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NCT05062083 · ClinicalTrials.gov registry record · Phase 2
PET Imaging of Cyclooxygenase in Multiple Sclerosis
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT05062083: Clinical Trial Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
NCT05062083 is a Phase 2 study that was terminated before completion, run by National Institute of Mental Health (NIMH). The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05062083, a Phase 2 study, was terminated before completion, sponsored by National Institute of Mental Health (NIMH).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. Tracers have been developed for cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), key enzymes that involved in neuroinflammation. Researchers want to explore the role inflammation plays in MS and see if COX-1 and COX-2 are measurable in the brains of people with the disease. Objective: To see if COX-1 and COX-2 are detectable in the brains of individuals with MS. Eligibility: People ages 18 and older with MS who are otherwise healthy. Design: Participants will be screened with their medical history and a physical exam. They will have an EKG to check the electrical activity of the heart. Participants study involvement requires 3 to 5 visits and will last between 2 weeks and 4 months. Participants will have two positron emission tomography (PET) scans of the brain for each tracer. Scans of the same tracer might occur on the same day or on separate days. A small amount of a radioactive chemical will be injected through an intravenous catheter. A needle will be used to guide a thin plastic tube into an arm vein. The needle will be removed. Only the catheter will be left in the vein. The PET scanner is shaped like a doughnut. Participants will lie on a bed that slides in and out of the scanner. They will wear a plastic mask molded to fit the head. The scan will last about 90 minutes for each tracer. Participants will receive the medication ketoprofen or celecoxib orally about 2 hours before the second scan. Participants will have blood tests. Participants must avoid certain medications a month prior to the PET scans.
Primary Outcome
Standard uptake value (SUV) was measured by averaging the SUV of all lesion voxels or tissue contralateral to lesion voxels in the PET image with injection of \[11C\]PS13. The SUVR was calculated by averaging the SUV ratio between lesion or tissue contralateral to lesion voxels and the caudate from 60-90 minutes after the start of the PET scan.
Interventions
- DRUG Celecoxib
- DRUG 11C-MC1
- DRUG 11C-PS13
- DRUG Ketoprofen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2022-06-07 |
| Est. Completion | 2024-01-30 |
| Phase | Phase 2 |
Why NCT05062083 stopped before completion
NCT05062083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 4 interventions - of which Celecoxib is the first listed.
NCT05062083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05062083 about?
NCT05062083 is a clinical study titled "PET Imaging of Cyclooxygenase in Multiple Sclerosis". Background: Multiple sclerosis (MS) is an autoimmune disease that has no cure. MRI is the main tool used in the study and treatment of people with MS. Tracers have been developed for cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2), key enzymes that involved in neuroinflammation. Researchers w...
What is the current status of trial NCT05062083?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2022-06-07. Estimated completion is 2024-01-30.
What interventions are being tested in trial NCT05062083?
The interventions under investigation include: Celecoxib (DRUG), 11C-MC1 (DRUG), 11C-PS13 (DRUG), Ketoprofen (DRUG).
Who is sponsoring clinical trial NCT05062083?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05062083's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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