Sample size estimations for MRI-monitored trials of MS comparing new vs standard treatments

M. P. Sormani, M. Rovaris, F. Bagnato, P. Molyneux, P. Bruzzi, C. Pozzilli, D. H. Miller, G. Comi, M. Filippi

Research output: Contribution to journalArticle

Abstract

The authors estimated the sample sizes needed for exploratory trials of MS assessing the efficacy of new treatments in reducing the number of new enhancing lesions vs those of interferon-β or glatiramer acetate. The sample sizes per arm ranged from 868 (effect: 20%) to 94 (effect: 50%) for patients with relapsing-remitting MS and from 2,484 (effect: 20%) to 361 (effect: 50%) for patients with secondary progressive MS. In MS, exploratory trials of new vs available therapies require large numbers of patients, even when MR end-points are used.

Original languageEnglish
Pages (from-to)1883-1885
Number of pages3
JournalNeurology
Volume57
Issue number10
Publication statusPublished - Nov 27 2001

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ASJC Scopus subject areas

  • Neuroscience(all)

Cite this

Sormani, M. P., Rovaris, M., Bagnato, F., Molyneux, P., Bruzzi, P., Pozzilli, C., Miller, D. H., Comi, G., & Filippi, M. (2001). Sample size estimations for MRI-monitored trials of MS comparing new vs standard treatments. Neurology, 57(10), 1883-1885.