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

Fast replyInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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)
Step 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
Step 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
Step 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
Step 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 trial?

5 criteria

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 trial?

15 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Fakultni Nemocnice Hradec Kralove
Novy Hradec Kralove, Czechia
Verified
Fakultni Nemocnice U Sv Anny V Brne
Brno-Stred, Czechia
Responsive
Katholisches Klinikum Bochum gGmbH
Bochum, Germany

Trial locations

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Investigated drugs

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.

What is already known about the treatment

BMS-986368 - An oral medication being investigated as a dual FAAH/MAGL inhibitor for the treatment of spasticity in Multiple Sclerosis patients. This experimental drug works by inhibiting two enzymes (fatty acid amide hydrolase and monoacylglycerol lipase) involved in the endocannabinoid system, which plays a role in muscle tone regulation. Currently undergoing Phase 2 clinical trials, this medication represents a novel approach to managing MS-related spasticity through a mechanism that may help reduce muscle stiffness and improve mobility in patients. The drug is administered in oral form, making it potentially more convenient for patients compared to some existing treatment options.

Investigated diseases

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.