TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset (NCT04254627) | Clinical Trial Compass
CompletedPhase 1
TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset
United States20 participantsStarted 2021-09-24
Plain-language 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.
Who can participate
Age range
45 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 45-70 years old,
. Male sex,
. In good health by medical history prior to 1990
Exclusion criteria
. Fatigue after exercise as predominant component (a history of exercise intolerance or exercise-induced worsening of symptoms)
. 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.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this was a Phase 1 trial focused mainly on safety, what do the results actually tell us about whether this TNF and glucocorticoid antagonist combination is safe, and is there any published data my doctor can review?
2This trial specifically targeted Gulf War Illness by trying to 'reset' the body's response using two different types of antagonists — how does my own symptom profile compare to the patients enrolled, and does that affect whether this approach might be worth pursuing?
3Because the trial was measuring biomarker changes as a primary outcome, what would those biomarker results mean for my care, and is there a Phase 2 trial planned that would actually test whether this treatment helps symptoms?
4Given that this study is now completed, are the results available yet, and if so, what did they show about the incidence and severity of adverse events in the participants?
5Before considering any experimental approach like this one, are there existing standard-of-care treatments for Gulf War Illness that I should try first, and how do those compare in terms of what's known about their safety and benefit?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention.
. Agrees to participate in follow-up visits.
. 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)
. Known allergy to mifepristone, misoprostol, or medicines that contain misoprostol, such as Cytotec or Arthrotec.