Overview

This trial is active, not recruiting.

Conditions growth hormone deficiency, traumatic brain injury
Treatments human growth hormone, placebo
Phase phase 4
Sponsor The University of Texas, Galveston
Collaborator The Moody Foundation
Start date November 2003
End date December 2016
Trial size 400 participants
Trial identifier NCT00957671, 03-034

Summary

Fifteen to twenty percent of adults who suffer a traumatic brain injury (TBI) that requires hospitalization and rehabilitation have been found to have growth hormone (GH) deficiency by GH stimulation testing. Moreover, abnormalities have also been established for the cortisol and thyroid axis. The hypothesis of this proposal is that hormone replacement in TBI patients with documented abnormalities in the GH, thyroid, or cortisol axis will improve muscle function, body composition, aerobic capacity (GH) and tests of neuropsychologic function (GH, thyroid, cortisol).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Growth hormone administered daily for one year
human growth hormone
200 mcg daily for two months, followed by 400 mcg daily for two months followed by 600 mcg daily for term of treatment period (one year total)
(Placebo Comparator)
placebo
Inert agent given in same manner as active drug for control purposes

Primary Outcomes

Measure
Determine the effect of recombinant human growth hormone (rhGH) replacement on neuropsychologic function in individuals with growth hormone deficiency following traumatic brain injury
time frame: One year

Secondary Outcomes

Measure
Determine the effect of recombinant human growth hormone (rhGH) replacement on muscle function function in individuals with growth hormone deficiency following traumatic brain injury
time frame: One year
Determine the effect of recombinant human growth hormone (rhGH) replacement on body composition in individuals with growth hormone deficiency following traumatic brain injury
time frame: One year
Determine the effect of recombinant human growth hormone (rhGH) replacement on aerobic capacity in individuals with growth hormone deficiency following traumatic brain injury
time frame: One year

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Patients aged 21 and older. - Documented moderate to severe traumatic brain injury at least one year post injury. Exclusion Criteria: - The only absolute exclusionary medication will be an anticoagulant (Coumadin) because of the risk of bleeding during the possible muscle biopsy procedure and daily injections of rhGH in the GH arm of the study. - Any subject with a history of hepatitis or a 3-fold elevation of liver function tests (Alk phos, alanine aminotransferase (ALT), aspartate aminotransferase (AST)). We are uncertain of the effects of hormone replacement such as rhGH on the liver, so we will exclude any subjects with hepatitis. This exclusion applies only to subjects who would be enrolled in the GH arm of the study. - Subjects who are deficient in cortisol or thyroid at screening will be excluded until hormone abnormalities have been corrected. - Subjects with chronic pain who are being managed with narcotics will be excluded as the effects of central nervous system depressants may interfere with study test results.

Additional Information

Official title Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Principal investigator Randall J Urban, M.D.
Description This protocol is designed to screen and detect evidence of pituitary hormone deficiency in adults following traumatic brain injury. Treatment period for thyroid or cortisol deficiency will be six months. Growth hormone deficiency will be replaced for a period of one year followed by a second year of open label treatment to allow individuals in the placebo group an opportunity to demonstrate a response to hormone replacement. Subject will not be screened until at least one year following brain injury to allow for natural recovery of hormone function.
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by The University of Texas, Galveston.