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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 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.

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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).

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

FieldValue
Enrollment Target 172 participants
Start Date 2025-01-13
Est. Completion 2028-03-01
Phase Phase 3

Sponsor

VA Office of Research and Development

1,668 total trials

What the Registry Record Tells You About NCT04867317

The ClinicalTrials.gov registry entry for NCT04867317 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 43 other Mild Traumatic Brain Injury trials with a reported enrollment target (21% lower). The listed sponsor is VA Office of Research and Development, which has 1,668 total studies on file at ClinicalTrials.gov.

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 4 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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