Effects of safinamide on pain in Parkinson's disease with motor fluctuations: an exploratory study.

Pain is a common and disabling non-motor symptom (NMS) of Parkinson's disease (PD), which occurs through the course of the disease, often unrecognized and undertreated. For this study, we evaluated the efficacy and safety of safinamide to reduce pain in PD patients with motor fluctuations. A total of 13 PD patients with pain receiving safinamide (Xadago®, 100 mg/daily) were prospectively evaluated for 12 weeks. The primary outcome measures were changes in the total score of the King's Pain Scale for Parkinson's Disease (KPPS), Brief Pain Inventory (BPI) Intensity and Interference, and the Numeric Rating Scale (NRS). Secondary outcomes were the proportion of pain responders, changes in the Clinical Global Impression of Change (CGI), the Parkinson's disease Quality of Life 39 (PDQ39), the Unified Parkinson's Disease Rating Scale parts III and IV (UPDRS III and IV), and laser-evoked potentials (LEPs). LEPs were used to assess potential changes in the central processing of nociceptive inputs. The safety profile was evaluated based on the occurrence of treatment-emergent side effects and the dropout rate. After 12 weeks of add-on safinamide therapy, a significant improvement was noted in the primary (KPPS, BPI Intensity and interference, and NRS) and the secondary outcomes (UPDRS III, IV, CGI, and PDQ39). No significant changes in LEP complexes were observed. All patients completed the study and no treatment-emergent side effects were reported. Our preliminary findings suggest that safinamide 100 mg/day may be effective for the management of pain in PD patients with motor fluctuations and is safe. Further randomized controlled trials are needed to confirm its efficacy.