Journal article
Subcutaneous IGF-1 is not beneficial in 2-year ALS trial
Neurology, Vol.71(22), pp.1770-1775
2008
DOI: 10.1212/01.wnl.0000335970.78664.36
PMCID: PMC2617770
PMID: 19029516
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.
Details
- Title: Subtitle
- Subcutaneous IGF-1 is not beneficial in 2-year ALS trial
- Creators
- E. J SORENSON - Mayo Clinic, Rochester, MN, United StatesA. J WINDBANK - Mayo Clinic, Rochester, MN, United StatesE FELDMAN - University of Michigan Medical Center, Ann Arbor, United StatesJ GLASS - Emory University Medical Center, Atlanta, GA, United StatesL GUTMANN - West Virginia University Medical Center, Morgantown, United StatesJ KATZ - Forhes Norris MDA/ALS Research Center, San Francisco, CA, United StatesW KING - Ohio Stare University Medical Center, Columbus, United StatesC. A LUCIANO - University of Puerto Rico, San Juan, Puerto RicoL. F MCCLUSKEY - Penn Neurological Institute, Philadelphia, PA, United StatesS NASH - Ohio Stare University Medical Center, Columbus, United StatesD. S NEWMAN - Henry Ford Medical Center, Detroit, MI, United StatesR. M PASCUZZI - University of Indiana Medical Center, Indianapolis, United StatesJ. N MANDREKAR - Mayo Clinic, Rochester, MN, United StatesE PIORO - Cleveland Clinic, OH, United StatesL. J SAMS - University of Cincinnati, OH, United StatesS SCELSA - Beth Israel Medical Center, New York, NY, United StatesE. P SIMPSON - Methodist Hospital, Houston, TX, United StatesS. H SUBRAMONY - University of Mississippi Medical Center, Jackson, United StatesE TIRYAKI - Hennepin County Medical Center, Minneapolis, MN, United StatesC. A THORNTON - University of Rochester Medical Center, NY, United StatesW. R BAMLET - Mayo Clinic, Rochester, MN, United StatesS. H APPEL - Methodist Hospital, Houston, TX, United StatesC ARMON - Baystate Medical Center, Springfield, MA, United StatesP. E BARKHAUS - Medical College of Wisconsin, Milwaukee, United StatesP BOSCH - Mayo Clinic Arizona, Scottsdale, United StatesK BOYLAN - Mayo Clinic Jacksonville, FL, United StatesW. S DAVID - Hennepin County Medical Center, Minneapolis, MN, United States
- Resource Type
- Journal article
- Publication Details
- Neurology, Vol.71(22), pp.1770-1775
- Publisher
- Lippincott Williams & Wilkins; Hagerstown, MD
- DOI
- 10.1212/01.wnl.0000335970.78664.36
- PMID
- 19029516
- PMCID
- PMC2617770
- ISSN
- 0028-3878
- eISSN
- 1526-632X
- Language
- English
- Date published
- 2008
- Academic Unit
- Neurology
- Record Identifier
- 9984013162302771
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