TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset (NCT04254627) | Clinical Trial Compass
Active — Not RecruitingPhase 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 range45 Years – 70 Years
SexMALE
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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.
✕. Able to provide consent to study,
✕. Subjects of childbearing potential must practice effective contraception during the study, and be willing to continue contraception for at least 6 months after intervention.
✕. 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.