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New drug cocktail aims to reset gulf war illness symptoms

NCT ID NCT04254627

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage study tested a combination of two drugs (etanercept and mifepristone) in 20 male veterans with Gulf War Illness. The goal was to see if the treatment is safe and can help reset the body's systems to reduce symptoms like fatigue, pain, and memory problems. Results will guide future larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

20 people

The number who actually took part.

Started

Sep 2021

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 to 70 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 45-70 years old, 2. Male sex, 3. In good health by medical history prior to 1990 4. Meets modified Kansas and CDC case definition criteria for Gulf War Illness. Original Kansas criteria and CDC case definitions, including their exclusionary conditions. The modified Kansas definition, which includes the CDC criteria, includes the following: 1. Fatigue after exercise as predominant component (a history of exercise intolerance or exercise-induced worsening of symptoms) 2. Allowance for normal illnesses of aging, such as hypertension and diabetes, if the conditions are treated and are in demonstrable stable and normal ranges at the time of screening and assessment. 3. Allowance of stable comorbid conditions such as PTSD, MDD, and TBI that have not required hospitalization in the 5 years prior to recruitment. Severe TBI is excluded. 5. Able to provide consent to study, 6. Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention. 7. Agrees to participate in follow-up visits. Exclusion Criteria: 1. Current treated or untreated major depression with psychotic or melancholic features, schizophrenia, bipolar disorder, delusional disorders, dementias of any type, and alcoholism or drug abuse (as determined by self-report, SAGE-SR, and Ham-D) 2. Known allergy to mifepristone, misoprostol, or medicines that contain misoprostol, such as Cytotec or Arthrotec. 3. Current heavy alcohol or tobacco use (self-report). Alcohol consumption not to exceed approximately 15 drinks per week (with a drink defined as 12 oz beer, 5 oz wine, or 1.5 oz distilled spirits) and tobacco use not to exceed 20 cigarettes (or equivalent) per day. 4. Current organ failure (as determined by metabolic panel and self-report) 5. Current treated or untreated rheumatologic and inflammatory disorders, as determined by medical diagnosis of one or more of the following: osteoarthritis, rheumatoid arthritis (RA), lupus, spondyloarthropathies -- ankylosing spondylitis (AS) and psoriatic arthritis (PsA), Sjogren's syndrome, gout, scleroderma, infectious arthritis, and polymyalgia rheumatic 6. Chronic active infections such as HIV, hepatitis B, and hepatitis C (as determined by antibody tests 7. History of organ transplant (self-report) 8. Current untreated primary sleep disorders such as insomnias, sleep related breathing disorders, etc. (self-report) 9. History of tuberculosis exposure (determined by QuantiFERON-TB® positivity) 10. Use of medications that could affect immune function (e.g., steroids, immunosuppressants) or limit the interpretation of the exercise challenge (self- report) 11. Renal disease (self-report; laboratory results: renal insufficiency with serum creatinine \> 2.0 mg/dL or eGFR \< 44; or currently on renal dialysis). 12. Hepatic insufficiency (bilirubin \>2.5mg/dL or transaminases \>5x the ULN) Subjects with Gilberts syndrome are eligible for the study if other liver function tests are normal, regardless of bilirubin level. 13. Currently have no exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity, using the exclusion criteria best described in the Ambiguities in case definition paper for Chronic Fatigue Syndrome (CFS) which clarifies exclusionary conditions. 14. Are scheduled for surgery within 24 weeks of study enrollment. 15. Cushing's disease or salivary cortisol level greater than 0.812 ug/dL. 16. QT prolongation, as evidenced by medical history (self-report) or ECG at screening. 17. Uncontrolled diabetes (A1c\>7.5). Prohibited concomitant or prior therapies: 1. Immunosuppressant drugs, including glucocorticoid taper, topical/inhaled glucocorticoids 2. Currently on dialysis 3. Recipient of bone marrow or organ transplant 4. Previous or current treatment with angiogenic growth factors, cytokines, gene or stem cell therapy 5. Participating in another interventional clinical trial of an investigational therapy within 8 weeks prior to consent to participate in this study, or planning to participate in another interventional clinical trial of an investigational therapy within 26 weeks after consent to participate in this study 6. Any herbal medicine that contains licorice root. 7. Selective Blood thinners: * Only Apixaban and Warfarin will be included. Rivaroxaban cannot be included as there are higher drug to drug interactions as well as Apixaban 2.5 mg BID. * If a participant is on Warfarin, a baseline INR will be obtained, the Warfarin dose will be reduced and an INR will be rechecked 48-72 hours after starting Mifepristone. * If a participant is on Apixaban, the dose must be reduced by 50%. * Please note that if participants are taking anticoagulants, there is a potential interaction that could lead to possible increased on risk of bleeding and will require more frequent monitoring by the Coordinator.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Miami VA Healthcare System

    Miami, Florida, 33125, United States

  • Nova Southeastern University

    Davie, Florida, 33314, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.