Subcutaneous IGF-1 is not beneficial in 2-year ALS trial

E. J. Sorenson, A. J. Windbank, J. N. Mandrekar, W. R. Bamlet, S. H. Appel, C. Armon, P. E. Barkhaus, P. Bosch, K. Boylan, W. S. David, E. Feldman, J. Glass, L. Gutmann, J. Katz, W. King, C. A. Luciano, L. F. McCluskey, S. Nash, D. S. Newman, R. M. PascuzziE. Pioro, L. J. Sams, S. Scelsa, E. P. Simpson, S. H. Subramony, E. Tiryaki, C. A. Thornton

Research output: Contribution to journalArticle

185 Scopus citations

Abstract

Background: Previous human clinical trials of insulin-like growth factor type I (IGF-1) in amyotrophic lateral sclerosis (ALS) have been inconsistent. This phase III, randomized, double-blind, placebo-controlled study was undertaken to address whether IGF-1 benefited patients with ALS. Methods: A total of 330 patients from 20 medical centers were randomized to receive 0.05 mg/kg body weight of human recombinant IGF-1 given subcutaneously twice daily or placebo for 2 years. The primary outcome measure was change in their manual muscle testing score. Secondary outcome measures included tracheostomy-free survival and rate of change in the revised ALS functional rating scale. Intention to treat analysis was used. Results: There was no difference between treatment groups in the primary or secondary outcome measures after the 2-year treatment period. Conclusions: Insulin-like growth factor type I does not provide benefit for patients with amyotrophic lateral sclerosis.

Original languageEnglish (US)
Pages (from-to)1770-1775
Number of pages6
JournalNeurology
Volume71
Issue number22
DOIs
StatePublished - Nov 25 2008

ASJC Scopus subject areas

  • Clinical Neurology

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    Sorenson, E. J., Windbank, A. J., Mandrekar, J. N., Bamlet, W. R., Appel, S. H., Armon, C., Barkhaus, P. E., Bosch, P., Boylan, K., David, W. S., Feldman, E., Glass, J., Gutmann, L., Katz, J., King, W., Luciano, C. A., McCluskey, L. F., Nash, S., Newman, D. S., ... Thornton, C. A. (2008). Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. Neurology, 71(22), 1770-1775. https://doi.org/10.1212/01.wnl.0000335970.78664.36