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New treatment option for Adult Growth Hormone Deficiency
Official title Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
ClinicalTrials.gov ID: NCT04867317
What this study is testing
What is Somatropin?
Somatropin is an investigational medicine, being studied as a potential treatment for adult growth hormone deficiency.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 55
You may be able to join if
- 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...
You likely can't join if
- 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)...
- Contraindication to rhGH therapy
- Acute medical illness, active infection, cancer or decompensated chronic medical illness
See the full eligibility 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...
- 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.
- 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).
- BMI \> 40 or body weight \> 350 lbs
- Pituitary anatomy documented by an MRI using a sella protocol within the last 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, IGF-I, or chronic glucocorticoid use in supraphysiologic doses
- Currently enrolled in any other treatment study unless prior approval is provided by the study chairs and the study sponsor (Cooperative Studies Program)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- San Diego, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Decatur, Georgia, United States
- Ann Arbor, Michigan, United States
- Minneapolis, Minnesota, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
- Salisbury, North Carolina, United States
- Oklahoma City, Oklahoma, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- San Antonio, Texas, United States
- Seattle, Washington, United States
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; San Diego, California, United States; Aurora, Colorado, United States; Washington D.C., District of Columbia, United States; Decatur, Georgia, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.