Etanercept for Gulf War Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Gulf War SyndromeEtanercept - Drug
Eligibility
45 - 70
Male
What conditions do you have?
Select

Study Summary

This trial will test if a combination of two drugs is effective and safe for treating Gulf War Illness, a condition with many symptoms that can be debilitating.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Baseline and 24 weeks

16 weeks
Safety - incidence and severity of adverse events
Baseline and 24 weeks
Homeostatic network correction
Mechanistic effects on biomarker relationships

Trial Safety

Safety Progress

1 of 3

Side Effects for

Open-Label Treatment
5%Upper respiratory tract infection
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT01578850) in the Open-Label Treatment ARM group. Side effects include: Upper respiratory tract infection with 5%.

Trial Design

2 Treatment Groups

Mifepristone 600 mg
1 of 2
Mifepristone 300 mg
1 of 2

Experimental Treatment

20 Total Participants · 2 Treatment Groups

Primary Treatment: Etanercept · No Placebo Group · Phase 1

Mifepristone 600 mgExperimental Group · 2 Interventions: Mifepristone, Etanercept · Intervention Types: Drug, Drug
Mifepristone 300 mgExperimental Group · 2 Interventions: Mifepristone, Etanercept · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mifepristone
FDA approved
Etanercept
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 24 weeks

Who is running the clinical trial?

Nova Southeastern UniversityLead Sponsor
79 Previous Clinical Trials
10,484 Total Patients Enrolled
3 Trials studying Gulf War Syndrome
594 Patients Enrolled for Gulf War Syndrome
RTI InternationalOTHER
157 Previous Clinical Trials
763,469 Total Patients Enrolled
2 Trials studying Gulf War Syndrome
434 Patients Enrolled for Gulf War Syndrome
Miami VA Healthcare SystemFED
16 Previous Clinical Trials
2,251 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
170 Patients Enrolled for Gulf War Syndrome
Nancy Klimas, MDPrincipal InvestigatorMiami VA Healthcare System
3 Previous Clinical Trials
242 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
170 Patients Enrolled for Gulf War Syndrome

Eligibility Criteria

Age 45 - 70 · Male Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
In good health by medical history prior to 1990 via Self-Report.
A vaccination is required for influenza and pneumococcal pneumonia.
You have a score of 50 or higher on the Davidson Trauma scale.
You have 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.
You are able to give informed consent.\n