Safinamide belongs to a class of medicines called monoamine oxidase type B inhibitors and is used in conjunction with levodopa to treat off periods.
According to a recent study, treatment with safinamide 50 mg can significantly reduce non-motor symptoms in patients with Parkinson’s disease (PD).
Safinamide is approved as an add-on treatment in Parkinson’s disease for patients taking levodopa and carbidopa to treat off episodes. It belongs to a class of drugs called monoamine oxidase type B inhibitors (MAO-B) and works by increasing the amount of dopamine.
Continued use of levodopa can lead to motor and non-motor fluctuations. This prospective, longitudinal study, conducted in Italy, sought to determine whether safinamide 50 mg could improve non-motor, cognitive, and behavioral symptoms over a 6-month treatment period.
Non-motor symptoms in Parkinson’s, including cognitive impairment, psychiatric symptoms, sleep disorders, autonomic dysfunction, pain and fatigue, are undertreated, the researchers found.
The study was conducted from January 2018 to April 2018 in 20 patients with intermediate-stage Parkinson’s disease. Patients were included if Parkinson’s disease developed after the age of 40, had off-phase motor fluctuations of more than 1.5 hours per day, and had received stable dopaminergic treatment in the past 30 days.
More than half (55%) of the patients were male with a mean age of 63.8 years.
Investigators assessed clinical features using numerous validated PD-specific scales, including the modified Hoehn and Yahr stage and the Unified Parkinson’s Disease Rating Scale Part III, during an on-phase. In addition, the presence of treatment-related motor complications was assessed using UPDRS Part IV.
Non-motor symptoms were assessed using the Non-Motor Symptom Scale (NMSS). Patient-reported quality of life was assessed using the Parkinson’s Disease Questionnaire 39 . The presence and severity of treatment complications were assessed using the Wearing-off Questionnaire 19 and the Abnormal Involuntary Movements Scale.
Neuropsychological and behavioral assessments were performed at baseline and again at 6 months. Global cognitive function was assessed using the Montreal Cognitive Assessment and the PD Cognitive Rating Scale.
Symptoms of depression, anxiety, autonomic dysfunction, sleep disorders, impulsive obsessive-compulsive disorder, pain, apathy, and fatigue were also assessed.
After baseline, all patients started taking safinamide 50 mg daily (patients already taking other MAO-B inhibitors switched). After 6 months of therapy, clinical features were reassessed by the same providers.
Compared to their condition at the start of the study, the researchers noted a significant improvement after 6 months in interest, motivation, apathy, fatigue and urinary tract symptoms, according to the NMSS scale.
Neuropsychiatric assessment showed a significant decrease in fatigue and apathy scores, and motor assessment revealed a significant reduction in total waking time spent in the off phase.
However, there was no change in global cognitive function at 6 months or in pain scores.
The study showed that non-motor and behavioral PD-related symptoms could benefit from even the lowest dose of safinamide, the authors said, possibly due to the drug’s neurotransmitter-receptor-binding profile, but more studies are needed to confirm the effect.
R. De Micco, S. Satolli, M. Siciliano et al. Effects of safinamide on non-motor, cognitive, and behavioral symptoms in patients with fluctuating Parkinson’s disease: a prospective, longitudinal study. Neurol Sci. 2022;43(1):357-364. doi: 10.1007/s10072-021-05324-w