Trial Outcomes & Findings for The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With Fibromyalgia (NCT NCT04263454)
NCT ID: NCT04263454
Last Updated: 2023-04-14
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
36 participants
Primary outcome timeframe
3 hours (From Baseline to 3 Hrs Post-endotoxin Administration)
Results posted on
2023-04-14
Participant Flow
Participant milestones
| Measure |
Healthy Control
Healthy controls must report no other medical conditions (including fibromyalgia) to be considered for inclusion. All healthy controls will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
Fibromyalgia
Fibromyalgia participants will need to meet 2010 American College of Rheumatology diagnostic criteria for fibromyalgia. All fibromyalgia participants will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
20
|
|
Overall Study
COMPLETED
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
3
|
8
|
Reasons for withdrawal
| Measure |
Healthy Control
Healthy controls must report no other medical conditions (including fibromyalgia) to be considered for inclusion. All healthy controls will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
Fibromyalgia
Fibromyalgia participants will need to meet 2010 American College of Rheumatology diagnostic criteria for fibromyalgia. All fibromyalgia participants will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
|
Overall Study
Physician Decision
|
3
|
5
|
|
Overall Study
Poor Data Quality
|
0
|
1
|
Baseline Characteristics
The Innate Central Nervous System Immune Response to an Experimental Immune Challenge in People With Fibromyalgia
Baseline characteristics by cohort
| Measure |
Healthy Control
n=13 Participants
Healthy controls must report no other medical conditions (including fibromyalgia) to be considered for inclusion. All healthy controls will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
Fibromyalgia
n=12 Participants
Fibromyalgia participants will need to meet 2010 American College of Rheumatology diagnostic criteria for fibromyalgia. All fibromyalgia participants will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
42.6 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
41.3 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Pain Severity
|
0.15 units on a scale
STANDARD_DEVIATION 0.38 • n=5 Participants
|
6.25 units on a scale
STANDARD_DEVIATION 0.45 • n=7 Participants
|
3.2 units on a scale
STANDARD_DEVIATION .41 • n=5 Participants
|
|
Fatigue Severity
|
1.00 units on a scale
STANDARD_DEVIATION 1.23 • n=5 Participants
|
7.17 units on a scale
STANDARD_DEVIATION 1.59 • n=7 Participants
|
4.09 units on a scale
STANDARD_DEVIATION 1.41 • n=5 Participants
|
PRIMARY outcome
Timeframe: 3 hours (From Baseline to 3 Hrs Post-endotoxin Administration)Population: as defined in participant flow
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.
Outcome measures
| Measure |
Fibromyalgia
n=12 Participants
All fibromyalgia participants will undergo the same screening and experimental procedures. However, fibromyalgia participants will need to meet 2010 American College of Rheumatology diagnostic criteria for fibromyalgia. All fibromyalgia participants will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
Healthy Control
n=13 Participants
Healthy controls must report no other medical conditions (including fibromyalgia) to be considered for inclusion. All healthy controls will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
|---|---|---|
|
Change in Ratio of Choline/ Creatine (CHO/CR) in the Brain From Baseline to 3 Hrs Post-endotoxin Administration
|
-.0058 ratio
Standard Deviation .01465
|
-.0021 ratio
Standard Deviation .01664
|
PRIMARY outcome
Timeframe: 3 hours (From Baseline to 3 Hrs Post-endotoxin Administration)Population: as defined in participant flow
The concentration of brain metabolite MI will be assessed via MRI scan as a measure of neuroinflammation. This measurement will be performed in both the control and experimental group. MI is a marker of microglia, and an acute increase in this metabolite could indicate microglia proliferation or accumulation.
Outcome measures
| Measure |
Fibromyalgia
n=12 Participants
All fibromyalgia participants will undergo the same screening and experimental procedures. However, fibromyalgia participants will need to meet 2010 American College of Rheumatology diagnostic criteria for fibromyalgia. All fibromyalgia participants will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
Healthy Control
n=13 Participants
Healthy controls must report no other medical conditions (including fibromyalgia) to be considered for inclusion. All healthy controls will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
|---|---|---|
|
Change in Ratio of Myoinositol/ Creatine (MI/CR) in the Brain From Baseline to 3hrs Post-endotoxin Administration
|
.1030 ratio
Standard Deviation .18022
|
-.0049 ratio
Standard Deviation .31164
|
PRIMARY outcome
Timeframe: 3 hours (From Baseline to 3 Hrs Post-endotoxin Administration)The temperature of the brain will be assessed via MRI scan as a measure of neuroinflammation. This measurement will be performed in both the control and experimental group. Increased brain temperature certain areas may indicate an abnormally increased inflammatory response.
Outcome measures
| Measure |
Fibromyalgia
n=12 Participants
All fibromyalgia participants will undergo the same screening and experimental procedures. However, fibromyalgia participants will need to meet 2010 American College of Rheumatology diagnostic criteria for fibromyalgia. All fibromyalgia participants will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
Healthy Control
n=13 Participants
Healthy controls must report no other medical conditions (including fibromyalgia) to be considered for inclusion. All healthy controls will have an MRI scan performed both before and 3 hours post 0.4ng/kg endotoxin injection.
Endotoxin, Escherichia Coli: Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
Magnetic Resonance Spectroscopy: MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
|
|---|---|---|
|
Change in Brain Temperature From Baseline to 3 Hours Post-endotoxin Administration.
|
0.55 degrees Celsius
Standard Deviation 0.55
|
0.10 degrees Celsius
Standard Deviation 0.44
|
Adverse Events
Healthy Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fibromyalgia
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place