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, Robert PascuzziE. Pioro, L. J. Sams, S. Scelsa, E. P. Simpson, S. H. Subramony, E. Tiryaki, C. A. Thornton

Research output: Contribution to journalArticle

177 Citations (Scopus)

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

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Amyotrophic Lateral Sclerosis
Insulin-Like Growth Factor I
Outcome Assessment (Health Care)
Placebos
Intention to Treat Analysis
Tracheostomy
Survival Rate
Body Weight
Clinical Trials
Muscles
Therapeutics

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Sorenson, E. J., Windbank, A. J., Mandrekar, J. N., Bamlet, W. R., Appel, S. H., Armon, C., ... 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

Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. / 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.; Pascuzzi, Robert; Pioro, E.; Sams, L. J.; Scelsa, S.; Simpson, E. P.; Subramony, S. H.; Tiryaki, E.; Thornton, C. A.

In: Neurology, Vol. 71, No. 22, 25.11.2008, p. 1770-1775.

Research output: Contribution to journalArticle

Sorenson, EJ, Windbank, AJ, Mandrekar, JN, Bamlet, WR, Appel, SH, Armon, C, Barkhaus, PE, Bosch, P, Boylan, K, David, WS, Feldman, E, Glass, J, Gutmann, L, Katz, J, King, W, Luciano, CA, McCluskey, LF, Nash, S, Newman, DS, Pascuzzi, R, Pioro, E, Sams, LJ, Scelsa, S, Simpson, EP, Subramony, SH, Tiryaki, E & Thornton, CA 2008, 'Subcutaneous IGF-1 is not beneficial in 2-year ALS trial', Neurology, vol. 71, no. 22, pp. 1770-1775. https://doi.org/10.1212/01.wnl.0000335970.78664.36
Sorenson EJ, Windbank AJ, Mandrekar JN, Bamlet WR, Appel SH, Armon C et al. Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. Neurology. 2008 Nov 25;71(22):1770-1775. https://doi.org/10.1212/01.wnl.0000335970.78664.36
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. ; Pascuzzi, Robert ; Pioro, E. ; Sams, L. J. ; Scelsa, S. ; Simpson, E. P. ; Subramony, S. H. ; Tiryaki, E. ; Thornton, C. A. / Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. In: Neurology. 2008 ; Vol. 71, No. 22. pp. 1770-1775.
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AU - Sorenson, E. J.

AU - Windbank, A. J.

AU - Mandrekar, J. N.

AU - Bamlet, W. R.

AU - Appel, S. H.

AU - Armon, C.

AU - Barkhaus, P. E.

AU - Bosch, P.

AU - Boylan, K.

AU - David, W. S.

AU - Feldman, E.

AU - Glass, J.

AU - Gutmann, L.

AU - Katz, J.

AU - King, W.

AU - Luciano, C. A.

AU - McCluskey, L. F.

AU - Nash, S.

AU - Newman, D. S.

AU - Pascuzzi, Robert

AU - Pioro, E.

AU - Sams, L. J.

AU - Scelsa, S.

AU - Simpson, E. P.

AU - Subramony, S. H.

AU - Tiryaki, E.

AU - Thornton, C. A.

PY - 2008/11/25

Y1 - 2008/11/25

N2 - 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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