Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by The University of Texas, Galveston
Sponsor:
Collaborator:
The Moody Foundation
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00957671
First received: August 10, 2009
Last updated: May 22, 2014
Last verified: May 2014

August 10, 2009
May 22, 2014
November 2003
December 2015   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00957671 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury
Anterior Pituitary Hormone Replacement in Traumatic Brain Injury

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Growth Hormone Deficiency
  • Traumatic Brain Injury
  • Drug: 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)
  • Drug: Placebo
    Inert agent given in same manner as active drug for control purposes
  • Active Comparator: Human Growth Hormone
    Growth hormone administered daily for one year
    Intervention: Drug: Human Growth Hormone
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2015
December 2015   (final data collection date for primary outcome measure)

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.
Both
21 Years and older
No
Contact: Jack Foreman (800) 852-4769 ext 448 jforeman@tlcgalveston.org
Contact: Charles R. Gilkison, RN, MSN (409) 772-2065 cgilkiso@utmb.edu
United States
 
NCT00957671
03-034
No
The University of Texas, Galveston
The University of Texas, Galveston
The Moody Foundation
Principal Investigator: Randall J Urban, M.D. The University of Texas Medical Branch at Galveston
The University of Texas, Galveston
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP