Gulf War IllnessPhase 1NCT04255498
Understanding GWI: Integrative Modeling
A Phase 1 study testing Etanercept and Mifepristone in people with Gulf War Illness and Persian Gulf Syndrome, run by South Florida Veterans Affairs Foundation for Research and Education at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 years, men only
- Conditions the study is for
- Gulf War Illness, Persian Gulf Syndrome, Occupational Diseases
- What is being tested?
- Etanercept and Mifepristone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 30 Aug 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male Veterans who were deployed in 1990 -1991 Gulf War.
- Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
- Veterans who were in good health based on medical history prior to 1990.
- Veterans who are between 40 to 70 years old
- Veterans who currently do not have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity.
Who cannot join
- Major depression with psychotic or melancholic features
- Schizophrenia
- Bipolar disorder
- Delusional disorders
- Dementias of any type
- History or current alcohol abuse
Show all 18Show fewer
- History or current drug abuse
- Organ failure
- Transplant
- Defined rheumatologic
- Inflammatory disorders
- HIV
- Hepatitis B and C
- Primary sleep disorders
- Steroids
- Immunosuppressives
- Medications that impact immune function such as Enbrel or Methotrexate
- Tuberculosis or past history of tuberculosis exposure, as documented by PPD positivity
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Miami VA Healthcare System
Miami, Florida, 33125
Fanny Collado, RN, 305-575-7000 ext. 6706, fanny.collado@va.gov
Amanpreet Cheema, PhD, 954-262-2871, acheema@nova.edu
About this study
Official title: Understanding Gulf War Illness: An Integrative Modeling Approach
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.
Read the detailed 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).
- Being tested
- Etanercept, Mifepristone
- Keywords
- Anti-neuroinflammatory, Homeostatic regulation, HPA axis regulator
- Medical subject headings
- Persian Gulf Syndrome, Occupational Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EtanerceptDrug
Also called Enbrel
Perform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy.
Perform dynamic modeling studies before and after 5 weeks of therapy, repeating the method used previously, in order to document the response to exercise and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time with blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies.
MifepristoneDrug
Also called Mifeprex
Perform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy.
Perform dynamic modeling studies before and after 5 weeks of therapy, repeating the method used previously, in order to document the response to exercise and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time with blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies.
| Study group | Role | What they receive |
|---|---|---|
| Etanercept | Experimental | 50 MG/ML Prefilled Syringe (once a week for 4 weeks) Receives: Drug: Etanercept |
| Mifepristone | Experimental | (300 mg once a day for 7 days) will follow the etanercept. Receives: Drug: Mifepristone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker response to therapy using Cytokine panel
Goal is decreased inflammation
Measured: Change from Baseline at 6 weeks and 16 weeks
Secondary outcomes (1)
Biomarker response too therapy using VO2 exercise test
Goal is that both will prove safe for use in GWI patients
Measured: Change from Baseline at 6 weeks and 16 weeks]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start30 Oct 2017
- Primary completion15 Aug 2019
- Study completion30 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gulf War IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Perform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and Education
- Sponsor type
- US federal agency
- Collaborators
- Nova Southeastern University, United States Department of Defense
- Responsible party
- Principal investigator, Nancy Klimas, South Florida Veterans Affairs Foundation for Research and Education
- Investigators
- Nancy Klimas, MD, Principal investigator, South Florida Veterans Affairs Foundation for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04255498
- Sponsor's protocol ID
- 4987.84
- Status last verified
- Jan 2020
- First submitted
- 24 Aug 2018
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Gulf War Illness: An Integrative Modeling Approach
- ClinicalTrials.gov ID
- NCT04255498
- Acronym / sponsor ID
- 4987.84
- Keywords
- Anti-neuroinflammatory, Homeostatic regulation, HPA axis regulator
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- South Florida Veterans Affairs Foundation for Research and EducationUS federal agency
- Collaborators
- Nova Southeastern University, United States Department of Defense
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 15 Aug 2019 (actual)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Perform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy.
| Arm | Type | Receives |
|---|---|---|
| Etanercept | Experimental | Drug: Etanercept50 MG/ML Prefilled Syringe (once a week for 4 weeks) |
| Mifepristone | Experimental | Drug: Mifepristone(300 mg once a day for 7 days) will follow the etanercept. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male Veterans who were deployed in 1990 -1991 Gulf War.
- Veterans who currently meet the Kansas Gulf War Study Case Definition for Gulf War Illness.
- Veterans who were in good health based on medical history prior to 1990.
- Veterans who are between 40 to 70 years old
- Veterans who currently do not have exclusionary diagnoses that could reasonably explain the symptoms of their fatiguing illness and their severity.
Key exclusion criteria (18 listed)
- Major depression with psychotic or melancholic features
- Schizophrenia
- Bipolar disorder
- Delusional disorders
- Dementias of any type
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EtanerceptAlso: EnbrelPerform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy. Perform dynamic modeling studies before and after 5 weeks of therapy, repeating the method used previously, in order to document the response to exercise and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time with blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies. | Drug | Etanercept |
| MifepristoneAlso: MifeprexPerform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy. Perform dynamic modeling studies before and after 5 weeks of therapy, repeating the method used previously, in order to document the response to exercise and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time with blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies. | Drug | Mifepristone |
Primary outcome
Biomarker response to therapy using Cytokine panel
Time frame: Change from Baseline at 6 weeks and 16 weeks
Goal is decreased inflammation
1 secondary outcome
Biomarker response too therapy using VO2 exercise test
Time frame: Change from Baseline at 6 weeks and 16 weeks]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Gulf War Illness
RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
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Ca-Mg Butyrate in Gulf War Illness
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Pycnogenol (French Maritime Pine Bark) for the Treatment of Gulf War Illness
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Clinical Evaluation of Montelukast in Veterans With Gulf War Illness
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Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Klimas, MD principal investigator
South Florida Veterans Affairs Foundation for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Etanercept and Mifepristone in people with Gulf War Illness and Persian Gulf Syndrome, run by South Florida Veterans Affairs Foundation for Research and Education at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fanny Collado, RN (305-575-7000 ext. 6706, fanny.collado@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarker response to therapy using Cytokine panel (time frame: Change from Baseline at 6 weeks and 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2020.