Efficacy and Safety of Arbaclofen Placarbil in Subjects With Spasticity Due to Multiple Sclerosis

Exclusion criteria

• ✕. Maximum Ashworth Score Scale score of ≥ 2 in at least one of the following muscle groups on either side of the body: hip abductors/adductors, knee flexors/extensors, ankle flexors/extensors.
• ✕. Expanded Disability Status Scale (EDSS) rating between 3.0-8.0 inclusive.
• ✕. If a subject is on disease modifying MS treatment, the dosage, frequency, and route of administration must be stable for at least 30 days before screening and is expected to be stable throughout the study.
• ✕. Spasticity Disability Rating of 2 or higher at Baseline.
• ✕. Willing to discontinue and refrain from using for the duration of the study drugs for the treatment of spasticity or likely to affect spasticity (including, but not limited to, baclofen, tizanidine, diazepam, clonazepam, metaxalone, dantrolene, cyclobenzaprine, carisoprodol, clonidine, vigabatrin, valproic acid and cannabis).
• ✕. Spasticity due to neurological disorder other than MS or other conditions that may confound the assessment of spasticity.
• ✕. Subject has clinically evident muscle contractures resulting in irreversible spasticity in lower extremities.
• ✕. Subjects who have suffered an acute relapse of MS (as determined by the Investigator) within 90 days prior to Screening, or have had more than 1 relapse within the year prior to Screening