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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: Completed Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT04263454 is a Phase 2 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The concentration of brain metabolite CHO will be measured via MRI scan as a measure of neuroinflammation. This measurement will be performed in both the control and experimental group. Increased CHO is a marker of increased cell turnover that can be seen during neuroinflammation.
Interventions
- PROCEDURE Magnetic Resonance Spectroscopy
- DRUG Endotoxin, Escherichia Coli
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-03-11 |
| Est. Completion | 2021-12-22 |
| Phase | Phase 2 |
What the finished NCT04263454 record still lists
NCT04263454 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Magnetic Resonance Spectroscopy is the first listed.
NCT04263454 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04263454's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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