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

Официальное название

A Phase 2, Randomized, Double-Blind, Four-Arm, Placebo-Controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Three Doses of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Spasticity in Participants With Multiple Sclerosis (BALANCE-MSS-1)

Обзор

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

Вмешательства

• Препарат BMS-986368
  Specified dose on specified days
• Препарат Placebo
  Specified dose on specified days

Первичные конечные точки

• Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score [Срок оценки: At week 6]

Вторичные конечные точки (12)

• Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score [Срок оценки: At week 6]
• Change from baseline on the MS Spasticity Scale (MSSS-88) total scores [Срок оценки: At week 6]
• Change from baseline on the Timed 25-Foot Walk (T25FW) score [Срок оценки: At week 6]
• Change from baseline on the Clinical Global Impression of Severity (CGI-S) score [Срок оценки: At week 6]
• Plasma concentrations of BMS-986368 at selected pre- and post-dose time points [Срок оценки: Up to week 6]
• Number of participants with Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to week 16]
• Serious adverse events (SAEs) [Срок оценки: Up to week 16]
• Adverse events (AEs) leading to treatment discontinuation [Срок оценки: Up to week 16]
• AEs leading to death [Срок оценки: Up to week 16]
• AEs leading to clinically significant lab abnormalities [Срок оценки: Up to week 16]
• Number of participants with suicidal ideation and behavior during BMS-986368 administration as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) [Срок оценки: Up to week 16]
• Number of participants with withdrawal symptoms following BMS-986368 administration as assessed by the Cannabis Withdrawal Scale (CWS) [Срок оценки: Up to week 15]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 15 центров

• Alabama Neurology Associates — Birmingham
• Perseverance Research Center,LLC — Scottsdale
• Local Institution - 0017 — Aurora
• Aqualane Clinical Research — Naples
• USF Health — Tampa
• University of Kansas Medical Center — Kansas City
• Neurology Center of New England — Foxborough
• Local Institution - 0071 — Southfield
• … и ещё 7 центров

Германия · 9 центров

• Klinikum Würzburg Mitte — Würzburg
• Neurologischen Gemeinschaftspraxis Kassel und Vellmar — Kassel
• St. Josef und St. Elisabeth Hospital gGmbH — Bochum
• Universitätsklinikum Münster - Albert Schweitzer Campus — Münster
• Local Institution - 0031 — Meisenheim
• Universitätsklinikum Jena — Jena
• Neurozentrum Bielefeld — Bielefeld
• Universitaetsklinikum Carl Gustav Carus Dresden — Dresden
• … и ещё 1 центр

Польша · 9 центров

• Centrum Medyczne NEUROMED — Bydgoszcz
• Local Institution - 0044 — Bydgoszcz
• Pratia MCM Krakow — Krakow
• SP ZOZ Szpital Uniwersytecki w Krakowie — Krakow
• Instytut Zdrowia Dr Boczarska Jedynak — Oświęcim
• Centrum Medyczne NeuroProtect — Warsaw
• Local Institution - 0061 — Gdansk
• M.A. - LEK A.M. Maciejowscy S.C., Centrum Terapii SM — Katowice
• … и ещё 1 центр

Австралия · 7 центров

• John Hunter Hospital — Newcastle
• University of Sydney - Brain and Mind Research Institute (BMRI) — Sydney
• Centre for Neuroscience Innovation — Kent Town
• Box Hill Hospital — Box Hill
• Austin Health — Heidelberg
• The Royal Melbourne Hospital — Parkville
• Perron Institute — Nedlands

Чехия · 7 центров

• Fakultni Nemocnice u sv. Anny v Brne — Brno
• Fakultni nemocnice Hradec Kralove — Hradec Králové
• Vseobecna fakultni nemocnice v Praze — Prague
• Fakultni Thomayerova nemocnice — Prague
• Local Institution - 0011 — Prague
• Nemocnice Pardubického kraje — Pardubice
• Nemocnice Teplice — Teplice

Канада · 6 центров

• University Of Alberta Hospital — Edmonton
• University Hospital - London Health Sciences Centre — London
• The Ottawa Hospital - General Campus — Ottawa
• Unity Health Toronto, St. Michael's Hospital — Toronto
• Centre de Recherche Saint-Louis — Lévis
• Montreal Neurological Institute and Hospital — Montreal

Пуэрто-Рико · 1 центр

• Puerto Rico Multiple Sclerosis Center — Caguas

Идентификаторы

NCT: NCT06782490 · IM045-1018

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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