Understanding GWI: Integrative Modeling

Status Recruiting

Clinical Trial Summary

The investigator proposes to perform a Phase I study assessing safety, efficacy, and biomarker response to the therapeutic interventions of Etanercept followed by mifepristone for veterans with Gulf War Illness. The investigator will conduct and repeat the exercise challenge before treatment and on therapy to assess the impact of the interventions on homeostatic regulation and the dynamic model identified in prior studies.

Clinical Trial Description

In the Investigator's prior work, the investigator used an exercise stress model (rest, peak oxygen consumption oxygen uptake, and 7 follow-up sampling points) to measure the mediators of relapse in the context of their interactive homeostatic networks. The investigator surveyed the response of genes and blood-borne biomarkers in order to interrogate and map the regulation of neuro-endocrine-autonomic-immune function in these subjects as compared to GW era sedentary healthy controls. This study is the first to test in the GWI human system of the impact of interventions that hope to permanently re-set the key pathway(s) involved in maintaining a "sick" homeostatic network in Gulf War Illness, discovered in our prior CDMRP and VA funded projects. An open-label Phase I study will be performed with Etanercept (once a week for 4 weeks) followed by mifepristone (once a day for 7 days), followed by a 10-week observation to assess safety, efficacy and biomarker response to maximal exercise. The impact of the interventions will be measured on current computational modeling of dynamic response GWI illness mediators at onset, at 6 weeks (on completion of the medication regimen) and 4 months after baseline; using 20 GWI patients. The response during and after an exercise challenge will be assessed followed by map the homeostatic networks in play over the 24 hours post-exercise in subjects before treatment, after completing the second treatment (week 6) and 4 months after initiating treatment (week 16). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04255498
Study type	Interventional
Source	South Florida Veterans Affairs Foundation for Research and Education
Contact	Fanny Collado, RN
Phone	305-575-7000
Email	fanny.collado@va.gov
Status	Recruiting
Phase	Phase 1
Start date	October 30, 2017
Completion date	August 30, 2020

View Details

See also
Status	Clinical Trial	Phase
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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)"
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	`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
Completed	`NCT00810329` - Proteomics of Cerebrospinal Fluid in Chronic Fatigue Syndrome	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.