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NCT04254627 · ClinicalTrials.gov registry record · Phase 1
TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset
A Phase 1 study of Gulf War Illness, sponsored by Nova Southeastern University.
- Active
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 2
- Study locations
NCT04254627 is a Phase 1 study of Gulf War Illness that is active but no longer recruiting, run by Nova Southeastern University. The registered enrollment target is 20 participants, below the 128-participant average among 14 other Gulf War Illness trials with a reported enrollment target (84% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT04254627, a Phase 1 study of Gulf War Illness, is active but no longer recruiting, sponsored by Nova Southeastern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 2
- Study locations
Study Summary
Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase I single-site, open-label two-arm study will assess the safety and mechanistic efficacy of a sequential etanercept-mifepristone intervention for Gulf War Illness. The results of this phase I study will be compared to those from an existing short-duration study to identify the optimal duration and dosage for use in a future phase II study.
Conditions Studied
Interventions
- DRUG Mifepristone
- DRUG Etanercept
Study Locations (2)
Florida
- Nova Southeastern University - Davie
- Miami VA Healthcare System - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2021-09-24 |
| Est. Completion | 2025-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04254627
The ClinicalTrials.gov registry entry for NCT04254627 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 128-participant average among 14 other Gulf War Illness trials with a reported enrollment target (84% lower). The listed sponsor is Nova Southeastern University, which has 71 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gulf War Illness appearing as the primary indexed condition, and to 2 interventions - of which Mifepristone is the first listed.
NCT04254627 reports 2 study locations spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04254627 about?
NCT04254627 is a clinical study titled "TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset". Gulf War Illness is a condition that affects multiple major organ systems, resulting in a diverse array of symptoms that include debilitating fatigue, memory and cognition difficulties, headaches, sleep disturbances, gastrointestinal problems, skin rashes, and musculoskeletal/joint pain. This phase ...
What is the current status of trial NCT04254627?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2021-09-24. Estimated completion is 2025-09.
What conditions does trial NCT04254627 study?
This clinical trial studies the following conditions: Gulf War Illness.
What interventions are being tested in trial NCT04254627?
The interventions under investigation include: Mifepristone (DRUG), Etanercept (DRUG).
Who is sponsoring clinical trial NCT04254627?
This trial is sponsored by Nova Southeastern University, which has 71 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04254627 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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-
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.