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NCT04712071 · ClinicalTrials.gov registry record · Early Phase 1
Ketamine in Veterans With Gulf War Illness
A Early Phase 1 study, sponsored by Baylor College of Medicine.
- Terminated
- Registry status
- Early Phase 1
- Development phase
- 1
- Enrollment target
NCT04712071 is a Early Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 1 participants.
The verdict
NCT04712071, a Early Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.
- TERMINATED
- Registry status
- Early Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Up to one third of the 700,000 U.S. military veterans of the 1990-91 Gulf War have Gulf War Illness (GWI), a symptom complex characterized by a combination of chronic pain, cognitive impairment, debilitating fatigue, gastrointestinal complications, and other persistent symptoms. Epidemiologic studies of 1990-1991 Gulf War veterans have identified the short but intense combined exposure to insecticides (e.g., organophosphates, DEET, permethrin), pills with anti-nerve gas agent pyridostigmine bromide (PB), and low-level chemical nerve agents as likely candidates of GWI. Animal models have shown that these neurotoxicants could induce neuroinflammation which is marked by enhanced inflammatory cytokines, and activated microglia and astrocytes. Inflammation has been linked to GWI. Secondary effects of neuroinflammation and glia activation could be excessive glutamate-mediated neuronal activation. There is currently no treatment for symptoms of GWI. Ketamine is an N-methyl-D-aspartate receptor (NMDAR) antagonist. Besides blocking activation of NMDARs, a sub-anesthetic dose (0.5 mg/kg over 40 minutes) of ketamine could be an anti-inflammatory agent, and could protect microglia and astrocytes from being activated by inflammatory agents. This low dose of ketamine has also been shown to improve fatigue within 24 hours after a single infusion, and to improve inflammatory pain. This makes ketamine a feasible candidate for the treatment of inflammation-associated symptoms of GWI. This pilot study will examine if GWI is related to NMDAR functioning, testing effects of a single 40-minute intravenous infusion of 0.5 mg/kg of ketamine on GWI symptom severity in 21 veterans of the 1990-1991 Gulf War who meet Kansas case definition criteria of GWI.
Interventions
- DRUG Ketamine Hydrochloride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2021-02-01 |
| Est. Completion | 2022-02-16 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04712071
The ClinicalTrials.gov registry entry for NCT04712071 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ketamine Hydrochloride is the first listed.
NCT04712071 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04712071 about?
NCT04712071 is a clinical study titled "Ketamine in Veterans With Gulf War Illness". Up to one third of the 700,000 U.S. military veterans of the 1990-91 Gulf War have Gulf War Illness (GWI), a symptom complex characterized by a combination of chronic pain, cognitive impairment, debilitating fatigue, gastrointestinal complications, and other persistent symptoms. Epidemiologic studie...
What is the current status of trial NCT04712071?
This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 1 participants. The study started on 2021-02-01. Estimated completion is 2022-02-16.
What interventions are being tested in trial NCT04712071?
The interventions under investigation include: Ketamine Hydrochloride (DRUG).
Who is sponsoring clinical trial NCT04712071?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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