drugset / Trial / NCT04254627

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

NCT04254627

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-09-24
Primary completion
2025-09-30
Completion
2025-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mifepristone Small molecule 300 mg
Subject Mifepristone Small molecule 600 mg
Background Etanercept Protein / enzyme biologic 50 mg

Indications