What side effects are associated with this type of intervention?

Common treatments for Multiple Sclerosis (MS) include interferon beta-1a, glatiramer acetate, fingolimod, and dimethyl fumarate. Interferon beta-1a can cause flu-like symptoms, injection site reactions, and elevated liver enzymes. Glatiramer acetate may lead to local injection site reactions and, rarely, hepatotoxicity. Fingolimod is associated with headaches, elevated liver enzymes, bradyarrhythmia, macular edema, and increased risk of infections. Dimethyl fumarate commonly causes flushing, gastrointestinal issues, and lymphopenia. These treatments aim to modify the disease course and manage symptoms, but they come with a range of potential side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

FDA-approved treatments for Multiple Sclerosis (MS) include a variety of disease-modifying therapies (DMTs) such as interferon beta-1a, glatiramer acetate, and alemtuzumab. These treatments primarily aim to reduce relapse rates and slow disease progression. While 11C-BMS-986196 is a radiolabeled compound used for imaging central nervous system activity, similar imaging agents are not typically used as treatments but rather as diagnostic tools to monitor disease activity and treatment efficacy. Therefore, the focus remains on DMTs that manage the symptoms and progression of MS.

What other types of research exist?

Promising alternatives to 11C-BMS-986196 for imaging CNS activity in Multiple Sclerosis patients include 18F-MNI-659 and 18F-MNI-654, which are novel PDE10A PET radiotracers. These tracers have shown favorable dosimetry and effective brain imaging capabilities, making them potential candidates for CNS imaging in MS.

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A Study to Evaluate the Safety, Tolerability, Kinetics, Biodistribution and Repeatability of 11C-BMS-986196 After Intravenous (IV) Administration in Healthy Participants and After Repeat IV Administration in Participants With Multiple Sclerosis

Phase 1

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug called 11C-BMS-986196 by injecting it into healthy people and those with multiple sclerosis. Researchers want to see how the drug moves through the body and its effects on the brain and spinal cord.

Who is the study for?

This trial is for adults with a BMI of 18-34 kg/m2 and weight ≥50 kg. Healthy participants are needed, as well as those diagnosed with MS per the McDonald criteria, having an EDSS score of 0-6.5. People can't join if they've had recent surgery or have benign MS, spinal MS without brain lesions, or any significant illness.

What is being tested?

The study tests the safety and body distribution of a substance called 11C-BMS-986196 given through IV to healthy people and those with multiple sclerosis (MS). It looks at how the body processes this substance and its effects on the central nervous system.

What are the potential side effects?

While specific side effects aren't listed here, generally such studies monitor for reactions at injection sites, changes in vital signs like blood pressure or heart rate, allergic reactions, headaches or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B - Participants with MSExperimental Treatment1 Intervention

Group II: Part A - Healthy ParticipantsExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

11C-BMS-986196

2021

Completed Phase 1

~10

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Multiple Sclerosis (MS) treatments primarily aim to modulate the immune system to reduce inflammation and prevent further damage to the central nervous system (CNS). Beta interferons work by reducing the frequency and severity of relapses by modulating immune response. Glatiramer acetate mimics myelin basic protein, acting as a decoy for immune cells. Dimethyl fumarate activates the Nrf2 pathway, providing anti-inflammatory and neuroprotective effects. Natalizumab blocks the migration of immune cells into the CNS by targeting the alpha-4 integrin. Fingolimod traps immune cells in lymph nodes, preventing them from reaching the CNS. These mechanisms are crucial for MS patients as they help manage symptoms, reduce relapses, and slow disease progression. The study of 11C-BMS-986196, a radiolabeled compound for imaging CNS activity, is significant as it may provide insights into the biodistribution and kinetics of these treatments, potentially leading to more targeted and effective therapies.

Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis.