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

Background and objective: Pain is a frequent and disabling symptom in Parkinson's disease (PD) patients. Our aim was to analyze the effectiveness of safinamide on pain in PD patients from the SAFINONMOTOR (an open-label study of the effectiveness of SAFInamide on NON-MOTOR symptoms in Parkinson's disease patients) study. Material and Methods: SAFINONMOTOR is a prospective open-label single-arm study conducted in five centers from Spain. In this analysis, a secondary objective of the study, the score in the KPPS (King's Parkinson's Disease Pain Scale) at V1 (baseline) and V4 (6 months +/- 1 month) were compared. Wilcoxon's rank sum test was performed to test the changes from V1 to V4. Results: Forty-four (88%) out of 50 PD patients (age 68.5 +/- 9.12 years; 58% women; 6.4 +/- 5.1 years from diagnosis) completed the study. The KPPS total score was reduced by 43.6% (from 40.04 +/- 36.18 in V1 to 22.60 +/- 21.42 in V4; p < 0.0001). By domains, improvement was observed in musculoskeletal (-35.9%; p = 0.009), fluctuation-related (-51.7%; p = 0.020), nocturnal (-46.1%; p = 0.001), discoloration and/or edema/swelling (-50.4%; p = 0.009) and radicular pain (-40.1%; p = 0.048). A total of 21 adverse events in 11 patients (22%) were reported, five being severe, but not related to safinamide. Conclusion: Safinamide is well tolerated and improves pain in PD patients at 6 months. Future studies are necessary to analyze the possible beneficial effect of safinamide on pain in PD patients.

Automated summary

The SAFINONMOTOR study analyzed the effectiveness of safinamide on pain in Parkinson's disease patients, showing a significant reduction in pain levels within 6 months. Improvement was particularly observed in musculoskeletal, fluctuation-related, nocturnal, discoloration and/or edema/swelling, and radicular pain. Adverse events were reported in 22% of patients, but they were not related to safinamide.