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Study to Evaluate the Efficacy, Safety and Tolerability of BMS-986368, a FAAH/MAGL Inhibitor, in Participants with Multiple Sclerosis Spasticity
EU CTIS ID: 2024-517745-14-00
What this study is testing
The main goal (objective) of the study is to understand the effect of BMS-986368 compared with placebo (a pill with no medicine), on spasticity in patients with MS.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participants must be 18-70 years old who 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 (Screening).
- 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 (meaning moderate-significant disability) at Visit 1.
You likely can't join if
- Participants must not have had 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 (Randomization).
- Participants must not have a history of any substance abuse disorder. 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 cannabinoid-related products (including cannabis, CBD, or THC) within 30 days prior to Visit 1. Other protocol defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.