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RecruitingPHASE2INTERVENTIONAL

A Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368 in Participants With Multiple Sclerosis Spasticity

This research study is looking into a new treatment called BMS-986368 for people who experience muscle stiffness, known as spasticity, due to multiple sclerosis (MS). Many people with MS find spasticity can make everyday tasks difficult. The main goals of this study are to find out if this new medicine is effective at reducing spasticity, if it's safe to use, and how well people cope with taking it. To compare the new medicine, some participants will receive BMS-986368, and others will receive a placebo (a dummy medicine with no active ingredients). This type of study, called a Phase 2 trial, helps researchers learn more about a new treatment before it can be widely used.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Celgene
Enrolment target
200
Start
05 Jun 2025
Estimated completion
09 Jun 2027

What is this study about?

Living with multiple sclerosis (MS) can present many challenges, and one common issue is muscle stiffness, or spasticity. This stiffness can make movements difficult and impact daily life.

Researchers are always looking for new and better ways to manage MS symptoms. This particular study is evaluating a new medicine, BMS-986368, specifically designed to help with spasticity in people with MS. The aim is to see if this medicine can make a real difference for those affected.

During the study, some participants will receive the new medicine, while others will receive a placebo – a substance that looks exactly like the medicine but contains no active ingredients. This is a standard way for researchers to fairly compare the effects of the new medicine. By doing this, they can be sure any changes observed are truly due to the BMS-986368 and not just other factors.

Key takeaways

  • This study evaluates a new drug (BMS-986368) for MS-related muscle stiffness.
  • It aims to check the safety, effectiveness, and tolerability of the medicine.
  • Some participants will receive the active drug, others a placebo.
  • You must have MS and long-standing spasticity to be considered.
  • Participation involves clinic visits and close monitoring.
  • You can stop participating at any time.

Who may be eligible?

To be considered for this study, you need to have a diagnosis of multiple sclerosis (MS) and have experienced muscle stiffness (spasticity) related to MS for at least six months. Your muscle stiffness needs to be at a certain level in specific muscle groups, including at least one leg muscle group (but not just your ankle muscles).

There are also some reasons why you might not be able to join. For example, if you have other conditions that cause spasticity or if you've recently had an MS flare-up that required treatment. You also shouldn't have a history of substance abuse or be taking certain medications for spasticity that you can't stop before the study. Specifically, you shouldn't have used any cannabis-related products, including CBD or THC, within 30 days before the study starts. Participants must be between 18 and 70 years old.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have a diagnosis of Multiple Sclerosis (MS)?
  2. Have I had MS-related muscle stiffness (spasticity) for at least 6 months?
  3. Is my muscle stiffness present in certain leg muscles (but not just my ankles)?
  4. Am I between 18 and 70 years old?
  5. Have I avoided cannabis-related products (like CBD or THC) for at least 30 days?
  6. Am I not currently taking spasticity medication that I can't stop, or have I not had a recent MS flare-up needing treatment?
Answer every question to see your result.

What does participation involve?

This study involves taking either the new medicine, BMS-986368, or a placebo, which looks identical but has no active ingredients. You would have several visits to the study clinic where various assessments will be done to check how you are doing, including how your spasticity is responding and any side effects you might experience. This will involve physical examinations and other tests. You will be closely monitored by medical staff throughout the study. The total duration of your participation in the study, including all visits and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as contributing to medical knowledge and potentially gaining access to a new treatment before it's widely available. However, there are also potential risks involved, like experiencing side effects from the new medicine or the treatment not working for you. The study team will explain all known risks and closely monitor you for any unexpected effects. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (54)

  • Alabama Neurology Associates
    Verified postcode
    Birmingham, United States· Recruiting
  • Perseverance Research Center,LLC
    Verified postcode
    Scottsdale, United States· Recruiting
  • Local Institution - 0017
    Verified postcode
    Aurora, United States· Withdrawn
  • Aqualane Clinical Research
    Verified postcode
    Naples, United States· Recruiting
  • USF Health
    Verified postcode
    Tampa, United States· Recruiting
  • University of Kansas Medical Center
    Verified postcode
    Kansas City, United States· Recruiting
  • Neurology Center of New England
    Verified postcode
    Foxborough, United States· Recruiting
  • Local Institution - 0071
    Verified postcode
    Southfield, United States· Not yet recruiting
  • Washington University School of Medicine
    Verified postcode
    St Louis, United States· Recruiting
  • University of Cincinnati Medical Center
    Verified postcode
    Cincinnati, United States· Recruiting
  • Riverside Methodist Hospital
    Verified postcode
    Columbus, United States· Recruiting
  • Local Institution - 0069
    Verified postcode
    Columbus, United States· Withdrawn

Common questions

What is spasticity?

Spasticity is a common symptom of MS that causes your muscles to become stiff, tight, or go into spasms. This can make moving difficult and sometimes painful.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the effects of the new medicine fairly.

What does 'Phase 2' mean for a study?

Phase 2 means this is an early stage of testing where researchers are primarily looking to see if the medicine is safe and if it shows promise in treating the condition, as well as finding the right dose.

Will I know if I'm getting the active medicine or the placebo?

Usually, in this type of study, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo. This is to ensure the results are as unbiased as possible.

Can I continue my other MS treatments if I join?

The study has specific rules about what other medicines you can and cannot take. The study team will review all your current medications to determine if you are eligible.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study to Evaluate the Efficacy, Safety and Tolerability of…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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