EAN 2021 | SAFINONMOTOR: safinamide for Parkinson’s disease non-motor symptoms

SAFINONMOTOR is a descriptive, observational, longitudinal, prospective open-label study conducted in Spain. In five centers from Spain, Galicia in the northwest of Spain, in which the change in the global non-motor symptoms total burden in 50 PD patients after six months with safinamide was analyzed. So we used a non-motor symptoms scale, and importantly all patients presented at baseline as a severe or very non-motor symptoms burden. Moreover, other scales were used for assessing the change in specific non-motor symptoms, quality of life and disability.

The study included a baseline visit and follow-up visits at one month with 50 milligrams per day, and at three and six months with 100 milligrams per day of safinamide. And the primary endpoint was the change in the non-motor symptoms scale total score from the baseline visit to the last follow-up visit at six months. In general, safinamide was well tolerated. And 44 patients, this is near to 90% of the patients, were receiving safinamide at six months. A total of 21 adverse events were reported. Five of them were severe, but no one related to safinamide.

About 80% of the patients reduced their non-motor symptoms scale total score, and the mean score was reduced in near to 40%, from 97 points at baseline to 60 points at six months. And by domains, the improvement was observed most significantly in sleep/fatigue, depression/anxiety, urinary symptoms and miscellaneous, including pain. Moreover, an improvement in quality of life was observed with a reduction of near 30% in the PDQ-39 summary index, being most significantly in mobility or autonomy for activities of daily living, emotional well-being, pain and discomfort.

Importantly, we didn’t observe changes between the dose of safinamide at one month with 50 milligrams per day and at three and six months with 100 milligrams per day. So the interpretation is actually a improvement early with only 50 milligrams per day, and the fact that this improvement is present after six months with 100 milligrams per day. With regards studied, and to this aspect it’s not clear the actual mechanism, what mechanism could be involved. A dopaminergic mechanism for example, modulating of the glutamate.

So in summary, despite of limitation from this study, for example not having a placebo arm, we think that the results are of great interest. And we can try, we can think about safinamide as a good option for PD patients with significant non-motor symptoms in clinical practice.