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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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517745-14-00
Acronym
IM045-1018
Enrollment
100
Registered
2025-09-08
Start date
2025-09-24
Completion date
Unknown
Last updated
2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis Spasticity

Brief summary

The way we are measuring the main study goals (the main trial endpoint) is by looking at how much the stiffness in the person's most affected leg changes from the start of the study to the end of Week 6. We will use a tool called the Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) to measure this

Detailed description

The secondary trial endpoints include the Numeric Rating Scale-Spasticity (NRS-S), which is a question answered every day using an eDiary provided to the participant., Other secondary endpoints include the MS Spasticity Scale (MSSS-88), a set of questions asking about spasticity in the participant’s daily life, the Timed 25-Foot Walk (T25FW) test, a test to see how long it takes the participant to walk 25 feet, and the Clinical Global Impression of Severity, a question for the investigator to determine how severe the participant’s condition is.

Interventions

DRUGCC-97489 1mg
DRUGCC-97489 3mg

Sponsors

Celgene Corp.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The way we are measuring the main study goals (the main trial endpoint) is by looking at how much the stiffness in the person's most affected leg changes from the start of the study to the end of Week 6. We will use a tool called the Total Numeric-transformed Modified Ashworth Scale-Most Affected Lower Limb (TNmAS-MALL) to measure this

Secondary

MeasureTime frame
The secondary trial endpoints include the Numeric Rating Scale-Spasticity (NRS-S), which is a question answered every day using an eDiary provided to the participant., Other secondary endpoints include the MS Spasticity Scale (MSSS-88), a set of questions asking about spasticity in the participant’s daily life, the Timed 25-Foot Walk (T25FW) test, a test to see how long it takes the participant to walk 25 feet, and the Clinical Global Impression of Severity, a question for the investigator to determine how severe the participant’s condition is.

Countries

Czechia, Germany, Poland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026