CSP #2018 - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Who is this study for? Patients with Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
What treatments are being studied? Somatropin
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 55
Healthy Volunteers: f
View:

• 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) 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

• 3-month stability on all other hormone treatments

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

Locations
United States
Florida
Miami VA Healthcare System, Miami, FL
NOT_YET_RECRUITING
Miami
Georgia
Atlanta VA Medical and Rehab Center, Decatur, GA
RECRUITING
Decatur
Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
RECRUITING
Minneapolis
Texas
Michael E. DeBakey VA Medical Center, Houston, TX
RECRUITING
Houston
Washington
VA Puget Sound Health Care System Seattle Division, Seattle, WA
RECRUITING
Seattle
Contact Information
Primary
Deane V Walker, MHA BS AB
Deane.Walker@va.gov
(203) 937-3440
Backup
Michael T Wininger, PhD
michael.wininger@va.gov
(203) 932-5711
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2028-03-01
Participants
Target number of participants: 172
Treatments
Active_comparator: Growth Hormone Replacement Therapy
Recombinant Human Growth Hormone
Placebo_comparator: Placebo
Placebo
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov