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NCT04144257
Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue
Phase 1, PHASE2 trial testing [F-18]PBR06 in Multiple Sclerosis in 12 participants. Status unknown.
30 September 2021
Quick facts
| Lead sponsor | Brigham and Women's Hospital |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 12 |
| Start date | 12 March 2020 |
| Primary completion | 30 September 2021 |
| Estimated completion | 30 September 2021 |
| Sites | 1 location across United States |
Drugs / interventions tested
- [F-18]PBR06 — full drug profile →
- [C-11]Methylreboxetine — full drug profile →
Conditions studied
- Multiple Sclerosis — all drugs for Multiple Sclerosis →
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):
-
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 -
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:
- PubMed search for NCT04144257
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04144257 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Brigham and Women's Hospital
- Last refreshed: 28 July 2021
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