to 2022 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/opicapone-improves-global-non-motor-symptoms-burden-in-parkinsons-disease-an-open-label-prospective-study/