This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral arbaclofen ER tablets in MS patients with spasticity. Arbaclofen ER will be compared with placebo.
Subjects 18 to 65 years of age, inclusive
An established diagnosis per McDonald Criteria (Polman et al 2011) of MS (either RR or SP course) that manifests a documented history of spasticity for at least 6 months prior to screening
Spasticity due to MS as shown by a TNmAS-MAL score ≥ 2
Expanded Disability Status Scale (EDSS) score greater than or equal to (≥) 3.0 and less than or equal to (≤) 7.0
Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
In the opinion of the investigator, the patient is unable to rate their level of spasticity or distinguish it from other MS symptoms
Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
Pregnancy, lactation, or planned pregnancy during the course of the study and for 3 months after the final study visit
Parallel
Arbaclofen
DrugArbaclofen Extended Release Tablets
Placebo
DrugPlacebo tablets
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Most Affected Limb (TNmAS-MAL)
The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The limb with the highest score is the most affected limb. Lower score is better. Scale is from 0 to 5.
Responder Analysis of Ashworth Scale Score (AS-MAL-R) for Maintenance Treatment Period
Responder status (AS-MAL-R) consists of three response categorical outcomes based on the Ashworth Scale (AS). Where the possible outcomes are: Strong Responder, Responder, or Non-Responder
Change from Baseline to Maintenance Treatment Period for Total Numeric-Transformed Modified Ashworth Scale Total Limbs (TNmAS-TL)
The total numerical score of a limb accounts for the sum of the 3 main joint muscular group scores. The total of the 4 limbs is the total limbs score. Lower score is better. Scale is from 0 to 5 per joint, Maximum score per limb is 15. Maximum total limbs score is 60.
Clinician's global impression of change (CGIC) for Maintenance Treatment Period
The clinician makes a judgment about the change from baseline of illness severity, the subject's level of distress, other aspects of impairment, and the impact of the illness on functioning. Scale of -3 to +3, higher score is better
Numeric Rating Scale of Spasticity (NRS-S) for Maintenance Treatment Period
The Numeric Rating Scale of Spasticity is a patient rated measure of the perceived severity of spasticity using a 0-10 numeric rating scale. Lower score is better.
Expanded Disability Status Scale (EDSS) for Maintenance Treatment Period
EDSS is a method of quantifying disability in MS and monitoring changes in the level of disability over time. Scale ranges from 0-10, in 0.5 unit increments. Lower score is better.
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