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. 2022 Nov;129(11):1331-1338.
doi: 10.1007/s00702-022-02538-w. Epub 2022 Sep 7.

Non-motor symptoms burden in motor-fluctuating patients with Parkinson's disease may be alleviated by safinamide: the VALE-SAFI study

Claudia De Masi #  1 , Claudio Liguori #  2   3   4 , Matteo Spanetta  5 , Mariana Fernandes  5 , Rocco Cerroni  1 , Elena Garasto  1 , Mariangela Pierantozzi  1   5   6 , Nicola Biagio Mercuri  1   5   7 , Alessandro Stefani  1   5   6
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Non-motor symptoms burden in motor-fluctuating patients with Parkinson's disease may be alleviated by safinamide: the VALE-SAFI study

Claudia De Masi et al. J Neural Transm (Vienna). 2022 Nov.

Abstract

Parkinson's disease (PD) is characterized by motor symptoms often experienced in concomitance with non-motor symptoms (NMS), such as depression, apathy, pain, sleep disorders, and urinary dysfunction. The present study aimed to explore the effect of safinamide treatment on NMS and quality of life in motor-fluctuating PD patients. VALE-SAFI is an observational single-centre study performed in fluctuating PD patients starting safinamide treatment and followed for 6 months. The effects of safinamide on NMS, sleep, fatigue, depression and pain were assessed through validated sales. Changes in the scales from baseline to the 6-month follow-up visit were analysed. 60 PD patients (66.67% males) were enrolled at baseline, and 45 patients completed the 6-month follow-up. PD patients improved motor symptoms at follow-up, with the significant reduction of motor fluctuations. The global score of the NMS Scale significantly decreased between baseline and the follow-up. Regarding pain domains, patients reported a significant improvement in discolouration and oedema/swelling. Further, a significant improvement was observed from baseline to follow-up in sleep quality measured through the Pittsburgh Sleep Quality Index, while no changes were documented in daytime sleepiness. No differences were found in depression and fatigue between baseline and follow-up. Finally, the patient's perception of the impact of PD on functioning and well-being decreased from baseline to follow-up. The present findings confirmed the beneficial effect of safinamide on both motor and non-motor symptoms, also improving the quality of life of PD patients. Furthermore, these data support the positive effects of safinamide on pain and mood, as well as on sleep quality and continuity.

Keywords: Daytime sleepiness; Movement disorder; Pain; Quality of life; Sleep.

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Conflict of interest statement

This study was supported by an unrestricted grant from Zambon to A.S. No other financial disclosures or conflict of interests related to this study are present.

Figures

Fig. 1
Fig. 1
Flow chart of the study and patients’ baseline demographic and clinical characteristics
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