Subcutaneous IGF-1 is not beneficial in 2-year ALS trial Academic Article uri icon

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  • 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.


  • Sorenson, EJ
  • Windbank, AJ
  • Mandrekar, JN
  • Bamlet, WR
  • Appel, SH
  • Armon, C
  • Barkhaus, PE
  • Bosch, P
  • Boylan, Khrista
  • David, WS
  • Feldman, E
  • Glass, J
  • Gutmann, L
  • Katz, J
  • King, W
  • Luciano, CA
  • McCluskey, LF
  • Nash, S
  • Newman, DS
  • Pascuzzi, RM
  • Pioro, E
  • Sams, LJ
  • Scelsa, S
  • Simpson, EP
  • Subramony, SH
  • Tiryaki, E
  • Thornton, CA

publication date

  • November 25, 2008

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