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COX-2 PET Imaging for Multiple Sclerosis

Phase 2
Waitlist Available
Led By Robert B Innis, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 18 years and older
Able to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is exploring if cyclooxygenase-2 (COX-2), an enzyme found in the brain during inflammation, is detectable in the brains of people with MS.

Who is the study for?
Adults aged 18+ with Multiple Sclerosis (MS) who are in good health can join this trial. They must be using contraception if of childbearing potential, able to consent, and not have other major diseases or unstable conditions. Pregnant or lactating women, those recently exposed to significant radiation, and individuals taking certain medications like NSAIDs or immunosuppressants within a specific timeframe before the PET scans cannot participate.Check my eligibility
What is being tested?
The trial is testing two PET scan tracers, 11C-PS13 and 11C-MCI, to detect COX-2 enzyme activity in the brain as an indicator of inflammation in MS patients. Participants will undergo two PET scans with one involving pre-medication with celecoxib. The study spans from a week up to four months including several visits for screening and blood tests.See study design
What are the potential side effects?
Potential side effects may include reactions related to the radioactive tracer used during PET scans such as discomfort at injection site or allergic reaction. Celecoxib could cause digestive issues, cardiovascular risks like heart attack or stroke especially if participants have existing heart disease risk factors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measure the concentration of radioligands

Trial Design

1Treatment groups
Experimental Treatment
Group I: One armExperimental Treatment2 Interventions
All particpants will receive the same tests
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
11C-PS13
2022
Completed Phase 2
~10
11C-MCI
2022
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,774 Previous Clinical Trials
2,674,297 Total Patients Enrolled
University of MarylandOTHER
160 Previous Clinical Trials
302,277 Total Patients Enrolled
2 Trials studying Multiple Sclerosis
324 Patients Enrolled for Multiple Sclerosis
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,298 Total Patients Enrolled

Media Library

One arm Clinical Trial Eligibility Overview. Trial Name: NCT05062083 — Phase 2
Multiple Sclerosis Research Study Groups: One arm
Multiple Sclerosis Clinical Trial 2023: One arm Highlights & Side Effects. Trial Name: NCT05062083 — Phase 2
One arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05062083 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for me to join this medical trial?

"This clinical trial is recruiting 16 participants with multiple sclerosis aged 18-99. The key requirements are as follows: applicants must have been enrolled in UMB protocol HP-00079860, be of either gender, and demonstrate good health via physical examination and medical history. Additionally, female candidates should employ medically acceptable contraception methods."

Answered by AI

Does this research program accept participants aged below 75 years old?

"This study is enlisting adults aged between 18 and 99."

Answered by AI

Is the research team currently recruiting participants for this experiment?

"Clinicaltrials.gov reports that this clinical trial is currently looking for participants, with the first posting taking place on June 7th 2022 and an update made as recently as September 21st 2022."

Answered by AI

To what extent is this treatment hazardous to individuals?

"Due to the experimental nature of this treatment, and its status as a Phase 2 trial with some data supporting safety but none affirming efficacy, our team at Power gave it an assessment score of 2."

Answered by AI

What is the maximum capacity for enrollment into this experiment?

"Affirmative. Online records on clinicaltrials.gov suggest that this medical trial is still actively recruiting participants, having been initially posted on June 7th 2022 and most recently edited a month ago on September 21st 2022. The study demands 16 volunteers to be found at one location."

Answered by AI
~2 spots leftby Mar 2025