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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.
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.
Footnotes
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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.
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