Subcutaneous IGF-1 is not beneficial in 2-year ALS trial. Neurology 2008 Nov 25;71(22):1770-5
Date
11/26/2008Pubmed ID
19029516Pubmed Central ID
PMC2617770DOI
10.1212/01.wnl.0000335970.78664.36Scopus ID
2-s2.0-58149242839 (requires institutional sign-in at Scopus site) 216 CitationsAbstract
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 List
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 CAAuthor
Paul E. Barkhaus MD Professor in the Neurology department at Medical College of WisconsinMESH terms used to index this publication - Major topics in bold
Amyotrophic Lateral SclerosisCentral Nervous System Agents
Deglutition
Double-Blind Method
Female
Hand Strength
Humans
Injections, Subcutaneous
Insulin-Like Growth Factor I
Kaplan-Meier Estimate
Male
Middle Aged
Research Design
Thromboembolism
Time Factors
Tracheostomy
Treatment Failure
