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Proof of concept studies for tissue-protective agents in multiple sclerosis

Mehta, L. R. and Schwid, S. R. and Arnold, D. L. and Cutter, G. R. and Aradhye, S. and Balcer, L. J. and Calabresi, P. A. and Cohen, J. A. and Cole, P. E. and Glanzman, R. and Goelz, S. and Inglese, M. and Kapoor, R. and Kappos, L. and Kreitman, R. and Lublin, F. D. and Mann, A. and Marrie, R. A. and O'Looney, P. and Polman, C. H. and Ravina, B. M. and Reingold, S. C. and Richert, J. R. and Sandrock, A. W. and Waubant, E.. (2009) Proof of concept studies for tissue-protective agents in multiple sclerosis. Multiple Sclerosis Journal, 15 (5). pp. 542-546.

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Official URL: http://edoc.unibas.ch/dok/A6007261

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Abstract

BACKGROUND: There is considerable interest in tissue-protective treatments for multiple sclerosis (MS). METHODS AND OBJECTIVES: We convened a group of MS clinical trialists and related researchers to discuss designs for proof of concept studies utilizing currently available data and assessment methods. RESULTS: Our favored design was a randomized, double-blind, parallel-group study of active treatment versus placebo focusing on changes in brain volume from a post-baseline scan (3-6 months after starting treatment) to the final visit 1 year later. Study designs aimed at reducing residual deficits following acute exacerbations are less straightforward, depending greatly on the anticipated rapidity of treatment effect onset. CONCLUSIONS: The next step would be to perform one or more studies of potential tissue-protective agents with these designs in mind, creating the longitudinal data necessary to refine endpoint selection, eligibility criteria, and sample size estimates for future trials.
Faculties and Departments:03 Faculty of Medicine > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
03 Faculty of Medicine > Departement Klinische Forschung > Bereich Medizinische Fächer (Klinik) > Neurologie > Neuroimmunologie (Kappos)
UniBasel Contributors:Kappos, Ludwig
Item Type:Article, refereed
Article Subtype:Further Journal Contribution
Bibsysno:Link to catalogue
Publisher:SAGE
ISSN:1352-4585
e-ISSN:1477-0970
Note:Publication type according to Uni Basel Research Database: Journal item
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Last Modified:02 Nov 2017 13:39
Deposited On:18 Jul 2014 09:10

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