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.
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Acknowledgments
The study was supported by Associazione Italiana per la lotta alle Sindromi Atassiche (AISA) sez. Campania. We are grateful to Dr. Ettore Brunello Florio from the Farmacia Florio Dr. Ettore SNC pharmacy for the knowledge, assistance, and expertise in the pharmaceutical preparation of lithium and placebo. We thank the patients and their families for their willingness to take part to this research project.
Conflicts of interest
The authors report no competing interests.
Ethical standard
All human studies must state that they have been approved by the appropriate ethics committee and have therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki.
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Saccà, F., Marsili, A., Quarantelli, M. et al. A randomized clinical trial of lithium in multiple system atrophy. J Neurol 260, 458–461 (2013). https://doi.org/10.1007/s00415-012-6655-7
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DOI: https://doi.org/10.1007/s00415-012-6655-7