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. Pascuzzi; E. Pioro; L. J. Sams; S. Scelsa; E. P. Simpson; S. H. Subramony; E. Tiryaki; C. A. Thornton

doi:10.1212/01.wnl.0000335970.78664.36

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 journal › Article › peer-review

193 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 language	English (US)
Pages (from-to)	1770-1775
Number of pages	6
Journal	Neurology
Volume	71
Issue number	22
DOIs	https://doi.org/10.1212/01.wnl.0000335970.78664.36
State	Published - Nov 25 2008

ASJC Scopus subject areas

Clinical Neurology

Access to Document

10.1212/01.wnl.0000335970.78664.36

Cite this

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

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, RM, 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

@article{b4d940ff344d4303b3c9884b66c7b668,

title = "Subcutaneous IGF-1 is not beneficial in 2-year ALS trial",

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.",

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

note = "Funding Information: Supported by NIH grant # RO1 NS 42759 and by a grant from the ALS Association. ",

year = "2008",

month = nov,

day = "25",

doi = "10.1212/01.wnl.0000335970.78664.36",

language = "English (US)",

volume = "71",

pages = "1770--1775",

journal = "Neurology",

issn = "0028-3878",

publisher = "Lippincott Williams and Wilkins",

number = "22",

}

TY - JOUR

T1 - Subcutaneous IGF-1 is not beneficial in 2-year ALS trial

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, R. M.

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.

N1 - Funding Information: Supported by NIH grant # RO1 NS 42759 and by a grant from the ALS Association.

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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=58149242839&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=58149242839&partnerID=8YFLogxK

U2 - 10.1212/01.wnl.0000335970.78664.36

DO - 10.1212/01.wnl.0000335970.78664.36

M3 - Article

C2 - 19029516

AN - SCOPUS:58149242839

SN - 0028-3878

VL - 71

SP - 1770

EP - 1775

JO - Neurology

JF - Neurology

IS - 22

ER -

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

Abstract

ASJC Scopus subject areas

Access to Document

Other files and links

Fingerprint

Cite this