Understanding GWI: Integrative Modeling

NCT04255498 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: 4987.84
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Anti-neuroinflammatory; Homeostatic regulation; HPA axis regulator

Outcome Measures

Primary Outcomes (1)

• Biomarker response to therapy using Cytokine panel

  Goal is decreased inflammation

  Change from Baseline at 6 weeks and 16 weeks

Secondary Outcomes (1)

• Biomarker response too therapy using VO2 exercise test

  Change from Baseline at 6 weeks and 16 weeks]

Study Arms (2)

Etanercept

EXPERIMENTAL

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

Drug: Etanercept

Mifepristone

EXPERIMENTAL

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

Drug: Mifepristone

Interventions

Etanercept DRUG

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.

Also known as: Enbrel

Etanercept

Mifepristone DRUG

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.

Also known as: Mifeprex

Mifepristone

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• South Florida Veterans Affairs Foundation for Research and Education: lead
• Nova Southeastern University: collaborator
• United States Department of Defense: collaborator

Study Sites (1)

Miami VA Healthcare System

Miami, Florida, 33125, United States

RECRUITING

MeSH Terms

Conditions

Persian Gulf Syndrome; Occupational Diseases

Interventions

Etanercept; Mifepristone

Condition Hierarchy (Ancestors)

War-Related Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Nancy Klimas, MD

  South Florida Veterans Affairs Foundation for Research and Education

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fanny Collado, RN

CONTACT

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

Amanpreet Cheema, PhD

CONTACT

954-262-2871; acheema@nova.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Environmental Medicine Research and Clinical Program

Model Details: 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.

Study Record Dates

• First Submitted: August 24, 2018
• First Posted: February 5, 2020
• Study Start: October 30, 2017
• Primary Completion: August 15, 2019
• Study Completion: August 30, 2020
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

US (1)