Open Access Study protocol

Protocol for a double-blind randomised placebo-controlled trial of lithium carbonate in patients with amyotrophic Lateral Sclerosis (LiCALS) [Eudract number: 2008-006891-31]

Ammar Al-Chalabi1*, Pamela J Shaw2, Carolyn A Young3, Karen E Morrison4, Caroline Murphy5, Marie Thornhill1, Joanna Kelly5, I Nicholas Steen6, P Nigel Leigh17 and on behalf of UKMND-LiCALS

Author Affiliations

1 MRC Centre for Neurodegeneration Research, King's College London, Department of Clinical Neuroscience, London SE5 8AF, UK

2 Academic Neurology Unit, Sheffield Institute for Translational Neuroscience (SITraN), University of Sheffield, 385A Glossop Road, Sheffield S10 2HQ, UK

3 Walton Centre for Neurology & Neurosurgery, Lower Lane, Liverpool L9 7LJ, UK

4 College of Medical and Dental Sciences, University of Birmingham, Birmingham, B15 2TT, UK

5 Mental Health and Neuroscience Clinical Trials Unit, King's College London, Institute of Psychiatry, London SE5 8AF, UK

6 Institute of Health and Society, University of Newcastle upon Tyne, 21 Claremont Place, Newcastle upon Tyne, NE2 4AA, UK

7 Brighton and Sussex Medical School, Trafford Centre for Biomedical Research, University of Sussex, Falmer, East Sussex BN1 9RY, UK

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BMC Neurology 2011, 11:111  doi:10.1186/1471-2377-11-111

Published: 21 September 2011

Additional files

Additional file 1:

Appendix for Protocol for a double-blind randomised placebo-controlled trial of Lithium Carbonate in patients with Amyotrophic Lateral Sclerosis (LiCALS) [EudraCT number: 2008-006891-31]. More detail on methods for compliance and withdrawal rules, data monitoring, quality control and quality assurance, access to source data, pharmacovigilance, ethics and regulatory issues, finance, insurance, and the publication policy.

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