Recruiting
Phase 1
Phase 2

Molecular Imaging

Sponsor:

Brigham and Women's Hospital

Code:

NCT03207464

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

[C-11]Methylreboxetine

Study Details

Brief summary:

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 individuals. The overarching hypothesis is that there is decreased radioligand binding to the norepinephrine transporter in multiple sclerosis, reflecting injury to the noradrenergic system and that it plays a role in disease pathogenesis, its clinical manifestations and severity. This strategy is targeted to address an unmet need because currently available MRI techniques lack sensitivity and specificity for assessing such changes in the brains of people with MS.

The specific aims of the study are:

1. To determine norepinephrine transporter binding in the brains of MS patients using \[C-11\]MRB PET and compare it with age, and sex matched healthy controls.
2. To determine correlation of norepinephrine transporter binding with clinical severity and MRI parameters in MS.
3. To determine correlation of norepinephrine transporter binding with fatigue and cognitive impairment in MS patients.

Conditions

Multiple Sclerosis

Study ID

NCT03207464

Start date

Oct 10, 2017

Status verified date

Jan, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Individuals meeting the definition for Multiple Sclerosis by the International Panel Criteria, with an Expanded Disability Status Scale (EDSS) less than 7.5
2. Male and female subjects age 18 to 70 years
3. Subjects willing to undergo PET and MRI imaging
4. Subjects willing and able to give informed consent

Exclusion Criteria:

1. Individuals with a comorbid severe psychiatric condition such as schizophrenia, bipolar disorder, or post-traumatic stress disorder.
2. Individuals with a known alternate neurologic disorder, previous head injury, or substance abuse.
3. Individuals taking tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors, or norepinephrine-dopamine reuptake inhibitors.
4. Concurrent medical conditions that contraindicate study procedures.
5. Women who are pregnant or nursing. Also, any woman who is seeking to become pregnant or suspects she is pregnant will be excluded from enrollment.
6. Claustrophobia
7. Non-MRI compatible implanted devices
8. Corticosteroid treatment in the past four weeks

Study Design

Enrollment

19 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Multiple Sclerosis

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

experimental: Healthy Control

This group will serve as non disease population.

Interventions

[C-11]Methylreboxetine

8 individuals with Multiple Sclerosis and 4 healthy controls will undergo a \[C-11\]MRB PET scan and a MRI scan.

Primary outcome measure

  • [C-11]Methylreboxetine area under the curve ratios [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Tarun Singhal, M.D.

617-264-3043tsinghal@bwh.harvard.edu

Locations

Brigham MS Center, 60 Fenwood Road

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Steven Cicero

617-264-3044scicero@bwh.harvard.edu

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2026-02-02.