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NCT04144257

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

Status unknown Phase 1, PHASE2 Last updated 28 July 2021
What this trial tests

Phase 1, PHASE2 trial testing [F-18]PBR06 in Multiple Sclerosis in 12 participants. Status unknown.

Timeline
12 March 2020
Primary endpoint
30 September 2021
30 September 2021

Quick facts

Lead sponsorBrigham and Women's Hospital
PhasePhase 1, PHASE2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment12
Start date12 March 2020
Primary completion30 September 2021
Estimated completion30 September 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 60, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel PET Imaging of Inflammatory Targets and Cells for the Diagnosis and Monitoring of Giant Cell Arteritis and Polymyalgia Rheumatica.
    van der Geest KSM, Sandovici M, Nienhuis PH, Slart RHJA, et al · · 2022 · cited 21× · PMID 35733858 · DOI 10.3389/fmed.2022.902155
  2. Novel Tracers and Radionuclides in PET Imaging.
    Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012

Verify or expand the search:

Other trials of [F-18]PBR06

Trials testing the same drug.

Other recruiting trials for Multiple Sclerosis

Currently open trials in the same condition.

Other Brigham and Women's Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04144257.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing