Objective: To evaluate the real-world effectiveness of safinamide on non-motor symptoms, sleep disturbances, and mood in patients with Parkinson’s disease receiving safinamide as the first add-on therapy to levodopa.
Background: Safinamide is a selective MAO-B inhibitor with both dopaminergic and non-dopaminergic mechanisms that may positively influence non-motor symptoms in Parkinson’s disease (PD). Although its motor benefits are well established, evidence regarding its impact on non-motor symptoms in real-world clinical practice remains limited.
Method: This prospective, observational, multicenter study included patients aged ≥18 years with Parkinson’s disease who initiated safinamide as the first add-on to levodopa therapy. Clinical and functional assessments were performed at baseline, 3 months, and 6 months using validated scales, including SCOPA (total and subscales), Epworth Sleepiness Scale (ESS), Parkinson’s Disease Sleep Scale (PDSS), Beck Depression Inventory (BDI), and Clinical Global Impression (CGI). Longitudinal analyses were restricted to patients with complete data across all visits.
Results: Among the 35 patients included at baseline, 16 completed the 6-month follow-up, with no significant changes in levodopa dosage during follow-up. Total SCOPA scores differed significantly over time (p=0.022), showing a clinically relevant reduction between 3 and 6 months. Daytime sleepiness assessed by ESS also showed significant overall differences (p=0.019), with a significant improvement between months 3 and 6 (adjusted p=0.010). Depressive symptoms, measured by BDI, improved significantly between 3 and 6 months (adjusted p=0.001). PDSS scores showed a trend toward improvement without reaching statistical significance. Most patients were rated as clinically improved according to CGI-I.
Conclusion: Safinamide was associated with progressive improvement in non-motor symptom burden, particularly daytime sleepiness and depressive symptoms, supporting benefits beyond motor control in real-world practice settings.
To cite this abstract in AMA style:
F J. Salazar Hernández, M. Cerdán Sánchez, B. Palazón Cabanes, A E. Báidez Guerrero, M. Ruiz Perelló, B. Gómez Gozálvez, D. López Segura, A. Sancho Pedros, M. Lorente Hernández. Safindream Safinamide as First Add On to Levodopa Improves Nonmotor Symptoms in Parkinson disease A Prospective Real World Study [abstract]. Mov Disord. 2026; 41 (suppl 1). https://www.mdsabstracts.org/abstract/safindream-safinamide-as-first-add-on-to-levodopa-improves-nonmotor-symptoms-in-parkinson-disease-a-prospective-real-world-study/. Accessed October 1, 2026.« Back to 2026 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/safindream-safinamide-as-first-add-on-to-levodopa-improves-nonmotor-symptoms-in-parkinson-disease-a-prospective-real-world-study/