drugset / Trial / NCT04254627
TNF and Glucocorticoid Antagonist for GWI Associated Multi-symptom Disease Homeostasis Reset
Phase 1
Completed
20 enrolled
Nova Southeastern University
Miami VA Healthcare System · collabRTI International · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mifepristone | Small molecule | 300 mg | — |
| Subject | Mifepristone | Small molecule | 600 mg | — |
| Background | Etanercept | Protein / enzyme biologic | 50 mg | — |