A Phase II, randomized controlled trial of recombinant human Growth Hormone (rhGH) following rehabilitation for Traumatic Brain Injury

Project Type
Independent
Principal Investigator Name
Ramon Diaz-Arrastia, MD, PhD
Principal Investigator Email
Start Date:
1/30/2008
End Date:
9/30/2012
Participating Centers:
Target Population(s):
Patients 16-65 years of age who have suffered at TBI
Abstract:
This treatment study is a double-blind, placebo controlled trial designed to determine if treatment with recombinant human growth hormone (rhGH) in the sub-acute period after TBI results in improved functional outcome after injury and to determine if: treatment with rhGH results in increased IGF-1 levels; benefits of rhGH treatments persists up to 1 year after injury; low GH response to L-arginine stimulations at baseline is associated with poor functional outcome; low IGF-1 levels at baseline are associated with poor functional outcomes; rhGH treatment is more effective in patients who have low GH response to L-Arginine stimulation at baseline; and if rhGH treatment is more effective in patients who have low IGF-1 levels at baseline.