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NCT04263454 · ClinicalTrials.gov registry record · Phase 2

The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With Fibromyalgia

A Phase 2 study, sponsored by University of Alabama at Birmingham.

Completed
Registry status
Phase 2
Development phase
36
Enrollment target

NCT04263454 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 36 participants.

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The verdict

NCT04263454, a Phase 2 study, has completed, sponsored by University of Alabama at Birmingham.

COMPLETED
Registry status
Phase 2
Development phase
36 participants
Enrollment target

Study Summary

The major goal of this study is to determine if the innate immune response is dysregulated in people with fibromyalgia, compared to healthy controls. Magnetic resonance spectroscopy will be used to measure changes in the brain's metabolic profile following an experimental immune stimulus, to test whether individuals with fibromyalgia show a heightened immune response in the brain. The ultimate goal of this research is to better understand the role of brain inflammation in the pathophysiology of chronic pain and fatigue, which will guide the development of more effective therapies for these conditions.

Interventions

  • PROCEDURE Magnetic Resonance Spectroscopy
  • DRUG Endotoxin, Escherichia Coli

Trial Details

FieldValue
Enrollment Target 36 participants
Start Date 2020-03-11
Est. Completion 2021-12-22
Phase Phase 2

Sponsor

University of Alabama at Birmingham

1,160 total trials

What the Registry Record Tells You About NCT04263454

The ClinicalTrials.gov registry entry for NCT04263454 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Magnetic Resonance Spectroscopy is the first listed.

NCT04263454 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04263454 about?

NCT04263454 is a clinical study titled "The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With Fibromyalgia". The major goal of this study is to determine if the innate immune response is dysregulated in people with fibromyalgia, compared to healthy controls. Magnetic resonance spectroscopy will be used to measure changes in the brain's metabolic profile following an experimental immune stimulus, to test wh...

What is the current status of trial NCT04263454?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2020-03-11. Estimated completion is 2021-12-22.

What interventions are being tested in trial NCT04263454?

The interventions under investigation include: Magnetic Resonance Spectroscopy (PROCEDURE), Endotoxin, Escherichia Coli (DRUG).

Who is sponsoring clinical trial NCT04263454?

This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.