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New pill could loosen MS muscle stiffness

NCT ID NCT06782490

Symptom relief Sponsor: Celgene Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study tests an experimental oral drug, BMS-986368, for treating muscle stiffness (spasticity) in people with multiple sclerosis. About 200 participants will receive one of three doses of the drug or a placebo. The goal is to see if the drug safely reduces muscle tightness and improves walking and quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BMS-986368 (a FAAH/MAGL inhibitor)
What this could lead to
If successful, this could provide a new oral option to reduce muscle stiffness and spasms in people with multiple sclerosis, improving daily comfort and movement.
What could go wrong
This is an early Phase 2 trial with only 200 participants, so results may not apply to everyone. The drug may cause side effects or prove no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Participants must have a multiple sclerosis (MS) diagnosis. * Participants must have a history of spasticity due to MS for at least 6 months prior to Visit 1. * Participants must have a Modified Ashworth Scale (mAS) score ≥2 in each of 2 muscle groups (at least one muscle group in the leg, excluding ankle plantar flexors) at Visit 1. * Participants must have an Expanded Disability Status Scale (EDSS) score 3.0-6.5 at Visit 1. Exclusion Criteria * Participants must not have any concomitant disease or disorder that has symptoms of spasticity or that may influence the participant's level of spasticity. * Participants must not have an acute MS exacerbation/relapse requiring treatment or alteration in disease modifying drug dose within 3 months of Visit 1 or Visit 2. * Participants must not have a history of any substance abuse disorder as defined in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Diagnostic Criteria for Drug and Alcohol Abuse. * Participants must not be currently taking a medication for spasticity that cannot be discontinued and washed out by Visit 2. * Participants must not have used FAAH/MAGL inhibitor medication or any cannabinoid-related products (including cannabis, cannabidiol (CBD), or tetrahydrocannabinol (THC)) within 30 days prior to Visit 1. * Other protocol-defined Inclusion/Exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis Muscle Spasticity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis spasticity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    48 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alabama Neurology Associates

    RECRUITING

    Birmingham, Alabama, 35209, United States

  • Aqualane Clinical Research

    RECRUITING

    Naples, Florida, 34105, United States

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Box Hill Hospital

    RECRUITING

    Box Hill, Victoria, 3128, Australia

  • Centre de Recherche Saint-Louis

    RECRUITING

    Lévis, Quebec, G6W0M5, Canada

  • Centre for Neuroscience Innovation

    RECRUITING

    Kent Town, South Australia, 5067, Australia

  • Centrum Medyczne NEUROMED

    RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-163, Poland

  • Centrum Medyczne NeuroProtect

    RECRUITING

    Warsaw, Masovian Voivodeship, 01-684, Poland

  • EvergreenHealth Medical Center

    RECRUITING

    Kirkland, Washington, 98034, United States

  • Fakultni Nemocnice u sv. Anny v Brne

    RECRUITING

    Brno, Brno-město, 656 91, Czechia

  • Fakultni Thomayerova nemocnice

    RECRUITING

    Prague, Praha 4, 14059, Czechia

  • Fakultni nemocnice Hradec Kralove

    RECRUITING

    Hradec Králové, Hradec Králové, 500 05, Czechia

  • Hope Neurology

    RECRUITING

    Knoxville, Tennessee, 37922, United States

  • Instytut Zdrowia Dr Boczarska Jedynak

    RECRUITING

    Oświęcim, Lesser Poland Voivodeship, 32-600, Poland

  • John Hunter Hospital

    RECRUITING

    Newcastle, New South Wales, 2305, Australia

  • Klinikum Würzburg Mitte

    RECRUITING

    Würzburg, Bavaria, 97074, Germany

  • Local Institution - 0011

    WITHDRAWN

    Prague, Praha 5, 150 06, Czechia

  • Local Institution - 0017

    WITHDRAWN

    Aurora, Colorado, 80045, United States

  • Local Institution - 0020

    WITHDRAWN

    Essen, 45122, Germany

  • Local Institution - 0031

    WITHDRAWN

    Meisenheim, Rhineland-Palatinate, 55590, Germany

  • Local Institution - 0044

    NOT_YET_RECRUITING

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

  • Local Institution - 0051

    WITHDRAWN

    Słomniki, 32-090, Poland

  • Local Institution - 0061

    WITHDRAWN

    Gdansk, 80-952, Poland

  • Local Institution - 0069

    WITHDRAWN

    Columbus, Ohio, 43235, United States

  • Local Institution - 0072

    NOT_YET_RECRUITING

    Lewisville, Texas, 75067, United States

  • M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM

    RECRUITING

    Katowice, 40-571, Poland

  • Montreal Neurological Institute and Hospital

    RECRUITING

    Montreal, Quebec, H3A2B4, Canada

  • Nemocnice Pardubického kraje

    RECRUITING

    Pardubice, 532 03, Czechia

  • Nemocnice Teplice

    RECRUITING

    Teplice, Ústí nad Labem Region, 415 01, Czechia

  • Neurologischen Gemeinschaftspraxis Kassel und Vellmar

    RECRUITING

    Kassel, Hesse, 34121, Germany

  • Neurology Center of New England

    RECRUITING

    Foxborough, Massachusetts, 02035, United States

  • Neurozentrum Bielefeld

    RECRUITING

    Bielefeld, 33647, Germany

  • Northwest Neurology

    RECRUITING

    Southfield, Michigan, 48034, United States

  • Perron Institute

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Perseverance Research Center,LLC

    RECRUITING

    Scottsdale, Arizona, 85253, United States

  • Pratia MCM Krakow

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-727, Poland

  • Puerto Rico Multiple Sclerosis Center

    RECRUITING

    Caguas, 00725, Puerto Rico

  • Riverside Methodist Hospital

    RECRUITING

    Columbus, Ohio, 43214, United States

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-503, Poland

  • St. Josef und St. Elisabeth Hospital gGmbH

    RECRUITING

    Bochum, North Rhine-Westphalia, 44791, Germany

  • The Ottawa Hospital - General Campus

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal Melbourne Hospital

    RECRUITING

    Parkville, Victoria, 3050, Australia

  • Thomas Jefferson University, Jefferson Headache Center

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • USF Health

    RECRUITING

    Tampa, Florida, 33612, United States

  • Unity Health Toronto, St. Michael's Hospital

    RECRUITING

    Toronto, Ontario, M5B 1W8, Canada

  • Universitaetsklinikum Carl Gustav Carus Dresden

    RECRUITING

    Dresden, 01307, Germany

  • University Hospital - London Health Sciences Centre

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • University Of Alberta Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2G3, Canada

  • University of Cincinnati Medical Center

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Sydney - Brain and Mind Research Institute (BMRI)

    RECRUITING

    Sydney, New South Wales, 2050, Australia

  • Universitätsklinikum Jena

    RECRUITING

    Jena, Thuringia, 07747, Germany

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    RECRUITING

    Münster, North Rhine-Westphalia, 48149, Germany

  • Vseobecna fakultni nemocnice v Praze

    RECRUITING

    Prague, Praha 2, 12111, Czechia

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States