Safinamide Improves Non-Motor Symptoms Burden in Parkinson’s Disease: An Open-Label Prospective Study

Abstract

Some studies observed a benefit of Parkinson´s disease (PD) patients after treatment with safinamide in some non-motor symptoms (NMSs). The aim of this study was to analyze the effectiveness of safinamide on NMS burden in PD. SAFINONMOTOR (an open-label study of the effectiveness of safinamide on non-motor symptoms in Parkinson´s disease patients) is a prospective open-label single-arm study conducted in five centers from Spain. The primary efficacy outcome was the change from baseline (V1) to the end of the observational period (6 months) (V4) in the non-motor symptoms scale (NMSS) total score. Between May/2019 and February/2020 50 patients were included (age 68.5 ± 9.12 years; 58% females; 6.4 ± 5.1 years from diagnosis). At 6 months, 44 patients completed the follow-up (88%). The NMSS total score was reduced by 38.5% (from 97.5 ± 43.7 in V1 to 59.9 ± 35.5 in V4; p <0.0001). By domains, improvement was observed in 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). Quality of life (QoL) also improved with a 29.4% reduction in the PDQ-39SI (from 30.1 ± 17.6 in V1 to 21.2 ± 13.5 in V4; p < 0.0001). A total of 21 adverse events in 16 patients (32%) were reported, 5 of which were severe (not related to safinamide). Dyskinesias and nausea were the most frequent (6%). Safinamide is well tolerated and improves NMS burden and QoL in PD patients with severe or very severe NMS burden at 6 months.

Predictors of Global Non-Motor Symptoms Burden Progression in Parkinson’s Disease. Results from the COPPADIS Cohort at 2-Year Follow-Up

“…The risk is higher when the score is lower, signifying that even in early PD patients it is necessary to be alert when the patient has a low global NMS burden because it is liable to increase. Again, it is logical to consider and on the contrary, a greater improvement in NMS after an intervention has been observed in patients with a greater NMS burden [ 50 ], so changes are related to the score at baseline.…”

Pain Improvement in Parkinson’s Disease Patients Treated with Safinamide: Results from the SAFINONMOTOR Study

“…Patients with PD according to the United Kingdom Parkinson’s Disease Society Brain Bank criteria [ 20 ] without dementia [ 21 ] who were considered for treating with safinamide by the neurologist having a NMSS total score ≥ 40 were included. SAFINONMOTOR methods are available in: (accessed on 13 August 2021) [ 12 ].…”

“…Moreover, other scales were administered by protocol in different visits of the study. The methodology of the SAFINONMOTOR study can be consulted in (accessed on 13 August 2021) [ 12 ]. Importantly, the analysis about the change in pain (KPPS total score) from V1 to V4 was a specific proposed secondary objective in the protocol of the SAFINONMOTOR study.…”

“…In previous trials, safinamide improved both motor scores and duration of “on time”, and was also well-tolerated and safe [ 9 , 10 ]. Furthermore, data from some studies suggest a possible benefit of PD patients after treatment with safinamide in global NMS burden [ 11 , 12 ] and in some NMS in particular such as sleep, mood or urinary symptoms [ 13 , 14 , 15 ]. With regard to pain, very recently Geroin et al [ 16 ] observed, after 3 months of add-on safinamide therapy, a significant improvement in the primary outcomes (KPPS (KPPS King’s Parkinson’s Disease Pain Scale), BPI (Brief Pain Inventory) Intensity and Interference and NRS (Numeric Rating Scale)) in 13 PD patients with pain.…”

“…We observed very recently an improvement in the global NMS burden in 50 PD patients from the SAFINONMOTOR study [ 12 ]. In this analysis, a secondary objective of the SAFINONMOTOR study, we evaluated in detail the change in pain throughout the 6-month follow-up in PD patients treated with safinamide.…”