Phase
Condition
Memory Loss
Neurologic Disorders
Multiple Sclerosis
Treatment
Placebo
BMS-986368
Clinical Study ID
Ages 18-70 All Genders
Study Summary
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
Connect with a study center
John Hunter Hospital
Newcastle, New South Wales 2305
AustraliaActive - Recruiting
Local Institution - 0005
Newcastle, New South Wales 2305
AustraliaSite Not Available
Local Institution - 0004
Sydney, New South Wales 2050
AustraliaSite Not Available
University of Sydney - Brain and Mind Research Institute (BMRI)
Sydney, New South Wales 2050
AustraliaActive - Recruiting
John Hunter Hospital
Newcastle 2155472, New South Wales 2155400 2305
AustraliaSite Not Available
University of Sydney - Brain and Mind Research Institute (BMRI)
Sydney 2147714, New South Wales 2155400 2050
AustraliaSite Not Available
Centre for Neuroscience Innovation
Kent Town, South Australia 5067
AustraliaActive - Recruiting
Local Institution - 0030
Kent Town, South Australia 5067
AustraliaSite Not Available
Centre for Neuroscience Innovation
Kent Town 8348490, South Australia 2061327 5067
AustraliaSite Not Available
Local Institution - 0030
Kent Town 8348490, South Australia 2061327 5067
AustraliaSite Not Available
Box Hill Hospital
Box Hill, Victoria 3128
AustraliaActive - Recruiting
Local Institution - 0007
Box Hill, Victoria 3128
AustraliaSite Not Available
Austin Health
Heidelberg, Victoria 3084
AustraliaActive - Recruiting
Local Institution - 0008
Heidelberg, Victoria 3084
AustraliaSite Not Available
Local Institution - 0006
Parkville, Victoria 3050
AustraliaSite Not Available
The Royal Melbourne Hospital
Parkville, Victoria 3050
AustraliaActive - Recruiting
Box Hill Hospital
Box Hill 2174360, Victoria 2145234 3128
AustraliaSite Not Available
Local Institution - 0007
Box Hill 2174360, Victoria 2145234 3128
AustraliaSite Not Available
Austin Health
Heidelberg 2163654, Victoria 2145234 3084
AustraliaSite Not Available
Local Institution - 0006
Parkville 2153770, Victoria 2145234 3050
AustraliaSite Not Available
The Royal Melbourne Hospital
Parkville 2153770, Victoria 2145234 3050
AustraliaSite Not Available
Local Institution - 0019
Nedlands, Western Australia 6009
AustraliaSite Not Available
Perron Institute
Nedlands, Western Australia 6009
AustraliaActive - Recruiting
Perron Institute
Nedlands 2064874, Western Australia 2058645 6009
AustraliaSite Not Available
Local Institution - 0013
Edmonton, Alberta T6G 2G3
CanadaSite Not Available
University Of Alberta Hospital
Edmonton, Alberta T6G 2G3
CanadaActive - Recruiting
Local Institution - 0013
Edmonton 5946768, Alberta 5883102 T6G 2G3
CanadaSite Not Available
University Of Alberta Hospital
Edmonton 5946768, Alberta 5883102 T6G 2G3
CanadaSite Not Available
Local Institution - 0024
London, Ontario N6A 5A5
CanadaSite Not Available
University Hospital - London Health Sciences Centre
London, Ontario N6A 5A5
CanadaActive - Recruiting
Local Institution - 0012
Ottawa, Ontario K1H 8L6
CanadaSite Not Available
The Ottawa Hospital - General Campus
Ottawa, Ontario K1H 8L6
CanadaActive - Recruiting
Local Institution - 0028
Toronto, Ontario M5B 1W8
CanadaSite Not Available
Local Institution - 0024
London 6058560, Ontario 6093943 N6A 5A5
CanadaSite Not Available
University Hospital - London Health Sciences Centre
London 6058560, Ontario 6093943 N6A 5A5
CanadaSite Not Available
Local Institution - 0012
Ottawa 6094817, Ontario 6093943 K1H 8L6
CanadaSite Not Available
The Ottawa Hospital - General Campus
Ottawa 6094817, Ontario 6093943 K1H 8L6
CanadaSite Not Available
Local Institution - 0028
Toronto 6167865, Ontario 6093943 M5B 1W8
CanadaSite Not Available
Centre de Recherche Saint-Louis
Lévis, Quebec G6W0M5
CanadaActive - Recruiting
Local Institution - 0014
Lévis, Quebec G6W0M5
CanadaSite Not Available
Local Institution - 0029
Montreal, Quebec H3A2B4
CanadaSite Not Available
Montreal Neurological Institute and Hospital
Montreal, Quebec H3A2B4
CanadaActive - Recruiting
Centre de Recherche Saint-Louis
Lévis 6325521, Quebec 6115047 G6W0M5
CanadaSite Not Available
Montreal Neurological Institute and Hospital
Montreal 6077243, Quebec 6115047 H3A2B4
CanadaSite Not Available
Fakultni Nemocnice u sv. Anny v Brne
Brno, Brno-město 656 91
CzechiaActive - Recruiting
Local Institution - 0055
Brno, Brno-město 656 91
CzechiaSite Not Available
Fakultni Nemocnice u sv. Anny v Brne
Brno 3078610, Brno-město 656 91
CzechiaSite Not Available
Local Institution - 0055
Brno 3078610, Brno-město 656 91
CzechiaSite Not Available
Local Institution - 0010
Hradec Kralove, Hradec Králové 500 05
CzechiaSite Not Available
Local Institution - 0010
Hradec Králové, Hradec Králové 500 05
CzechiaSite Not Available
Local Institution - 0010
Hradec Králové 3074967, Hradec Králové 500 05
CzechiaSite Not Available
Local Institution - 0054
Prague, Praha 2 12111
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Prague, Praha 2 12111
CzechiaActive - Recruiting
Local Institution - 0054
Prague 3067696, Praha 2 12111
CzechiaSite Not Available
Vseobecna fakultni nemocnice v Praze
Prague 3067696, Praha 2 12111
CzechiaSite Not Available
Fakultni Thomayerova nemocnice
Prague, Praha 4 14059
CzechiaActive - Recruiting
Local Institution - 0059
Prague, Praha 4 14059
CzechiaSite Not Available
Fakultni Thomayerova nemocnice
Prague 3067696, Praha 4 14059
CzechiaActive - Recruiting
Local Institution - 0059
Prague 3067696, Praha 4 14059
CzechiaSite Not Available
Local Institution - 0011
Prague, Praha 5 150 06
CzechiaSite Not Available
Local Institution - 0011
Prague 3067696, Praha 5 150 06
CzechiaSite Not Available
Local Institution - 0011
Praha, Praha 5 150 06
CzechiaSite Not Available
Local Institution - 0009
Teplice, Ústecký Kraj 415 01
CzechiaSite Not Available
Nemocnice Teplice
Teplice, Ústecký kraj 415 01
CzechiaActive - Recruiting
Local Institution - 0009
Teplice 3064288, Ústecký kraj 3339577 415 01
CzechiaSite Not Available
Local Institution - 0053
Pardubice, 532 03
CzechiaSite Not Available
Nemocnice Pardubického kraje
Pardubice, 532 03
CzechiaActive - Recruiting
Local Institution - 0053
Pardubice 3068582, 532 03
CzechiaSite Not Available
Nemocnice Pardubického kraje
Pardubice 3068582, 532 03
CzechiaSite Not Available
Klinikum Würzburg Mitte
Würzburg, Bavaria 97074
GermanyActive - Recruiting
Klinikum Würzburg Mitte
Würzburg 2805615, Bavaria 2951839 97074
GermanySite Not Available
Local Institution - 0052
Würzburg 2805615, Bavaria 2951839 97074
GermanySite Not Available
Local Institution - 0052
Wuerzburg, Bayern 97074
GermanySite Not Available
Neurologischen Gemeinschaftspraxis Kassel und Vellmar
Kassel, Hesse 34121
GermanyActive - Recruiting
Local Institution - 0022
Kassel 2892518, Hesse 2905330 34121
GermanySite Not Available
Neurologischen Gemeinschaftspraxis Kassel und Vellmar
Kassel 2892518, Hesse 2905330 34121
GermanySite Not Available
Local Institution - 0022
Kassel, Hessen 34121
GermanySite Not Available
Local Institution - 0027
Bochum, Nordrhein-Westfalen 44791
GermanySite Not Available
St. Josef und St. Elisabeth Hospital gGmbH
Bochum, North Rhine-Westphalia 44791
GermanyActive - Recruiting
Local Institution - 0060
Münster, North Rhine-Westphalia 48149
GermanySite Not Available
Local Institution - 0027
Bochum 2947416, North Rhine-Westphalia 2861876 44791
GermanySite Not Available
St. Josef und St. Elisabeth Hospital gGmbH
Bochum 2947416, North Rhine-Westphalia 2861876 44791
GermanySite Not Available
Local Institution - 0060
Münster 2867543, North Rhine-Westphalia 2861876 48149
GermanySite Not Available
Local Institution - 0031
Meisenheim, Rhineland-Palatinate 55590
GermanySite Not Available
Local Institution - 0031
Meisenheim 2872173, Rhineland-Palatinate 2847618 55590
GermanySite Not Available
Universitätsklinikum Jena
Jena, Thuringia 07747
GermanyActive - Recruiting
Local Institution - 0023
Jena 2895044, Thuringia 2822542 07747
GermanySite Not Available
Universitätsklinikum Jena
Jena 2895044, Thuringia 2822542 07747
GermanySite Not Available
Local Institution - 0023
Jena, Thüringen 07747
GermanySite Not Available
Local Institution - 0051
Bielefeld, 33647
GermanySite Not Available
Neurozentrum Bielefeld
Bielefeld, 33647
GermanyActive - Recruiting
Local Institution - 0051
Bielefeld 2949186, 33647
GermanySite Not Available
Neurozentrum Bielefeld
Bielefeld 2949186, 33647
GermanySite Not Available
Local Institution - 0021
Dresden, 01307
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanyActive - Recruiting
Local Institution - 0021
Dresden 2935022, 01307
GermanySite Not Available
Universitaetsklinikum Carl Gustav Carus Dresden
Dresden 2935022, 01307
GermanySite Not Available
Local Institution - 0020
Essen, 45122
GermanySite Not Available
Local Institution - 0020
Essen 2928810, 45122
GermanySite Not Available
Local Institution - 0057
Bydgoszcz, Kujawsko-pomorskie 85-163
PolandSite Not Available
Centrum Medyczne NEUROMED
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-163
PolandActive - Recruiting
Local Institution - 0044
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796
PolandSite Not Available
Centrum Medyczne NEUROMED
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-163
PolandSite Not Available
Local Institution - 0044
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-796
PolandSite Not Available
Local Institution - 0057
Bydgoszcz 3102014, Kuyavian-Pomeranian Voivodeship 3337500 85-163
PolandSite Not Available
Pratia MCM Krakow
Krakow, Lesser Poland Voivodeship 30-727
PolandActive - Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow, Lesser Poland Voivodeship 31-503
PolandActive - Recruiting
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim, Lesser Poland Voivodeship 32-600
PolandActive - Recruiting
Local Institution - 0046
Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
PolandSite Not Available
Local Institution - 0056
Krakow 3094802, Lesser Poland Voivodeship 858786 31-503
PolandSite Not Available
Pratia MCM Krakow
Krakow 3094802, Lesser Poland Voivodeship 858786 30-727
PolandActive - Recruiting
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow 3094802, Lesser Poland Voivodeship 858786 31-503
PolandSite Not Available
Instytut Zdrowia Dr Boczarska Jedynak
Oświęcim 3089658, Lesser Poland Voivodeship 858786 32-600
PolandSite Not Available
Local Institution - 0048
Oświęcim 3089658, Lesser Poland Voivodeship 858786 32-600
PolandSite Not Available
Local Institution - 0070
Lódz, Lódzkie 93-414
PolandSite Not Available
Local Institution - 0047
Warszawa, MZ 01-684
PolandSite Not Available
Centrum Medyczne NeuroProtect
Warsaw, Masovian Voivodeship 01-684
PolandActive - Recruiting
Centrum Medyczne NeuroProtect
Warsaw 756135, Masovian Voivodeship 858787 01-684
PolandSite Not Available
Local Institution - 0047
Warsaw 756135, Masovian Voivodeship 858787 01-684
PolandSite Not Available
Local Institution - 0046
Kraków, Małopolskie 30-727
PolandSite Not Available
Local Institution - 0056
Kraków, Małopolskie 31-503
PolandSite Not Available
Local Institution - 0048
Oswiecim, Małopolskie 32-600
PolandSite Not Available
Local Institution - 0045
Katowice, Śląskie 40-571
PolandSite Not Available
Local Institution - 0061
Gdansk, 80-952
PolandSite Not Available
Local Institution - 0061
Gdansk 3099434, 80-952
PolandSite Not Available
Local Institution - 0061
Gdańsk, 80-952
PolandSite Not Available
M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM
Katowice, 40-571
PolandActive - Recruiting
Local Institution - 0045
Katowice 3096472, 40-571
PolandSite Not Available
M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM
Katowice 3096472, 40-571
PolandSite Not Available
Local Institution - 0051
Slomniki, 32-090
PolandSite Not Available
Local Institution - 0051
Słomniki, 32-090
PolandSite Not Available
Local Institution - 0051
Słomniki 758905, 32-090
PolandSite Not Available
Local Institution - 0058
Caguas, 00725
Puerto RicoSite Not Available
Puerto Rico Multiple Sclerosis Center
Caguas, 00725
Puerto RicoActive - Recruiting
Puerto Rico Multiple Sclerosis Center
Caguas 4563008, 00725
Puerto RicoSite Not Available
Local Institution - 0033
Birmingham, Alabama 35209
United StatesSite Not Available
Local Institution - 0033
Birmingham 4049979, Alabama 4829764 35209
United StatesSite Not Available
Local Institution - 0050
Scottsdale, Arizona 85253
United StatesSite Not Available
Perseverance Research Center,LLC
Scottsdale, Arizona 85253
United StatesActive - Recruiting
Perseverance Research Center,LLC
Scottsdale 5313457, Arizona 5551752 85253
United StatesSite Not Available
Local Institution - 0017
Aurora, Colorado 80045
United StatesSite Not Available
Local Institution - 0017
Aurora 5412347, Colorado 5417618 80045
United StatesSite Not Available
Aqualane Clinical Research
Naples, Florida 34105
United StatesActive - Recruiting
Local Institution - 0015
Tampa, Florida 33612
United StatesSite Not Available
USF Health
Tampa, Florida 33612
United StatesActive - Recruiting
Aqualane Clinical Research
Naples 4165565, Florida 4155751 34105
United StatesSite Not Available
Local Institution - 0068
Naples 4165565, Florida 4155751 34105
United StatesSite Not Available
Local Institution - 0015
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
USF Health
Tampa 4174757, Florida 4155751 33612
United StatesSite Not Available
Local Institution - 0016
Kansas City, Kansas 66160
United StatesSite Not Available
University of Kansas Medical Center
Kansas City, Kansas 66160
United StatesActive - Recruiting
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
United StatesSite Not Available
Local Institution - 0049
Foxboro, Massachusetts 02035
United StatesSite Not Available
Neurology Center of New England
Foxboro, Massachusetts 02035
United StatesSite Not Available
Neurology Center of New England
Foxborough, Massachusetts 02035
United StatesActive - Recruiting
Neurology Center of New England
Foxborough 4937222, Massachusetts 6254926 02035
United StatesSite Not Available
Local Institution - 0018
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesSite Not Available
Washington University School of Medicine
St Louis, Missouri 63110
United StatesActive - Recruiting
Washington University School of Medicine
St Louis 4407066, Missouri 4398678 63110
United StatesSite Not Available
Local Institution - 0002
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Local Institution - 0039
Columbus, Ohio 43214
United StatesSite Not Available
Local Institution - 0069
Columbus, Ohio 43235
United StatesSite Not Available
University of Cincinnati Medical Center
Cincinnati 4508722, Ohio 5165418 45219
United StatesSite Not Available
Local Institution - 0039
Columbus 4509177, Ohio 5165418 43214
United StatesSite Not Available
Local Institution - 0069
Columbus 4509177, Ohio 5165418 43235
United StatesSite Not Available
Local Institution - 0067
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Local Institution - 0067
Philadelphia 4560349, Pennsylvania 6254927 19107
United StatesSite Not Available
Hope Neurology
Knoxville, Tennessee 37922
United StatesActive - Recruiting
Local Institution - 0003
Knoxville, Tennessee 37922
United StatesSite Not Available
Hope Neurology
Knoxville 4634946, Tennessee 4662168 37922
United StatesSite Not Available
EvergreenHealth Medical Center
Kirkland, Washington 98034
United StatesActive - Recruiting
Local Institution - 0001
Kirkland, Washington 98034
United StatesSite Not Available
EvergreenHealth Medical Center
Kirkland 5799841, Washington 5815135 98034
United StatesSite Not Available
Local Institution - 0001
Kirkland 5799841, Washington 5815135 98034
United StatesSite Not Available

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