Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
Status:
Completed
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
Growth Hormone (GH) deficiency, defined by insufficient GH response to a variety of
stimulating compounds, is found in 20-35% of adults who suffer traumatic brain injuries (TBI)
requiring inpatient rehabilitation1. However, there is no accepted gold standard for
diagnosing GH deficiency in this population. Further, the major effector molecule of the
somatotropic axis, Insulin-Like Growth Factor-1 (IGF-1) has recently been recognized as an
important neurotrophic agent. Since most repair and regeneration after TBI occurs within the
first few months after injury, absolute or relative deficiencies of GH and IGF-1 in the
subacute period after TBI are potentially important factors why some patients fail to make a
good functional recovery. The proposed study is a randomized, double-blind,
placebo-controlled trial of rhGH, starting at 1 month post TBI, continuing for 6 months.
This study has one primary hypothesis, that treatment with recombinant human Growth Hormone
(rhGH) in the subacute period after TBI results in improved functional outcome 6 months after
injury. As secondary hypotheses, we will investigate what is the optimal method to diagnose
GH deficiency in TBI survivors and study the relationship between GH deficiency and
insufficiency and functional recovery.
Phase:
Phase 2
Details
Lead Sponsor:
University of Pennsylvania University of Texas Southwestern Medical Center