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.
A randomized clinical trial of lithium in multiple system atrophy / Sacca', Francesco; Marsili, A; Quarantelli, M; BRESCIA MORRA, Vincenzo; Brunetti, Arturo; Carbone, R; Pane, Chiara; Puorro, G; Russo, CINZIA VALERIA; Salvatore, Elena; Tucci, T; DE MICHELE, Giuseppe; Filla, Alessandro. - In: JOURNAL OF NEUROLOGY. - ISSN 0340-5354. - 260:(2013), pp. 458-561. [10.1007/s00415-012-6655-7]
A randomized clinical trial of lithium in multiple system atrophy.
SACCA', FRANCESCO;BRESCIA MORRA, VINCENZO;BRUNETTI, ARTURO;PANE, CHIARA;RUSSO, CINZIA VALERIA;SALVATORE, ELENA;DE MICHELE, GIUSEPPE;FILLA, ALESSANDRO
2013
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.| File | Dimensione | Formato | |
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