A randomized clinical trial of lithium in multiple system atrophy

作者：Sacca Francesco^*; Marsili Angela; Quarantelli Mario; Morra Vincenzo Brescia; Brunetti Arturo; Carbone Rosa; Pane Chiara; Puorro Giorgia; Russo Cinzia Valeria; Salvatore Elena; Tucci Tecla; De Michele Giuseppe; Filla Alessandro

来源：Journal of Neurology, 2013, 260(2): 458-461.

DOI：10.1007/s00415-012-6655-7

• Lithium
• Multiple system atrophy
• Clinical trial
• Safety
• Phase II

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 %26lt; 0.01) and a higher number of adverse events (P %26lt; 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.

• 出版日期2013-2