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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: Active Phase 1 study of Gulf War Illness, sponsored by Nova Southeastern University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety is assessed by the incidence and severity of adverse events, by relation to the study intervention.
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 |
What the registry record for NCT04254627 still lists
NCT04254627 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 128-participant average among 14 other Gulf War Illness trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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
Similar trials for Gulf War Illness
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 NCT04254627's enrollment target sits among peer trials
20 15th of 14 the lowest of 14 other Gulf War Illness trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gulf War Illness 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
-
Confirmation of Diet as a Treatment for Gulf War Illness
RECRUITING · Phase 3
-
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
RECRUITING
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Validating Gulf War Illness Blood Biomarkers
RECRUITING
-
Nicotinamide Riboside Clinical Trial for GWI
RECRUITING · NA
-
Ca-Mg Butyrate in GWI
RECRUITING · Phase 2
-
Mechanisms of Gulf War Illness
RECRUITING · NA
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