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

NCT04263454 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-04-14

Study results available
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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.

Conditions

  • Fibromyalgia

Interventions

DRUG

Endotoxin, Escherichia Coli

Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.

PROCEDURE

Magnetic Resonance Spectroscopy

MRI is a non-invasive imaging technique and does not utilize ionizing radiation.

Sponsors & Collaborators

  • American Fibromyalgia Syndrome Association

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Jarred M Younger, PhD · University of Alabama at Birmingham

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-03-11
Primary Completion
2021-12-22
Completion
2021-12-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04263454 on ClinicalTrials.gov