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Neurology ; 71(22): 1770-5, 2008 Nov 25.
Article in English | MEDLINE | ID: mdl-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.


Subject(s)
Amyotrophic Lateral Sclerosis/drug therapy , Amyotrophic Lateral Sclerosis/physiopathology , Central Nervous System Agents/administration & dosage , Insulin-Like Growth Factor I/administration & dosage , Central Nervous System Agents/adverse effects , Deglutition , Double-Blind Method , Female , Hand Strength , Humans , Injections, Subcutaneous , Insulin-Like Growth Factor I/adverse effects , Kaplan-Meier Estimate , Male , Middle Aged , Research Design , Thromboembolism/chemically induced , Time Factors , Tracheostomy , Treatment Failure
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