Objective: To objectively evaluate the effects of Safinamide in patients with Parkinson’s (PD) by using the Parkinson’s KinetiGraphTM (PKG), a newly developed tool for graphically depiction of movement disorders.

Background: Since May 2015, Safinamide has been approved as add-on therapy to a stable dose of levodopa alone or in combination with other PD therapies for mid-to late-stage fluctuating patients. Safinamide is supposed to extend the On-state in PD patients and might also reduce PD-associated dyskinesia. In order to measure these effects the pivot trials applied the commonly used subjective patient diaries. An objective analysis of the Safinamide effects as measured by the PKG tool concerning dyskinesia, bradykinesia and affected fluctuations may add valid information about real life treatment impacts.

Methods: We examined 5 patients (mean age 64.8 ± 10.16, mean Hoehn & Yahr stadium 2.9 ± 0.55, mean L-dopa-dose 915 ± 171mg) suffering from PD since 11.2 ± 2.59 years before and at least after an 8 week period of Safinamide 100mg intake per day. All patients complained about intraday fluctuations and dyskinesia. Developed by Global Kinetic Corporation and worn at the wrist of the more affected side, the PKG allows for objective recording of PD movement patterns and is able to give representative bradykinesia (BKS) and dyskinesia (DKS) scores as well as a specific fluctuation-dyskinesia-score (FDS) over a 6-day-recording-period.

Results: The mean BK-value (standard value 18.6) was 18.26 ± 7.42 before and 20.76 ± 6.73 after a several-week-intake of Safinamide. The mean pre-DK-value (standard value 4.3) was 13.94 ± 19.47, the mean post-DK-value 10.3 ± 7.86. The mean slightly FDS (standard range 7.8-12.8) increased from 14.66 ± 6.42 to 15.02 ± 5.68. A global subjective improvement in real life was reported by 3 patients, 2 did not notice any relevant changes in clinical presentation. The PKG showed a decrease of the FDS in 2 of the 3 subjectively improved patients as the main objective correlate with subjective impressions.

Conclusions: The most distinct change after Safinamide intake was a decrease in the mean dyskinesia score (- 3.64). However, when looking at single patients the subjective impression of Safinamide effects was more strongly correlated with the change in the mean fluctuation score. In 1 patient no correlation between subjective impression and objective analysis was found.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effects-of-safinamide-in-patients-with-parkinsons-disease-measured-by-parkinsons-kinetigraphtm/