Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue

StatusCompleted
PhasePhase 1/2
Started

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Record History

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  1. Results posted: Oct 15, 2026 Show 5 more changesShow less
    • Lead sponsor: Brigham and Women's Hospital to Brigham and Women's Hospital
    • Enrollment target: 10 to 14
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints revised (2)
    • Study description revised
  2. Primary endpoints: 1 to 2v3 Show 5 more changesShow less
    • Trial status: Recruiting to Completed
    • Enrollment target: estimated 12 to confirmed 10
    • Primary and study completion dates changed from estimate of Sep 30, 2021 to Apr 13, 2021
    • Secondary endpoints: 5 to 2
    • Study site revised
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 5 more changesShow less
    • Primary and study completion dates: Sep 30, 2020 to Sep 30, 2021
    • Start date changed from estimate of Oct 2019 to Mar 12, 2020
    • Eligibility criteria expanded, about 19 words
    • Site details revised
    • Collaborator revised
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
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.
Trial Details
NCT Number NCT04144257
Lead Sponsor Brigham and Women's Hospital
Collaborators: U.S. Army Medical Research Acquisition Activity
Conditions
(from sponsor)		 Multiple Sclerosis
Related terms Multiple Sclerosis
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov