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.

疼痛是帕金森病 (PD) 的一种常见且致残的非运动症状 (NMS)，它在整个疾病过程中发生，通常未被识别和治疗不足。在本研究中，我们评估了 safinamide 减轻有运动波动的 PD 患者疼痛的有效性和安全性。对总共 13 名接受 safinamide（Xadago®，100 mg/天）的疼痛 PD 患者进行了 12 周的前瞻性评估。主要结局指标是帕金森病国王疼痛量表 (KPPS)、简要疼痛量表 (BPI) 强度和干扰以及数字评定量表 (NRS) 总分的变化。次要结果是疼痛反应者的比例、临床总体变化印象 (CGI) 的变化、帕金森病生活质量 39 (PDQ39)、统一帕金森病评定量表第三部分和第四部分（UPDRS III 和 IV）以及激光诱发电位 (LEP)。LEP 用于评估伤害性输入的中央处理的潜在变化。根据治疗中出现的副作用和退出率来评估安全性。在附加 safinamide 治疗 12 周后，主要结果（KPPS、BPI 强度和干扰以及 NRS）和次要结果（UPDRS III、IV、CGI 和 PDQ39）显着改善。没有观察到 LEP 复合物的显着变化。所有患者都完成了研究，没有报告治疗出现的副作用。我们的初步研究结果表明，safinamide 100 mg/day 可能对治疗伴有运动波动的 PD 患者的疼痛有效并且是安全的。