Gulf War Illness Clinical Trial
Official title:
Tumor Necrosis Factor (TNF) and Glucocorticoid Antagonist for Gulf War Illness (GWI)-Associated Multi-symptom Disease Homeostasis Reset
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.
This is a study in male Veterans 45-70 years of age who meet the modified Kansas and Centers for Disease Control and Prevention (CDC) criteria for GWI (Gulf War Illness) and have high physiologic stress. This phase I single-site, open-label, two-arm study will focus on optimizing the dosage of a sequential etanercept-mifepristone intervention for GWI. Twenty participants will be assessed at baseline, 6, 12, 13, 16 and 24 weeks. The investigators will use systems biology methods to perform computational modelling of physiological responses to supervised maximal exercise challenge studies on a fitness bicycle at baseline and 24 weeks. These analyses will assess the impact of the treatment on homeostatic networks: the changes in levels of physiological parameters and the changes in inter-correlations among the measured parameters (e.g., cytokines), cross-sectionally and over time. Participants will also undergo subjective assessments of functional health, symptom severity, pain, fatigue, and cognition at baseline, 6, 12, 13, 16, and 24 weeks. Participants will be observed through the treatment period and for 3 months after completion to assess immediate effects and durability of the response. 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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02011542 -
Probiotic (VSL #3) for Gulf War Illness
|
Phase 2/Phase 3 | |
Recruiting |
NCT03078530 -
Probiotic (Visbiome) for Gulf War Illness
|
Phase 2/Phase 3 | |
Recruiting |
NCT04058275 -
"Immunomodulation in GWI (Phlebotomy)"
|
||
Recruiting |
NCT04255498 -
Understanding GWI: Integrative Modeling
|
Phase 1 | |
Completed |
NCT02782780 -
Cognitive Behavioral Therapy for Insomnia for Gulf War Illness
|
N/A | |
Recruiting |
NCT02983734 -
D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)
|
Phase 2 | |
Recruiting |
NCT05972291 -
Mechanisms of Gulf War Illness
|
N/A | |
Recruiting |
NCT04182659 -
Long Term Efficacy of Neuronavigation Guided rTMS in Alleviating Gulf War Illness Related Headaches and Pain Symptoms
|
N/A | |
Recruiting |
NCT04046536 -
rTMS in Alleviating Pain and Co-Morbid Symptoms in Gulf War Veterans Illness (GWVI)
|
N/A | |
Recruiting |
NCT05377242 -
Curcumin, Resveratrol, and Stinging Nettle as Treatments for GWI
|
N/A | |
Recruiting |
NCT05675878 -
Confirmation of Diet as a Treatment for Gulf War Illness
|
Phase 3 | |
Recruiting |
NCT05736146 -
Validating Gulf War Illness Blood Biomarkers
|
||
Not yet recruiting |
NCT05820893 -
Resistant Potato Starch to Alleviate GWI
|
Phase 2 | |
Terminated |
NCT01846182 -
Research Examining Gulf War Illness in Our Nations Service Members
|
Phase 2 | |
Active, not recruiting |
NCT05252949 -
OEA for Targeting Lipid Metabolism in GWI
|
N/A | |
Completed |
NCT02378025 -
Treating Chronic Pain in Gulf War Illness
|
N/A | |
Completed |
NCT02865460 -
Coenzyme Q10 Phase III Trial in Gulf War Illness
|
Phase 3 | |
Completed |
NCT02909686 -
Effects of Botanical Microglia Modulators in Gulf War Illness
|
N/A | |
Completed |
NCT01291758 -
Exercise in Gulf War Illness (GWI)
|
||
Completed |
NCT01011348 -
Q10 for Gulf War Veterans
|
N/A |