Study of BMS-986368 to treat muscle stiffness in people with Multiple Sclerosis

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What is this study about?

This clinical trial focuses on people with Multiple Sclerosis Spasticity, a condition where muscles become stiff and difficult to control in people who have multiple sclerosis. The study will test a new medication called BMS-986368 (also known as CC-97489), which is taken as oral capsules. The medication works by inhibiting certain proteins in the body called FAAH and MAGL.

The purpose of this study is to evaluate how well different doses of BMS-986368 work compared to placebo in reducing muscle stiffness in people with multiple sclerosis. The study will test three different doses of the medication, and participants will be randomly assigned to receive either the study medication or placebo.

During the study, participants will take the assigned medication orally. The main focus will be on measuring changes in leg muscle stiffness over a 6-week period. The study will also look at how the medication affects daily activities and walking ability. Throughout the study, participants will need to complete questionnaires about their symptoms and undergo various assessments to monitor their condition.

1 Initial assessment

Your eligibility for the study will be evaluated based on specific criteria, including age (18-70 years), confirmed multiple sclerosis (MS) diagnosis, and presence of spasticity (muscle stiffness) for at least 6 months

A physical examination will assess your muscle stiffness using the modified Ashworth Scale (mAS) and your disability level using the Expanded Disability Status Scale (EDSS)

2 Treatment period start

You will be randomly assigned to receive either CC-97489 capsules (1mg or 3mg) or a placebo (capsule without active medication)

The medication will be taken orally according to the prescribed schedule

Neither you nor your doctor will know which treatment you are receiving

3 Daily monitoring

You will receive an electronic diary to rate your spasticity daily using the Numeric Rating Scale-Spasticity (NRS-S)

The study will track changes in your leg muscle stiffness using the Total Numeric-transformed Modified Ashworth Scale

4 Regular assessments

Your walking ability will be measured using the Timed 25-Foot Walk test

You will complete the MS Spasticity Scale (MSSS-88) questionnaire about how spasticity affects your daily activities

Your doctor will evaluate the severity of your condition

5 Study completion

The main evaluation period lasts 6 weeks

Your muscle stiffness will be compared between the start and end of the treatment period

The study is scheduled to run from September 2025 to January 2027

Who Can Join the Study?

You must be between 18 and 70 years old and have been diagnosed with multiple sclerosis (MS)
You must have experienced muscle stiffness (spasticity) related to MS for at least 6 months before the first study visit
You must have significant muscle stiffness in at least two different muscle groups, with at least one being in your leg (not including ankle muscles). This will be measured using a special scale called the modified Ashworth Scale, where your score must be 2 or higher
Your disability level, measured by a scale called the Expanded Disability Status Scale (EDSS), must be between 3.0 and 6.5, which means you have moderate to significant disability but can still walk with or without assistance
Both men and women can participate in this study

Who Cannot Join the Study?

Age under 18 or over 65 years old
Pregnant or breastfeeding women
History of severe allergic reactions to medications
Current participation in other clinical trials
Serious heart, liver, or kidney problems
Uncontrolled high blood pressure (hypertension)
History of drug or alcohol abuse within the past year
Major surgery in the last 3 months
Current treatment with medications that could interact with the study drug
Severe depression or other major psychiatric conditions
Active infections or serious medical conditions that could interfere with the study
Unable to follow study procedures or attend scheduled visits
History of cancer in the past 5 years (except treated skin cancer)
Significant changes in MS medications in the past 3 months
Immunosuppression (weakened immune system) due to disease or medications

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country
Technische Universitaet Dresden	Dresden	Germany
Nemocnice Pardubickeho kraje a.s.	Pardubice	Czechia
Miejskie Centrum Medyczne Im. Dr. Karola Jonschera W Lodzi	Lodz	Poland
University Hospital Jena KöR	Jena	Germany

Other Sites

Site Name	City	Country
Katholisches Klinikum Bochum gGmbH	Bochum	Germany
Krajska zdravotni a.s.	Teplice	Czechia
Centrum Medyczne Neuromed Sp. z o.o.	Bydgoszcz	Poland
Neuroprotect Sp. z o.o.	Warsaw	Poland
Ma-Lek Clinical Sp. z o.o.	Katowice	Poland
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia
Pratia S.A.	Skorzewo	Poland
Vseobecna Fakultni Nemocnice V Praze	Prague	Czechia
Klinikum Wuerzburg Mitte gGmbH	Wuerzburg	Germany
Fakultni Thomayerova nemocnice	Prague	Czechia
Szpital Uniwersytecki w Krakowie	Cracow	Poland
Ujfelqnxddlphlaxhwxwu Evgbc Apu	Essen	Germany
Nmuuqnuldppc Brnkdeloy	Bielefeld	Germany
Nuwozlzqokeau Ghoizamcvavulobsqkj Kmhdhm uge Vicishf	Kassel	Germany
Ushbaeisktlehcemqeazr Musjrgkd Awp	Munster	Germany
Itevigrj Zmjsqwb Dk Bdkafzpstnvgoznjr	Oświęcim	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Recruiting	19.09.2025
Germany	Recruiting	19.09.2025
Poland	Recruiting	19.09.2025

Trial locations

BMS-986368 is an experimental medication that works by inhibiting two enzymes called FAAH and MAGL. It is being tested as an oral treatment (taken by mouth as a pill) for spasticity, which is a condition where muscles become stiff and difficult to control. This medication is specifically being studied in people who have Multiple Sclerosis (MS), a disease that affects the nervous system. The medication aims to help reduce muscle stiffness and improve movement control in MS patients.

Investigated diseases:

Multiple sclerosis

Multiple Sclerosis Spasticity – A condition that develops in people who have multiple sclerosis, causing muscle stiffness and involuntary muscle spasms. The spasticity occurs when there is damage to nerve pathways in the brain and spinal cord that control muscle movement and stretch reflexes. It typically affects the legs more than the arms, causing tightness, resistance to movement, and muscle cramping. The severity of spasticity can vary from mild muscle tightness to severe, painful, and uncontrollable muscle spasms. This condition can fluctuate throughout the day and may worsen with certain movements or positions.

Trial ID:

2024-517745-14-00

Protocol code:

IM045-1018

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of BMS-986368 to treat muscle stiffness in people with Multiple Sclerosis

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