AGH Replacement Therapy With mTBI

• Status: Not yet recruiting
• Trial end date: 2025-09-30
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: VA Office of Research and Development

Criteria

Inclusion Criteria:

• OEF/OIF/OND Veteran

• Score of 1 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)

• One or more TBI on Military-specific sub-domains of Boston Assessment of Traumatic Brain Injury-Lifetime (BAT-L)

• GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L)

• Score of 11 or more on QoL-AGHDA

• 4-week stability on any psychotropic medications

• 3-month stability on all other hormone treatments

• Able and willing to provide informed consent to participate in this study, and complete study protocol

Exclusion Criteria:

• History of moderate or severe TBI

• History of neurologic disorder other than TBI with substantial impact on quality of life

• History of bi-polar disorder, schizophrenia, or other concurrent psychotic disorder

• Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months Contraindication to rhGH therapy

• Contraindication to macimorelin use

• Acute medical illness, active infection, cancer or decompensated chronic medical illness

• Evidence of substance abuse disorder in the past 6 months other than mild alcohol or cannabis use disorder; nicotine use is allowed

• Urine toxicology evidence of the use of an illicit drug, excluding cannabis, within the past 90 days prior to screening

• Scoring less than 41 on Trial I of the Test of Memory and Malingering (TOMM) BMI >35 or body weight >350 lbs

• Pituitary anatomy documented by an MRI using a sella protocol within the past 2 years indicating abnormalities consistent with an etiology other than mild-TBI

• i.e., pituitary mass

• Women who are pregnant or of child-bearing potential not on contraception

• Current use of the following: growth hormone, estrogen or estrogen-like dietary supplements, progestin, IGH-I, or chronic glucocorticoid use in supraphysiologic doses

• Currently enrolled in any other interventional study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)