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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.

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Figure 1 Patient flow chart
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Figure 2 Kaplan-Meier survival curves, p = 0.415
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