Safinamide improves non-motor symptoms in PD

An open-label study confirmed previously observed beneficial effects of safinamide on non-motor symptoms of Parkinson’s disease (PD). Safinamide was well tolerated and improved both non-motor symptom burden and quality of life (QoL) in PD patients after 6 months.

Safinamide is a new monoamine oxidase (MAO) B inhibitor which also exerts a non-dopaminergic effect. The SAFINONMOTOR trial is a prospective, open-label, single-arm study to assess the effectiveness of safinamide on non-motor symptoms in PD patients [1]. The study's primary endpoint is change from baseline (V1) after 6 months (V4) in the Non-Motor Symptoms Scale (NMSS) total score. A total of 50 PD patients were included. Median age was 68.5; 58% were women; they had been diagnosed a mean of 6.4 years before. A total of 44 (88%) completed the follow-up observational period of 6 months.

The NMSS total score was reduced by 38.5% (P<0.0001) after 6 months: at baseline, it was 97.5; after 1 month, 65.9; after 3 months, 59.4; and after 6 months, 59.9. Improvement was observed in the following domains: sleep/fatigue (-35.8%; P=0.002), mood/apathy (-57.9%; P<0.0001), attention/memory (-23.9%; P=0.026), gastrointestinal symptoms (-33%; P=0.010), urinary symptoms (-28.3%; P=0.003), and pain/miscellaneous (-43%; P<0.0001). QoL, as measured by the 39-item Parkinson's Disease Questionnaire summary index (PDQ-39SI) improved by 29.4%: from 30.1 at baseline to 21.2 at 6 months (P<0.0001).

Eleven patients (22%) reported a total of 21 adverse events (AEs). Five AEs were severe, but none were deemed treatment related. The most frequent were dyskinesias and nausea (6%).

1. Santos Garcia D, et al. Safinamide Improves Non-Motor Symptoms Burden in Parkinson´s Disease: An Open-label Prospective Study. OPR-108, EAN 2021 Virtual Congress, 19–22 June.

 

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Posted on 18 August 202117 May 2024