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.
authors.affiliation: Department of Neurology, Mayo Clinic, 200 1st St. SW, Rochester, MN 55905, USA. sorenson.eric@mayo.edu
authors.forename: E J
authors.initials: EJ
authors.lastname: Sorenson
authors.forename: A J
authors.initials: AJ
authors.lastname: Windbank
authors.forename: J N
authors.initials: JN
authors.lastname: Mandrekar
authors.forename: W R
authors.initials: WR
authors.lastname: Bamlet
authors.forename: S H
authors.initials: SH
authors.lastname: Appel
authors.forename: C
authors.initials: C
authors.lastname: Armon
authors.forename: P E
authors.initials: PE
authors.lastname: Barkhaus
authors.forename: P
authors.initials: P
authors.lastname: Bosch
authors.forename: K
authors.initials: K
authors.lastname: Boylan
authors.forename: W S
authors.initials: WS
authors.lastname: David
authors.forename: E
authors.initials: E
authors.lastname: Feldman
authors.forename: J
authors.initials: J
authors.lastname: Glass
authors.forename: L
authors.initials: L
authors.lastname: Gutmann
authors.forename: J
authors.initials: J
authors.lastname: Katz
authors.forename: W
authors.initials: W
authors.lastname: King
authors.forename: C A
authors.initials: CA
authors.lastname: Luciano
authors.forename: L F
authors.initials: LF
authors.lastname: McCluskey
authors.forename: S
authors.initials: S
authors.lastname: Nash
authors.forename: D S
authors.initials: DS
authors.lastname: Newman
authors.forename: R M
authors.initials: RM
authors.lastname: Pascuzzi
authors.forename: E
authors.initials: E
authors.lastname: Pioro
authors.forename: L J
authors.initials: LJ
authors.lastname: Sams
authors.forename: S
authors.initials: S
authors.lastname: Scelsa
authors.forename: E P
authors.initials: EP
authors.lastname: Simpson
authors.forename: S H
authors.initials: SH
authors.lastname: Subramony
authors.forename: E
authors.initials: E
authors.lastname: Tiryaki
authors.forename: C A
authors.initials: CA
authors.lastname: Thornton
mesh_terms: D000690:Amyotrophic Lateral Sclerosis / Q000188:drug therapy* / Q000503:physiopathology*; D002491:Central Nervous System Agents / Q000008:administration & dosage* / Q000009:adverse effects; D003679:Deglutition; D004311:Double-Blind Method; D005260:Female; D018737:Hand Strength; D006801:Humans; D007279:Injections, Subcutaneous; D007334:Insulin-Like Growth Factor I / Q000008:administration & dosage* / Q000009:adverse effects; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012107:Research Design; D013923:Thromboembolism / Q000139:chemically induced; D013997:Time Factors; D014139:Tracheostomy; D017211:Treatment Failure
chemical_list: D002491:Central Nervous System Agents; D007334:Insulin-Like Growth Factor I