Health Trials

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

ConditionMultiple Sclerosis Spasticity
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCelgene

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986368

    Drug

    Specified dose on specified days

  • Placebo

    Drug

    Specified dose on specified days

Treatment groups

200 Participants
are divided into 4 treatment groups
Group A: Administration of BMS-986368 Dose AExperimental treatment 1 intervention
Group B: Administration of BMS-986368 Dose BExperimental treatment 1 intervention
Group C: Administration of BMS-986368 Dose CExperimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from baseline in Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) score

Time frame
At week 6

Secondary outcomes

1

Change from baseline on the Numeric Rating Scale Spasticity (NRS-S) score

Time frame
At week 6
2

Change from baseline on the MS Spasticity Scale (MSSS-88) total scores

Time frame
At week 6
3

Change from baseline on the Timed 25-Foot Walk (T25FW) score

Time frame
At week 6
4

Change from baseline on the Clinical Global Impression of Severity (CGI-S) score

Time frame
At week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Celgene

Lead sponsor

Source ClinicalTrials.gov
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