Recruiting
Phase 1

Etanercept & Mifepristone

Sponsor:

South Florida Veterans Affairs Foundation for Research and Education

Code:

NCT04255498

Conditions

Gulf War Illness

Persian Gulf Syndrome

Occupational Diseases

Eligibility Criteria

Sex: Male

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

Etanercept

Mifepristone

Study Details

Brief 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.

Conditions

Gulf War Illness

Persian Gulf Syndrome

Occupational Diseases

Study ID

NCT04255498

Start date

Oct 30, 2017

Status verified date

Jan, 2020

Completion date

Aug 30, 2020

Anticipated

Primary completion date

Aug 15, 2019

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Major depression with psychotic or melancholic features
  • Schizophrenia
  • Bipolar disorder
  • Delusional disorders
  • Dementias of any type
  • History or current alcohol abuse
  • 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Etanercept

50 MG/ML Prefilled Syringe (once a week for 4 weeks)

experimental: Mifepristone

(300 mg once a day for 7 days) will follow the etanercept.

Interventions

Etanercept

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.

Mifepristone

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.

Primary outcome measure

  • Biomarker response to therapy using Cytokine panel [ Time Frame: Change from Baseline at 6 weeks and 16 weeks ]

Central Contacts and Locations

Central contacts

Fanny Collado, RN

305-575-7000fanny.collado@va.gov

Amanpreet Cheema, PhD

954-262-2871acheema@nova.edu

Locations

Miami VA Healthcare System

Recruiting

Miami, Florida, United States, 33125

Contacts

Fanny Collado, RN

305-575-7000fanny.collado@va.gov

Amanpreet Cheema, PhD

954-262-2871acheema@nova.edu

Principal Investigator:

Nancy Klimas, MD

More Information

Sponsor

South Florida Veterans Affairs Foundation for Research and Education

Last update posted

Feb 5, 2020

Last verified

Jan, 2020

Keywords

  • Anti-neuroinflammatory
  • Homeostatic regulation
  • HPA axis regulator

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by South Florida Veterans Affairs Foundation for Research and Education on 2020-02-05.