Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue
What it found
Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.
What was tested
Treatment tested
- [F-18]PBR06
- [C-11]Methylreboxetine
Results by group
Standardized Uptake Value Ratio (SUVR)
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Subjects Diagnosed With Multiple Sclerosis | 0.78 SUVR | 0.06 (Standard Deviation) | 7 |
Area Under the Curve Ratio (AUCR)
Baseline
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Subjects Diagnosed With Multiple Sclerosis | 1.01 AUCR | 0.05 (Standard Deviation) | 7 |
| Subjects Diagnosed With Multiple Sclerosis | 0.84 AUCR | 0.09 (Standard Deviation) | 7 |
Subjects Diagnosed With Multiple Sclerosis
Subjects Diagnosed With Multiple Sclerosis
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Subjects Diagnosed With Multiple Sclerosis | 10 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Standardized Uptake Value Ratio (SUVR)
Baseline
Smouldering inflammationArea Under the Curve Ratio (AUCR)
Baseline
Other measures (2)
Correlations Between Modified Fatigue Impact Scale (MFIS) and PET Outcome Measures
Baseline
FatigueCorrelations Between Expanded Disability Status Scale (EDSS) and PET Outcome Measures
Baseline
Disability progression
Who could take part
Relapsing and progressive · 18 to 60
Inclusion Criteria: * Subjects meeting the definition for RRMS or SPMS by International Panel (2017 McDonald) Criteria. * We will recruit patients with RRMS, recently diagnosed in the last 2 years. There will be no disease modifying therapy restrictions for RRMS or SPMS patients. * Male and female subjects age 18 to 60 years. * Patients able to withhold medication that may interfere with C-11[MRB] radiotracer uptake for 24 hours before the scan. Exclusion Criteria: * Relapse/Corticosteroid treatment in the past 4 weeks to avoid transient effects on imaging * Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse. * Individuals with bipolar disease and schizophrenia * Concurrent medical conditions that contraindicate study procedures. * Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment. * Claustrophobia * Non-MRI compatible implanted devices * Low affinity binders
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The overarching aim is to assess the role of microglial activation and norepinephrine transporter binding in pathogenesis of MS-related fatigue, using novel Positron Emission Tomography (PET) radiotracers, [F-18]PBR06 and [C-11]MRB. Specific Aims: Specific Aim 1: To determine the relationship of cerebral microglial activation, as assessed by [F-18]PBR06 PET, with MS-related fatigue. Specific Aim 2: To determine the relationship of norepinephrine transporter (NET) binding, as assessed by [C-11]MRB PET, with MS-related fatigue. Specific Aim 3: To determine the relationship of microglial activation and NET binding, with grey matter pathology (lesion load and brain atrophy) assessed using 7T MRI, and evaluate their independent contribution in development of MS-related fatigue.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2020
Main results due
Apr 2021
Finished
Apr 2021
Results posted
Oct 2026
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