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Monoclonal Antibodies
Etanercept + Mifepristone for Gulf War Syndrome (E/M Trial)
Phase 1
Recruiting
Led By Nancy Klimas, MD
Research Sponsored by Nova Southeastern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
45-70 years old
Male sex
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 24 weeks
Awards & highlights
E/M Trial 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.
Who is the study for?
This trial is for male individuals aged 45-70 with Gulf War Illness, who were in good health before 1990 and meet specific illness criteria. They must not have severe comorbid conditions or a history of heavy alcohol/tobacco use. Participants should not have certain chronic infections, organ failure, or be on excluded medications like immunosuppressants.Check my eligibility
What is being tested?
The study tests the safety and efficacy of Etanercept followed by Mifepristone to treat symptoms of Gulf War Illness. It's an early-phase trial comparing results with a previous study to find the best dosage and duration for future research.See study design
What are the potential side effects?
Potential side effects may include allergic reactions to the drugs, increased risk of bleeding (especially if on blood thinners), hormonal changes due to Mifepristone, immune system alterations from Etanercept, and other drug-specific adverse effects.
E/M Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 45 and 70 years old.
Select...
I am male.
E/M Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mechanistic effects on biomarker relationships
Safety - incidence and severity of adverse events
Secondary outcome measures
Homeostatic network correction
Side effects data
From 2015 Phase 4 trial • 491 Patients • NCT015788505%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open-Label Treatment
Etanercept
Placebo
E/M Trial Design
2Treatment groups
Experimental Treatment
Group I: Mifepristone 600 mgExperimental Treatment2 Interventions
All participants will receive etanercept 50 mg weekly for 12 weeks. After completion of the etanercept course, participants will be randomized between two Arms of mifepristone. Participants randomized to Arm 2 will receive one week of mifepristone at 600 mg (2x300 mg) daily.
Group II: Mifepristone 300 mgExperimental Treatment2 Interventions
All participants will receive etanercept 50 mg weekly for 12 weeks. After completion of the etanercept course, participants will be randomized between two Arms of mifepristone. Participants randomized to Arm 1 will receive one week of mifepristone at 300 mg daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Etanercept
2005
Completed Phase 4
~4740
Mifepristone
2013
Completed Phase 4
~3080
Find a Location
Who is running the clinical trial?
Nova Southeastern UniversityLead Sponsor
89 Previous Clinical Trials
11,621 Total Patients Enrolled
2 Trials studying Gulf War Syndrome
330 Patients Enrolled for Gulf War Syndrome
RTI InternationalOTHER
188 Previous Clinical Trials
875,944 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
170 Patients Enrolled for Gulf War Syndrome
Miami VA Healthcare SystemFED
17 Previous Clinical Trials
2,381 Total Patients Enrolled
1 Trials studying Gulf War Syndrome
170 Patients Enrolled for Gulf War Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 45 and 70 years old.I was in good health before 1990 according to my medical records.My PTSD, depression, or brain injury is stable and hasn't needed hospital care in the last 5 years.I have a diagnosed condition like arthritis, lupus, or another inflammatory disorder.My fatigue is not explained by any other diagnosed conditions.I have not used any treatments that are not allowed in this study.I have Cushing's disease or high cortisol levels.I do not have any organ failure.I am on specific blood thinners.I am on blood thinners and understand I'll need closer monitoring for bleeding risks.I have conditions like high blood pressure or diabetes, but they are well-managed.I have received a bone marrow or organ transplant.I am currently receiving dialysis.I feel very tired after exercising.You have been diagnosed with severe mental health conditions like major depression with psychotic features, schizophrenia, bipolar disorder, delusional disorders, or any type of dementia. You also have a history of alcoholism or drug abuse.I am not taking any immune-suppressing drugs, except for possibly low-dose or topical steroids.I am taking either Apixaban (except 2.5 mg twice daily) or Warfarin.I am male.I have not treated my sleep disorder like insomnia or breathing issues during sleep.I am not taking medications that could affect my immune system or interfere with exercise tests.I meet the criteria for Gulf War Illness according to modified Kansas and CDC guidelines.I am on Warfarin and will have my dose adjusted for the trial.My liver function is impaired, but I may qualify if I have Gilbert's syndrome with normal tests except for bilirubin.I have a history of or currently have QT prolongation.I am allergic to mifepristone, misoprostol, or related medicines.I have been treated with therapies like growth factors or stem cell therapy.I have kidney problems, with high creatinine or low eGFR, or I'm on dialysis.I am scheduled for surgery within the next 24 weeks.My diabetes is not under control (A1c>7.5).I am not taking any herbal medicine with licorice root.My Apixaban dose has been cut in half.
Research Study Groups:
This trial has the following groups:- Group 1: Mifepristone 300 mg
- Group 2: Mifepristone 600 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Etanercept attained the necessary regulatory accreditations to be marketed?
"Our team's assessment of the safety of Etanercept is a score 1, which reflects that this Phase 1 trial has only provided limited data on both efficacy and safety."
Answered by AI
What are the prerequisites for taking part in this research endeavor?
"This medical trial is searching for 20 individuals between the ages of 45 and 70 who are suffering from gulf war illness. Only these patients will be accepted into this study."
Answered by AI
Are there any available openings for this research endeavor?
"Affirmative. According to the information hosted on clinicaltrials.gov, this research trial is currently recruiting participants starting from 9/24/2021 and up until 5/9/2022. 20 patients are required for this study occurring at one medical facility."
Answered by AI
How many participants are in the current clinical trial?
"Affirmative, the information found on clinicaltrials.gov shows that this research study is actively enrolling patients. The experiment was launched on September 24th 2021 and last modified on May 9th 2022, with a requirement of 20 participants to be recruited from 1 medical facility."
Answered by AI
Are the age restrictions for this research restricted to persons over 65 years of age?
"This research project includes age restrictions, with the minimum being 45 years old and a maximum of 70."
Answered by AI
What conditions are typically managed with the drug Etanercept?
"Etanercept is widely used to treat pyoderma gangrenosum, and also has the potential to reduce hyperglycemia levels as well as moderate-severe signs of psoriasis vulgaris (plaque psoriasis)."
Answered by AI
What other medical experiments have been conducted using Etanercept?
"As of now, 43 Etanercept trials are taking place worldwide, with 12 in their final stage. Of the 692 clinical sites participating in these studies, most are located in New york City."
Answered by AI
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