Overnight Switch From Rasagiline To Safinamide

Summary

Rasagiline label report the indication to wait at least 14 days between discontinuation of rasagiline and initiation of another MAO inhibitor. This results in a major inconvenience for Parkinsonian patients (PD) due to their clinical worsening. Safinamide is a reversible MAO-B inhibitor, characterized by a good safety profile. In clinical practice safinamide is often introduced instead of rasagiline following an overnight switch. The aim of this study is to explore the safety and tolerability of the immediate switch from rasagiline (irreversible MAO-B inhibitor) to safinamide, with the expectation that there will be no adverse events or increased risk of hypertensive crisis for patients with PD or signs of serotonin syndrome

Timeline

Start

2018-05-01

Primary completion

2019-03-31

Completion

2019-05-31

Publications

• Background Muller T, Hoffmann JA, Dimpfel W, Oehlwein C. Switch from selegiline to rasagiline is beneficial in patients with Parkinson's disease. J Neural Transm (Vienna). 2013 May;120(5):761-5. doi: 10.1007/s00702-012-0927-3. Epub 2012 Nov 30.
• Background Stocchi F, Borgohain R, Onofrj M, Schapira AH, Bhatt M, Lucini V, Giuliani R, Anand R; Study 015 Investigators. A randomized, double-blind, placebo-controlled trial of safinamide as add-on therapy in early Parkinson's disease patients. Mov Disord. 2012 Jan;27(1):106-12. doi: 10.1002/mds.23954. Epub 2011 Sep 12.
• Background Marquet A, Kupas K, Johne A, Astruc B, Patat A, Krosser S, Kovar A. The effect of safinamide, a novel drug for Parkinson's disease, on pressor response to oral tyramine: a randomized, double-blind, clinical trial. Clin Pharmacol Ther. 2012 Oct;92(4):450-7. doi: 10.1038/clpt.2012.128. Epub 2012 Sep 5.

Drugs

Indications