Summary: This pilot trial examined the utility of the glucocorticoid receptor antagonist mifepristone to resolve dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis. While the primary clinical outcome measure, change in self-reported physical health, was not achieved, the data suggested mifepristone may have cognitive-enhancing effects, such as improved verbal learning.

ClinicalTrials.gov Identifier: NCT00691067

Status (2021): COMPLETED

Summary: This study aimed to determine if naltrexone and dextromethorphan are efficacious in addressing systemic inflammation and relieving symptoms in veterans with Gulf War illness. While there was no statistically significant benefit from the treatments across the overall cohort, a subset of responders saw benefit, particularly with low dose naltrexone (LDN).

ClinicalTrials.gov Identifier: NCT02206490

Status (2021): COMPLETED

Summary: This was a randomized clinical trial of a combination treatment with methylphenidate plus a GWI-specific nutrient formula (KPAX002) to address mitochondrial dysfunction-related health issues. Fifteen (15) subjects met intent-to-treat criteria. Participants had a significant reduction in overall symptom severity as demonstrated by reductions in a health inventory, GWI Symptom Assessment Tool.

ClinicalTrials.gov Identifier: NCT02357030

Status (2021): COMPLETED

Summary: This trial is based on the hypothesis that chronic inflammation is part of the underlying pathophysiology of GWI. Prednisone is evaluated to alleviate inflammation related symptoms of pain, fatigue and cognitive dysfunction and improve quality-of-life.

ClinicalTrials.gov Identifier: NCT02506192

Status (2021): COMPLETED

Summary: This study aims to examine the utility of the FDA-approved antibiotic D-cycloserine to improve memory, attention and mood, and reduce neuroinflammation in ill Gulf War veterans.

ClinicalTrials.gov Identifier: NCT02983734

Status (2021): CLOSED

Summary: This trial aims to inhibit autoantibody production using a B-cell depleting therapy (rituximab) to block harmful autoantibodies and reduce inflammation to address the symptoms of Gulf War illness.

ClinicalTrials.gov Identifier: Pending

Status (2021): Re-opening in 2021

Summary: This pilot trial is 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. Participants will perform an exercise challenge before treatment and on therapy to assess the impact of the interventions on homeostatic regulation and re-boot, and enhance the dynamic model identified in prior studies.

ClinicalTrials.gov Identifier: NCT04255498

Status (2021): Enrollment Complete; analyzing results

Summary: This pilot trial is a Phase I study assessing safety, efficacy, and biomarker response to the therapeutic interventions of Etanercept (longer term than prior study above) followed by mifepristone (two dose levels) for veterans with Gulf War illness. Participants will perform an exercise challenge before treatment and on therapy to assess the impact of the interventions on homeostatic regulation and re-boot, and enhance the dynamic model identified in prior studies.

This is the first study being conducted by the GWIRP FY17 Clinical Consortium (GW170044).

ClinicalTrials.gov Identifier: NCT04254627

Status (2021): OPEN

Summary: A Phase II randomized double-blind, placebo-controlled, futility trial. The primary aim is to test the efficacy of hormone replacement therapy (rhGH) to reduce truncal fat mass as a sensitive biomarker of the biological effect of GHRT in this population.

ClinicalTrials.gov Identifier: Pending

Status (2021): PENDING