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NCT04144257 · ClinicalTrials.gov registry record · Phase 1
Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue
A Phase 1 study, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
NCT04144257: Completed Phase 1 study, sponsored by Brigham and Women's Hospital.
NCT04144257 is a Phase 1 study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 10 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04144257, a Phase 1 study, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Primary Outcome
PET outcome measure for \[F-18\]PBR06 radioligand used to quantify microglial activation.
Interventions
- DRUG [C-11]Methylreboxetine
- DRUG [F-18]PBR06
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-03-12 |
| Est. Completion | 2021-04-13 |
| Phase | Phase 1 |
What the finished NCT04144257 record still lists
NCT04144257 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which [C-11]Methylreboxetine is the first listed.
NCT04144257 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04144257 about?
NCT04144257 is a clinical study titled "Role of Microglial Activation and Norepinephrine Transporter Abnormalities in Pathogenesis of MS-related Fatigue". 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 ...
What is the current status of trial NCT04144257?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-03-12. Estimated completion is 2021-04-13.
What interventions are being tested in trial NCT04144257?
The interventions under investigation include: [C-11]Methylreboxetine (DRUG), [F-18]PBR06 (DRUG).
Who is sponsoring clinical trial NCT04144257?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04144257's enrollment target sits among peer trials
10 1913th of 2000 higher than 46 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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