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.
2013
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]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11588/516873
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