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

Last updated: March 23, 2026
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

2

Condition

Memory Loss

Neurologic Disorders

Multiple Sclerosis

Treatment

Placebo

BMS-986368

Clinical Study ID

NCT06782490
IM045-1018
  • Ages 18-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of BMS-986368 in participants with Multiple Sclerosis Spasticity

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
June 05, 2025
Estimated Completion Date:
June 09, 2027

Connect with a study center

  • John Hunter Hospital

    Newcastle, New South Wales 2305
    Australia

    Active - Recruiting

  • Local Institution - 0005

    Newcastle, New South Wales 2305
    Australia

    Site Not Available

  • Local Institution - 0004

    Sydney, New South Wales 2050
    Australia

    Site Not Available

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

    Sydney, New South Wales 2050
    Australia

    Active - Recruiting

  • John Hunter Hospital

    Newcastle 2155472, New South Wales 2155400 2305
    Australia

    Site Not Available

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

    Sydney 2147714, New South Wales 2155400 2050
    Australia

    Site Not Available

  • Centre for Neuroscience Innovation

    Kent Town, South Australia 5067
    Australia

    Active - Recruiting

  • Local Institution - 0030

    Kent Town, South Australia 5067
    Australia

    Site Not Available

  • Centre for Neuroscience Innovation

    Kent Town 8348490, South Australia 2061327 5067
    Australia

    Site Not Available

  • Local Institution - 0030

    Kent Town 8348490, South Australia 2061327 5067
    Australia

    Site Not Available

  • Box Hill Hospital

    Box Hill, Victoria 3128
    Australia

    Active - Recruiting

  • Local Institution - 0007

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Austin Health

    Heidelberg, Victoria 3084
    Australia

    Active - Recruiting

  • Local Institution - 0008

    Heidelberg, Victoria 3084
    Australia

    Site Not Available

  • Local Institution - 0006

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Parkville, Victoria 3050
    Australia

    Active - Recruiting

  • Box Hill Hospital

    Box Hill 2174360, Victoria 2145234 3128
    Australia

    Site Not Available

  • Local Institution - 0007

    Box Hill 2174360, Victoria 2145234 3128
    Australia

    Site Not Available

  • Austin Health

    Heidelberg 2163654, Victoria 2145234 3084
    Australia

    Site Not Available

  • Local Institution - 0006

    Parkville 2153770, Victoria 2145234 3050
    Australia

    Site Not Available

  • The Royal Melbourne Hospital

    Parkville 2153770, Victoria 2145234 3050
    Australia

    Site Not Available

  • Local Institution - 0019

    Nedlands, Western Australia 6009
    Australia

    Site Not Available

  • Perron Institute

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • Perron Institute

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • Local Institution - 0013

    Edmonton, Alberta T6G 2G3
    Canada

    Site Not Available

  • University Of Alberta Hospital

    Edmonton, Alberta T6G 2G3
    Canada

    Active - Recruiting

  • Local Institution - 0013

    Edmonton 5946768, Alberta 5883102 T6G 2G3
    Canada

    Site Not Available

  • University Of Alberta Hospital

    Edmonton 5946768, Alberta 5883102 T6G 2G3
    Canada

    Site Not Available

  • Local Institution - 0024

    London, Ontario N6A 5A5
    Canada

    Site Not Available

  • University Hospital - London Health Sciences Centre

    London, Ontario N6A 5A5
    Canada

    Active - Recruiting

  • Local Institution - 0012

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Local Institution - 0028

    Toronto, Ontario M5B 1W8
    Canada

    Site Not Available

  • Local Institution - 0024

    London 6058560, Ontario 6093943 N6A 5A5
    Canada

    Site Not Available

  • University Hospital - London Health Sciences Centre

    London 6058560, Ontario 6093943 N6A 5A5
    Canada

    Site Not Available

  • Local Institution - 0012

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • The Ottawa Hospital - General Campus

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • Local Institution - 0028

    Toronto 6167865, Ontario 6093943 M5B 1W8
    Canada

    Site Not Available

  • Centre de Recherche Saint-Louis

    Lévis, Quebec G6W0M5
    Canada

    Active - Recruiting

  • Local Institution - 0014

    Lévis, Quebec G6W0M5
    Canada

    Site Not Available

  • Local Institution - 0029

    Montreal, Quebec H3A2B4
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec H3A2B4
    Canada

    Active - Recruiting

  • Centre de Recherche Saint-Louis

    Lévis 6325521, Quebec 6115047 G6W0M5
    Canada

    Site Not Available

  • Montreal Neurological Institute and Hospital

    Montreal 6077243, Quebec 6115047 H3A2B4
    Canada

    Site Not Available

  • Fakultni Nemocnice u sv. Anny v Brne

    Brno, Brno-město 656 91
    Czechia

    Active - Recruiting

  • Local Institution - 0055

    Brno, Brno-město 656 91
    Czechia

    Site Not Available

  • Fakultni Nemocnice u sv. Anny v Brne

    Brno 3078610, Brno-město 656 91
    Czechia

    Site Not Available

  • Local Institution - 0055

    Brno 3078610, Brno-město 656 91
    Czechia

    Site Not Available

  • Local Institution - 0010

    Hradec Kralove, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Local Institution - 0010

    Hradec Králové, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Local Institution - 0010

    Hradec Králové 3074967, Hradec Králové 500 05
    Czechia

    Site Not Available

  • Local Institution - 0054

    Prague, Praha 2 12111
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Prague, Praha 2 12111
    Czechia

    Active - Recruiting

  • Local Institution - 0054

    Prague 3067696, Praha 2 12111
    Czechia

    Site Not Available

  • Vseobecna fakultni nemocnice v Praze

    Prague 3067696, Praha 2 12111
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4 14059
    Czechia

    Active - Recruiting

  • Local Institution - 0059

    Prague, Praha 4 14059
    Czechia

    Site Not Available

  • Fakultni Thomayerova nemocnice

    Prague 3067696, Praha 4 14059
    Czechia

    Active - Recruiting

  • Local Institution - 0059

    Prague 3067696, Praha 4 14059
    Czechia

    Site Not Available

  • Local Institution - 0011

    Prague, Praha 5 150 06
    Czechia

    Site Not Available

  • Local Institution - 0011

    Prague 3067696, Praha 5 150 06
    Czechia

    Site Not Available

  • Local Institution - 0011

    Praha, Praha 5 150 06
    Czechia

    Site Not Available

  • Local Institution - 0009

    Teplice, Ústecký Kraj 415 01
    Czechia

    Site Not Available

  • Nemocnice Teplice

    Teplice, Ústecký kraj 415 01
    Czechia

    Active - Recruiting

  • Local Institution - 0009

    Teplice 3064288, Ústecký kraj 3339577 415 01
    Czechia

    Site Not Available

  • Local Institution - 0053

    Pardubice, 532 03
    Czechia

    Site Not Available

  • Nemocnice Pardubického kraje

    Pardubice, 532 03
    Czechia

    Active - Recruiting

  • Local Institution - 0053

    Pardubice 3068582, 532 03
    Czechia

    Site Not Available

  • Nemocnice Pardubického kraje

    Pardubice 3068582, 532 03
    Czechia

    Site Not Available

  • Klinikum Würzburg Mitte

    Würzburg, Bavaria 97074
    Germany

    Active - Recruiting

  • Klinikum Würzburg Mitte

    Würzburg 2805615, Bavaria 2951839 97074
    Germany

    Site Not Available

  • Local Institution - 0052

    Würzburg 2805615, Bavaria 2951839 97074
    Germany

    Site Not Available

  • Local Institution - 0052

    Wuerzburg, Bayern 97074
    Germany

    Site Not Available

  • Neurologischen Gemeinschaftspraxis Kassel und Vellmar

    Kassel, Hesse 34121
    Germany

    Active - Recruiting

  • Local Institution - 0022

    Kassel 2892518, Hesse 2905330 34121
    Germany

    Site Not Available

  • Neurologischen Gemeinschaftspraxis Kassel und Vellmar

    Kassel 2892518, Hesse 2905330 34121
    Germany

    Site Not Available

  • Local Institution - 0022

    Kassel, Hessen 34121
    Germany

    Site Not Available

  • Local Institution - 0027

    Bochum, Nordrhein-Westfalen 44791
    Germany

    Site Not Available

  • St. Josef und St. Elisabeth Hospital gGmbH

    Bochum, North Rhine-Westphalia 44791
    Germany

    Active - Recruiting

  • Local Institution - 0060

    Münster, North Rhine-Westphalia 48149
    Germany

    Site Not Available

  • Local Institution - 0027

    Bochum 2947416, North Rhine-Westphalia 2861876 44791
    Germany

    Site Not Available

  • St. Josef und St. Elisabeth Hospital gGmbH

    Bochum 2947416, North Rhine-Westphalia 2861876 44791
    Germany

    Site Not Available

  • Local Institution - 0060

    Münster 2867543, North Rhine-Westphalia 2861876 48149
    Germany

    Site Not Available

  • Local Institution - 0031

    Meisenheim, Rhineland-Palatinate 55590
    Germany

    Site Not Available

  • Local Institution - 0031

    Meisenheim 2872173, Rhineland-Palatinate 2847618 55590
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena, Thuringia 07747
    Germany

    Active - Recruiting

  • Local Institution - 0023

    Jena 2895044, Thuringia 2822542 07747
    Germany

    Site Not Available

  • Universitätsklinikum Jena

    Jena 2895044, Thuringia 2822542 07747
    Germany

    Site Not Available

  • Local Institution - 0023

    Jena, Thüringen 07747
    Germany

    Site Not Available

  • Local Institution - 0051

    Bielefeld, 33647
    Germany

    Site Not Available

  • Neurozentrum Bielefeld

    Bielefeld, 33647
    Germany

    Active - Recruiting

  • Local Institution - 0051

    Bielefeld 2949186, 33647
    Germany

    Site Not Available

  • Neurozentrum Bielefeld

    Bielefeld 2949186, 33647
    Germany

    Site Not Available

  • Local Institution - 0021

    Dresden, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden, 01307
    Germany

    Active - Recruiting

  • Local Institution - 0021

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Universitaetsklinikum Carl Gustav Carus Dresden

    Dresden 2935022, 01307
    Germany

    Site Not Available

  • Local Institution - 0020

    Essen, 45122
    Germany

    Site Not Available

  • Local Institution - 0020

    Essen 2928810, 45122
    Germany

    Site Not Available

  • Local Institution - 0057

    Bydgoszcz, Kujawsko-pomorskie 85-163
    Poland

    Site Not Available

  • Centrum Medyczne NEUROMED

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-163
    Poland

    Active - Recruiting

  • Local Institution - 0044

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796
    Poland

    Site Not Available

  • Centrum Medyczne NEUROMED

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-163
    Poland

    Site Not Available

  • Local Institution - 0044

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-796
    Poland

    Site Not Available

  • Local Institution - 0057

    Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-163
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow, Lesser Poland Voivodeship 30-727
    Poland

    Active - Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow, Lesser Poland Voivodeship 31-503
    Poland

    Active - Recruiting

  • Instytut Zdrowia Dr Boczarska Jedynak

    Oświęcim, Lesser Poland Voivodeship 32-600
    Poland

    Active - Recruiting

  • Local Institution - 0046

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
    Poland

    Site Not Available

  • Local Institution - 0056

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-503
    Poland

    Site Not Available

  • Pratia MCM Krakow

    Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
    Poland

    Active - Recruiting

  • SP ZOZ Szpital Uniwersytecki w Krakowie

    Krakow 3094802, Lesser Poland Voivodeship 858786 31-503
    Poland

    Site Not Available

  • Instytut Zdrowia Dr Boczarska Jedynak

    Oświęcim 3089658, Lesser Poland Voivodeship 858786 32-600
    Poland

    Site Not Available

  • Local Institution - 0048

    Oświęcim 3089658, Lesser Poland Voivodeship 858786 32-600
    Poland

    Site Not Available

  • Local Institution - 0070

    Lódz, Lódzkie 93-414
    Poland

    Site Not Available

  • Local Institution - 0047

    Warszawa, MZ 01-684
    Poland

    Site Not Available

  • Centrum Medyczne NeuroProtect

    Warsaw, Masovian Voivodeship 01-684
    Poland

    Active - Recruiting

  • Centrum Medyczne NeuroProtect

    Warsaw 756135, Masovian Voivodeship 858787 01-684
    Poland

    Site Not Available

  • Local Institution - 0047

    Warsaw 756135, Masovian Voivodeship 858787 01-684
    Poland

    Site Not Available

  • Local Institution - 0046

    Kraków, Małopolskie 30-727
    Poland

    Site Not Available

  • Local Institution - 0056

    Kraków, Małopolskie 31-503
    Poland

    Site Not Available

  • Local Institution - 0048

    Oswiecim, Małopolskie 32-600
    Poland

    Site Not Available

  • Local Institution - 0045

    Katowice, Śląskie 40-571
    Poland

    Site Not Available

  • Local Institution - 0061

    Gdansk, 80-952
    Poland

    Site Not Available

  • Local Institution - 0061

    Gdansk 3099434, 80-952
    Poland

    Site Not Available

  • Local Institution - 0061

    Gdańsk, 80-952
    Poland

    Site Not Available

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

    Katowice, 40-571
    Poland

    Active - Recruiting

  • Local Institution - 0045

    Katowice 3096472, 40-571
    Poland

    Site Not Available

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

    Katowice 3096472, 40-571
    Poland

    Site Not Available

  • Local Institution - 0051

    Slomniki, 32-090
    Poland

    Site Not Available

  • Local Institution - 0051

    Słomniki, 32-090
    Poland

    Site Not Available

  • Local Institution - 0051

    Słomniki 758905, 32-090
    Poland

    Site Not Available

  • Local Institution - 0058

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Puerto Rico Multiple Sclerosis Center

    Caguas, 00725
    Puerto Rico

    Active - Recruiting

  • Puerto Rico Multiple Sclerosis Center

    Caguas 4563008, 00725
    Puerto Rico

    Site Not Available

  • Local Institution - 0033

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Local Institution - 0033

    Birmingham 4049979, Alabama 4829764 35209
    United States

    Site Not Available

  • Local Institution - 0050

    Scottsdale, Arizona 85253
    United States

    Site Not Available

  • Perseverance Research Center,LLC

    Scottsdale, Arizona 85253
    United States

    Active - Recruiting

  • Perseverance Research Center,LLC

    Scottsdale 5313457, Arizona 5551752 85253
    United States

    Site Not Available

  • Local Institution - 0017

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Local Institution - 0017

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Aqualane Clinical Research

    Naples, Florida 34105
    United States

    Active - Recruiting

  • Local Institution - 0015

    Tampa, Florida 33612
    United States

    Site Not Available

  • USF Health

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Aqualane Clinical Research

    Naples 4165565, Florida 4155751 34105
    United States

    Site Not Available

  • Local Institution - 0068

    Naples 4165565, Florida 4155751 34105
    United States

    Site Not Available

  • Local Institution - 0015

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • USF Health

    Tampa 4174757, Florida 4155751 33612
    United States

    Site Not Available

  • Local Institution - 0016

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City 4273837, Kansas 4273857 66160
    United States

    Site Not Available

  • Local Institution - 0049

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Neurology Center of New England

    Foxboro, Massachusetts 02035
    United States

    Site Not Available

  • Neurology Center of New England

    Foxborough, Massachusetts 02035
    United States

    Active - Recruiting

  • Neurology Center of New England

    Foxborough 4937222, Massachusetts 6254926 02035
    United States

    Site Not Available

  • Local Institution - 0018

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Washington University School of Medicine

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Local Institution - 0002

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Local Institution - 0039

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Local Institution - 0069

    Columbus, Ohio 43235
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati 4508722, Ohio 5165418 45219
    United States

    Site Not Available

  • Local Institution - 0039

    Columbus 4509177, Ohio 5165418 43214
    United States

    Site Not Available

  • Local Institution - 0069

    Columbus 4509177, Ohio 5165418 43235
    United States

    Site Not Available

  • Local Institution - 0067

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Local Institution - 0067

    Philadelphia 4560349, Pennsylvania 6254927 19107
    United States

    Site Not Available

  • Hope Neurology

    Knoxville, Tennessee 37922
    United States

    Active - Recruiting

  • Local Institution - 0003

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Hope Neurology

    Knoxville 4634946, Tennessee 4662168 37922
    United States

    Site Not Available

  • EvergreenHealth Medical Center

    Kirkland, Washington 98034
    United States

    Active - Recruiting

  • Local Institution - 0001

    Kirkland, Washington 98034
    United States

    Site Not Available

  • EvergreenHealth Medical Center

    Kirkland 5799841, Washington 5815135 98034
    United States

    Site Not Available

  • Local Institution - 0001

    Kirkland 5799841, Washington 5815135 98034
    United States

    Site Not Available

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