Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult … (NCT04867317) | Clinical Trial Compass
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
United States172 participantsStarted 2025-01-13
Plain-language 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).
Who can participate
Age range
21 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. OEF/OIF/OND Veteran
. Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
. Age 21 - 55 years old
. One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.
. GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), or glucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/L for BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDS at baseline
. Score of 11 or more on QoL-AGHDA
. 4-week stability on any psychotropic medications
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial specifically for veterans with both mild traumatic brain injury and adult growth hormone deficiency — how would my doctor confirm whether I actually meet both of those diagnoses before we consider this study?
2The trial is measuring quality of life as its main outcome using a tool called the QoL-AGHDA — what does that actually mean in practical terms, and what kinds of quality-of-life changes are they hoping to detect with growth hormone replacement?
3Since this is a Phase 3 trial, what does my doctor already know about the safety profile of growth hormone replacement therapy in people with brain injury histories, and are there risks I should be especially aware of?
4Growth hormone replacement therapy involves regular injections and follow-up testing — given the demands this trial might place on my schedule, does my doctor think the logistics are realistic for my situation compared to just pursuing standard treatment outside a trial?
5If I'm eligible, would my doctor recommend first trying standard care options for either the growth hormone deficiency or the TBI-related symptoms before enrolling in a research study like this one?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
QoL-AGHDA (Quality of Life-Assessment of Adult Growth Hormone in Adults)
. 3-month stability on all other hormone treatments
Exclusion criteria
. History of moderate or severe TBI
. History of neurologic disorder other than TBI with substantial impact on quality of life
. History of bipolar 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 Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months.
. Contraindication to rhGH therapy
. Acute medical illness, active infection, cancer or decompensated chronic medical illness
. Evidence of substance use disorder, -other than mild alcohol or cannabis use disorder-, or urine toxicology evidence of the use of an illicit drug (excluding cannabis), in the past 6 months. Nicotine use is allowed.
. Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memory and Malingering (TOMM).