MedTrace Logo

TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset

NCT04254627 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-02-19

No results posted yet for this 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

  • Gulf War Illness

Interventions

DRUG

Etanercept

Etanercept 50 mg weekly injection

DRUG

Mifepristone

Mifepristone 300 mg pill

Sponsors & Collaborators

  • RTI International

    collaborator OTHER

  • Miami VA Healthcare System

    collaborator FED

  • Nova Southeastern University

    lead OTHER

Principal Investigators

  • Nancy Klimas, MD · Miami VA Healthcare System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-24
Primary Completion
2025-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04254627 on ClinicalTrials.gov