Phase 3 N=36 Triple-blind Other

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

Fibromyalgia

Bottom Line

View on ClinicalTrials.gov: NCT04263454 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2023

Primary outcome: Primary: Change in Ratio of Choline/ Creatine (CHO/CR) in the Brain From Baseline to 3 Hrs Post-endotoxin Administration — -.0021; -.0058 ratio

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Endotoxin, Escherichia Coli (Drug); Magnetic Resonance Spectroscopy (Procedure)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of Alabama at Birmingham
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Ratio of Choline/ Creatine (CHO/CR) in the Brain From Baseline to 3 Hrs Post-endotoxin Administration	-.0021; -.0058	—
PRIMARY Change in Ratio of Myoinositol/ Creatine (MI/CR) in the Brain From Baseline to 3hrs Post-endotoxin Administration	-.0049; .1030	—
PRIMARY Change in Brain Temperature From Baseline to 3 Hours Post-endotoxin Administration.	0.10; 0.55	—

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.

Eligibility Criteria

Inclusion Criteria

Female;
Age 18-55, inclusive;
Adequate English for study participation;
(fibromyalgia group only) Meet 2010 American College of Rheumatology criteria for the diagnosis of fibromyalgia
Able to undergo IV cannulation and to provide the requisite blood samples;
BMI 18-39.9 inclusive;
Resting heart rate ≥55
Supine systolic blood pressure of 100mmHg AND
Diastolic blood pressure 60mmHg at screening.

Exclusion Criteria

Cardiovascular, immune or infectious disease (e.g. HIV, HCV), or diabetes;
At screening, a 12-lead ECG demonstrating QTc>450 or QRS >120msec. If the QTc exceeds 450msec, or QRS exceeds 120msec, the ECG will be repeated x2 and the median of the three values will be used to determine the participant's eligibility.
Rheumatologic or autoimmune disease;
Vaccine administered within 4 weeks of study participation;
Viral or bacterial illness requiring medical attention and/or antibiotics within 3 months of study participation, or any illness or fever within 1 month of study participation;
Surgical procedure within 3 months of study participation;
Regular use of anti-inflammatory of immunomodulatory drugs (occasional use of NSAIDs is not an exclusion as long as the participant does not administer within 5 days of study participation);
Current use of opioid medication;
Current smoker or ceased smoking ≤12 months prior to participation;
High alcohol consumption;
Consumption of drugs of abuse (except alcohol);
Significant psychological comorbidity that in the discretion of the investigator compromises study integrity;
Current participation in any other research;
Ongoing litigation or worker's compensation claim;
Hospital Anxiety and Depression score indicating clinically significant depression;
Currently pregnant or positive screening urine pregnancy test;
Complete blood count values outside the normal clinical ranges, erythrocyte sedimentation rate (ESR) >60, C-reactive protein (CRP) >3, positive rheumatoid factor (RHF), or positive antinuclear antibodies (ANA).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04263454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.