[C-11]Methylreboxetine Imaging for MS

Recruiting at 1 trial location

Overseen By Tarun Singhal, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Brigham and Women's Hospital

Must not be taking: Tricyclics, SNRIs, NDRIs, Corticosteroids

Disqualifiers: Severe psychiatric, Neurologic disorder, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

19 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for examining brain changes in people with Multiple Sclerosis (MS) using a special imaging technique called PET scans. Researchers aim to determine if PET scans can detect brain injuries more effectively than current methods, particularly in a part of the brain system that may not function properly in MS. The goal is to connect these brain changes with the severity of symptoms, such as fatigue or cognitive issues. Individuals with MS who do not have severe physical disability, as well as healthy individuals willing to undergo brain scans, may be suitable candidates for this study. As a Phase 1, Phase 2 trial, this research seeks to understand how the treatment works in people and to measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

If you are taking tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, or norepinephrine-dopamine reuptake inhibitors, you will need to stop these medications to participate in the trial. Additionally, you cannot have had corticosteroid treatment in the past four weeks.

What prior data suggests that this imaging technique is safe for humans?

Research has shown that [C-11]Methylreboxetine, used in PET scans, is under study for its safety and effectiveness in people with Multiple Sclerosis (MS) and healthy individuals. As this study is in an early phase, the main goal is to assess its safety and tolerability. Early-phase studies typically involve a small number of participants and focus on identifying any side effects.

[C-11]Methylreboxetine has been used in research to study a part of the brain involved in nerve cell communication. This imaging agent helps visualize certain brain activities by attaching to this part. Although specific safety results are not widely available, the study's progression to this phase suggests that early tests have not revealed serious safety concerns.

Prospective participants should discuss any questions or concerns about potential risks and benefits with the research team. They will provide more detailed information about what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Multiple Sclerosis (MS) aim to manage symptoms or slow disease progression by modulating the immune system. However, [C-11]Methylreboxetine presents a unique approach by focusing on molecular imaging of the norepinephrine transporter (NET) using PET scans. This method allows researchers to visualize and understand the role of norepinephrine in MS more precisely. By targeting NET, researchers hope to uncover new insights into the disease's mechanisms, which could lead to innovative therapeutic strategies. This imaging technique is exciting because it could pave the way for personalized treatment options based on a deeper understanding of individual neurochemical changes in MS.

What evidence suggests that this imaging technique is effective for assessing brain injury in Multiple Sclerosis?

Research has shown that a special type of brain scan, [C-11]Methylreboxetine PET imaging, can detect changes in a protein that manages brain chemicals in people with Multiple Sclerosis (MS). This imaging technique is highly precise, accurately identifying this protein in the brain. In this trial, participants with MS will undergo this imaging to assess potential reductions in protein connection, which could indicate damage related to symptoms like fatigue and cognitive issues. Early findings suggest this method might provide a clearer view of brain changes in MS than traditional MRI scans. This could enhance understanding of how MS affects the brain and potentially lead to better treatments. ^{1 2 4 6 7}

Who Is on the Research Team?

Tarun Singhal, M.D.

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for individuals diagnosed with Multiple Sclerosis (MS) who meet specific international criteria, have a disability status score less than 7.5, and are willing to undergo PET and MRI imaging. Participants must also be able to give informed consent.

Inclusion Criteria

I am willing to have PET and MRI scans.

I am between 18 and 70 years old.

Subjects willing and able to give informed consent

Exclusion Criteria

I am not pregnant, nursing, trying to get pregnant, or suspect I might be pregnant.

I am currently taking medication for depression or mood disorders.

Non-MRI compatible implanted devices

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging

Participants undergo PET and MRI scans to assess norepinephrine transporter binding and brain injury

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• [C-11]Methylreboxetine

Trial Overview

[C-11]Methylreboxetine ([C-11]MRB) PET imaging is being tested to see if it can detect brain injury in MS patients by looking at norepinephrine transporter binding. The study compares MS patients with healthy controls and correlates the findings with clinical severity, fatigue, and cognitive impairment.

How Is the Trial Designed?

Group I: Multiple Sclerosis Experimental Treatment 1 Intervention

Subjects meeting the definition for Multiple Sclerosis by the International Panel Criteria, with an Expanded Disability Status Scale (EDSS) less than 6.5.

Group II: Healthy Control Experimental Treatment 1 Intervention

This group will serve as non disease population.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7474089/

Changes of central noradrenaline transporter availability in ...

To assess central NAT availability in vivo, PET was applied using the highly selective radiotracer (S,S)-[11C]O-methylreboxetine ([11C]MRB).

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03207464?cond=multiple+sclerosis&aggFilters=status%3A%2Cphase%3A2

Molecular Imaging of NET Using [C-11]MRB-PET in MS

This study aims to use [C-11]MRB PET (positron emission tomography) imaging to look at brain injury in patients with Multiple Sclerosis (MS) and healthy ...

3.

malacards.org

malacards.org/card/multiple_sclerosis

Multiple Sclerosis (MS)

... [C-11]Methylreboxetine PET in Multiple Sclerosis, Unknown status, NCT03207464 ... Multiple Sclerosis on Self-efficacy, Clinical Outcomes and Cost-effectiveness ...

4.

researchgate.net

researchgate.net/publication/46425957_Evaluation_of_11CMRB_for_assessment_of_occupancy_of_norepinephrine_transporters_Studies_with_atomoxetine_in_non-human_primates

(PDF) Evaluation of [11C]MRB for assessment of ...

We used (S,S)-[¹¹C] methylreboxetine ([¹¹C]MRB) to determine the effective dose 50 (ED₅₀) of methylphenidate for NET. In a within-subject ...

5.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/13524585251370543

ECTRIMS 2025 Late Breaking Poster

Conclusion: High-efficacy DMTs in MS are associated with greater and more sustained sNfL reductions, paralleling superior clinical and MRI ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10687854/

Adverse effects of immunotherapies for multiple sclerosis - PMC

Although it is accepted that immunotherapies for people with MS decrease disease activity, uncertainty regarding their relative safety remains.

7.

pubs.acs.org

pubs.acs.org/doi/10.1021/acschemneuro.2c00589

Exploring the Role of Neurotransmitters in Multiple Sclerosis

In this review, we aim to analyze preclinical and clinical evidence on the alterations in neurotransmitters in MS, and critically discuss their potential role ...