Published in:
01-02-2013 | Original Communication
A randomized clinical trial of lithium in multiple system atrophy
Authors:
Francesco Saccà, Angela Marsili, Mario Quarantelli, Vincenzo Brescia Morra, Arturo Brunetti, Rosa Carbone, Chiara Pane, Giorgia Puorro, Cinzia Valeria Russo, Elena Salvatore, Tecla Tucci, Giuseppe De Michele, Alessandro Filla
Published in:
Journal of Neurology
|
Issue 2/2013
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Abstract
The aim of our study was to test the safety and tolerability of lithium in multiple system atrophy (MSA). The study was randomized, placebo-controlled, and double-blind. The primary endpoint of the study was safety and tolerability. An interim analysis, performed 1 year after the first patient was randomized, showed a higher proportion of trial abandon (P < 0.01) and a higher number of adverse events (P < 0.02) in the lithium group. The trial was stopped by the Data Monitoring Committee. Overall, lithium was not well tolerated, and we do not encourage future studies with lithium in MSA patients.