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Etanercept + Mifepristone for Gulf War Syndrome (E/M Trial)
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.
E/M Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowE/M Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 4 trial • 491 Patients • NCT01578850E/M Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Mifepristone 300 mg
- Group 2: Mifepristone 600 mg
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
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."
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."
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."
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."
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."
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)."
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."
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