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Journal of Neurology

, Volume 260, Issue 2, pp 458–461 | Cite as

A randomized clinical trial of lithium in multiple system atrophy

  • Francesco SaccàEmail author
  • 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
Original Communication

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.

Keywords

Lithium Multiple system atrophy Clinical trial Safety Phase II 

Notes

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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Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Francesco Saccà
    • 1
    Email author
  • Angela Marsili
    • 1
  • Mario Quarantelli
    • 2
  • Vincenzo Brescia Morra
    • 1
  • Arturo Brunetti
    • 2
  • Rosa Carbone
    • 1
  • Chiara Pane
    • 1
  • Giorgia Puorro
    • 1
  • Cinzia Valeria Russo
    • 1
  • Elena Salvatore
    • 1
  • Tecla Tucci
    • 1
  • Giuseppe De Michele
    • 1
  • Alessandro Filla
    • 1
  1. 1.Department of Neurological SciencesUniversity Federico IINaplesItaly
  2. 2.Biostructure and Bioimaging InstituteNational Research CouncilNaplesItaly

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