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