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NCT04867317 · ClinicalTrials.gov registry record · Phase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
A Phase 3 study of Mild Traumatic Brain Injury and Adult Growth Hormone Deficiency, sponsored by VA Office of Research and Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 172
- Enrollment target
- 4
- Study locations
NCT04867317: Recruiting Phase 3 study of Mild Traumatic Brain Injury and Adult Growth Hormone Deficiency, sponsored by VA Office of Research and Development.
NCT04867317 is a Phase 3 study of Mild Traumatic Brain Injury and Adult Growth Hormone Deficiency that is actively recruiting participants, run by VA Office of Research and Development. The registered enrollment target is 172 participants, below the 217-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (21% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04867317, a Phase 3 study of Mild Traumatic Brain Injury and Adult Growth Hormone Deficiency, is actively recruiting participants, sponsored by VA Office of Research and Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 172 participants
- Enrollment target
- 4
- Study locations
Study 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).
Primary Outcome
25 question survey on quality of life; The primary objective of CSP #2018 is to determine the efficacy of rhGH, given daily for 6 months, versus placebo to improve QoL, as measured by difference in mean QoL-AGHDA score, among Veterans with a history of mTBI and AGHD (primary outcome). The primary hypothesis is that the investigators, compared to placebo, patients treated with rhGH will exhibit a 3.5-point lower mean score (higher quality of life) in QoL-AGHDA at 6 months. QoL-AGHDA: minimum scor
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Somatropin
Study Locations (4)
Georgia
- Atlanta VA Medical and Rehab Center, Decatur, GA - Decatur
Minnesota
- Minneapolis VA Health Care System, Minneapolis, MN - Minneapolis
Texas
- Michael E. DeBakey VA Medical Center, Houston, TX - Houston
Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2025-01-13 |
| Est. Completion | 2028-03-01 |
| Phase | Phase 3 |
What NCT04867317 shows while recruiting
NCT04867317 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 217-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (21% lower).
The record links to 2 conditions, with Mild Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04867317 reports a single indexed study location in Georgia, Minnesota, Texas.
Frequently Asked Questions
What is clinical trial NCT04867317 about?
NCT04867317 is a clinical study titled "Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)". 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).
What is the current status of trial NCT04867317?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 172 participants. The study started on 2025-01-13. Estimated completion is 2028-03-01.
What conditions does trial NCT04867317 study?
This clinical trial studies the following conditions: Mild Traumatic Brain Injury, Adult Growth Hormone Deficiency.
What interventions are being tested in trial NCT04867317?
The interventions under investigation include: Placebo (OTHER), Somatropin (DRUG).
Who is sponsoring clinical trial NCT04867317?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04867317 being conducted?
This trial has 4 study locations across Georgia, Minnesota, Texas, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Mild Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04867317's enrollment target sits among peer trials
172 11th of 43 higher than 33 of 43 other Mild Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Mild Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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