CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 36 enrolled
Drug / intervention
Endotoxin, Escherichia Coli +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04263454
NCT04263454Phase 3Completed

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

University of Alabama at Birmingham·interventional·Posted Feb 10, 2020·Updated Apr 14, 2023

In Brief

A Phase 3 clinical trial evaluating Endotoxin, Escherichia Coli and Magnetic Resonance Spectroscopy for Fibromyalgia. Completed, enrolled 36 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFibromyalgia
CountriesUnited States

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedFeb 10, 2020
Enrollment StartMar 11, 2020
Primary CompletionDec 22, 2021
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.4 years ago

Interventions

Endotoxin, Escherichia Colidrug

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

Magnetic Resonance Spectroscopyprocedure

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