Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2008 Nov 25;71(22):1770-5.
doi: 10.1212/01.wnl.0000335970.78664.36.

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

E J Sorenson  1 , 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 Pascuzzi, E Pioro, L J Sams, S Scelsa, E P Simpson, S H Subramony, E Tiryaki, C A Thornton
Affiliations
Clinical Trial

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

E J Sorenson et al. Neurology. .

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.

PubMed Disclaimer

Figures

None
Figure 1 Patient flow chart
None
Figure 2 Kaplan-Meier survival curves, p = 0.415
See this image and copyright information in PMC

Comment in

References

    1. Corse AM, Bilak MM, Bilak SR, Lehar M, Rothstein JD, Kuncl RW. Preclinical testing of neuroprotective neurotrophic factors in a model of chronic motor neuron degeneration. Neurobiol Dis 1999;6:335–346. - PubMed
    1. Vergani L, Losa M, Lesma E, et al. Glycosaminoglycans boost insulin-like growth factor-I-promoted neuroprotection: blockade of motor neuron death in the wobbler mouse. Neuroscience 1999;93:565–572. - PubMed
    1. Vergani L, Finco C, Di Giulio AM, Muller EE, Gorio A. Effects of low doses of glycosaminoglycans and insulin-like growth factor-I on motor neuron disease in wobbler mouse. Neurosci Lett 1997;228:41–44. - PubMed
    1. Borasio GD, Robberecht W, Leigh PN, et al. A placebo-controlled trial of insulin-like growth factor-I in amyotrophic lateral sclerosis. European ALS/IGF-I Study Group. Neurology 1998;51:583–586. - PubMed
    1. Lai EC, Felice KJ, Festoff BW, et al. Effect of recombinant human insulin-like growth factor-I on progression of ALS: a placebo-controlled study. The North America ALS/IGF-I Study Group.Neurology 1997;49:1621–1630. - PubMed

Publication types

MeSH terms

Substances