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NEUROLOGY 2008;71:1770-1775
© 2008 American Academy of Neurology

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

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

From the Mayo Clinic (E.J.S., A.J.W., J.N.M., W.R.B.), Rochester, MN; Methodist Hospital (S.H.A., E.P.S.), Houston, TX; Baystate Medical Center (C.A.), Springfield, MA; Medical College of Wisconsin (P.E.B.), Milwaukee; Mayo Clinic Arizona (P.B.), Scottsdale; Mayo Clinic Jacksonville (K.B.), FL; Hennepin County Medical Center (W.S.D., E.T.), Minneapolis, MN; University of Michigan Medical Center (E.F.), Ann Arbor; Emory University Medical Center (J.G.), Atlanta, GA; West Virginia University Medical Center (L.G.), Morgantown; Forbes Norris MDA/ALS Research Center (J.K.), San Francisco, CA; Ohio State University Medical Center (W.K., S.N.), Columbus; University of Puerto Rico (C.A.L.), San Juan; Penn Neurological Institute (L.F.M.), Philadelphia, PA; Henry Ford Medical Center (D.S.N.), Detroit, MI; University of Indiana Medical Center (R.M.P.), Indianapolis; Cleveland Clinic (E.P.), OH; University of Cincinnati (L.J.S.), OH; Beth Israel Medical Center (S.S.), New York, NY; University of Mississippi Medical Center (S.H.S.), Jackson; and University of Rochester Medical Center (C.A.T.), NY.

Address correspondence and reprint requests to Dr. Eric J. Sorenson, Department of Neurology, Mayo Clinic, 200 1st St. SW, Rochester, MN 55905 sorenson.eric{at}mayo.edu

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.

GLOSSARY: ALS = amyotrophic lateral sclerosis; ALSFRS-r = revised ALS functional rating scale; AUC = area under the curve; DVT = deep venous thromboses; IGF-1 = insulin-like growth factor type I; MMT = manual muscle testing; PE = pulmonary embolisms.

Supported by NIH grant # RO1 NS 42759 and by a grant from the ALS Association.

Disclosure: The authors report no disclosures.

Received June 3, 2008. Accepted in final form August 25, 2008.




Correspondence:

Read all Correspondence

Subcutaneous IGF-1 is not beneficial in 2-year ALS trial
Charles L. Howe, et al.
Neurology Online, 23 Feb 2009 [Full text]
Reply from the authors
Eric J. Sorenson, et al.
Neurology Online, 23 Feb 2009 [Full text]

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