Session Information
Date: Monday, June 5, 2017
Session Title: Epidemiology
Session Time: 1:45pm-3:15pm
Location: Exhibit Hall C
Objective: Here we present the design of a Drug Utilization Study of safinamide in the first post-commercialization phase and report results of the study feasibility conducted in Europe.
Background: Levodopa is the most effective therapy in Parkinson’s disease (PD), but its use is limited by the development of motor complications over time. Safinamide is a new pharmacotherapy, which combines inhibition of both MAO-B and sodium channels, leading to both dopaminergic and non-dopaminergic activities. It is indicated as add-on therapy for treatment of idiopathic PD, in mid-to late-stage fluctuating patients receiving a stable dose of levodopa, either alone or in combination with other PD medications.
Methods: SYNAPSES study is an ongoing, observational, European, multicentre, retrospective-prospective cohort study. Primary objective is to describe the occurrence of adverse events in patients treated with safinamide in real-life conditions. Secondary objectives include the description of patients’ characteristics treated with safinamide according to clinical practice and safinamide treatment patterns in real-life. A special focus will be laid on patients’ population aged > 75 years and with relevant concomitant conditions.
The study will observe 1600 patients in 140 centers across 7 European countries during 1 year after the initiation of safinamide treatment.
The study feasibility was conducted by a phone structured interview.
Statistics are provided as the median calculated across sites or overall proportion.
Results: Among 135 interviewed European sites, a total of 47427 idiopathic PD patients in fluctuating mid-to-late-stage received a stable dose of levodopa in 2015 and the median (25-75th percentiles) patients/site was 250 (150-400).
Out of the total, 24429 (52%) patients also received MAOB-inhibitors, 1389 (3%) had concomitant hepatic impairment and 784 (2%) had ophthalmological history.
The median (25-75th percentile) portion of patients >75-year-old was 35% across sites (20%-50%; N=17026).
The total number of patients suffering from psychiatric conditions was 1765 (3.7%).
The first patient was enrolled in August 2016.
Conclusions:
The structured survey showed that the study is feasible in European sites. The SYNAPSES study will extend the knowledge about safinamide safety profile and treatment patterns.
To cite this abstract in AMA style:
G. Camattari, G. Abbruzzese, W. Jost, J. Kulisevsky, V. Tubazio, L. Simoni, The SYNAPSES investigators. The SYNAPSES study (StudY to observe SafiNAmide in clinical Practice during the firSt post-commErcialization phaSe): methodology and results from the European feasibility survey [abstract]. Mov Disord. 2017; 32 (suppl 2). https://www.mdsabstracts.org/abstract/the-synapses-study-study-to-observe-safinamide-in-clinical-practice-during-the-first-post-commercialization-phase-methodology-and-results-from-the-european-feasibility-survey/. Accessed May 17, 2025.« Back to 2017 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/the-synapses-study-study-to-observe-safinamide-in-clinical-practice-during-the-first-post-commercialization-phase-methodology-and-results-from-the-european-feasibility-survey/