Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

Exclusion Criteria

• •Any concomitant disease or disorder that has symptoms of spasticity or that may influence the subject's level of spasticity
• •Inability to rate their level of spasticity or distinguish it from other MS symptoms
• •Acute MS exacerbation requiring treatment within twelve (12) weeks of screening
• •Use of intravenous methylprednisolone within the twelve (12) weeks before visit 1
• •Concomitant use of medications that would potentially interfere with the actions of the study medication or outcome variables
• •Use of botulinum toxin A or B within six (6) months of visit 1
• •History of allergy to baclofen or any inactive component of test or reference formulation
• •Pregnancy, lactation or planned pregnancy during the course of the study and for three (3) months thereafter.
• •History of unstable psychiatric disease, or current signs and symptoms of significant medical disorders such as severe, progressive, or uncontrolled pulmonary, cardiac, gastrointestinal, hepatic, renal, genitourinary, hematological, endocrine, immunologic, or neurological disease
• •History of seizures
• •Current significant cognitive deficit, severe or untreated anxiety, severe or untreated depression
• •Subjects with abnormal micturition that requires indwelling or intermittent catheterization or with lower urinary tract symptoms (LUTS) that result in a score greater than twenty-six (\>26) in the Baseline USP© questionnaire
• •Current malignancy or history of malignancy that has not been in remission for more than five (5) years, except effectively treated basal cell skin carcinoma
• •Any other significant disease, disorder or significant laboratory finding which, in the opinion of the investigator, put the subject at risk because of participation, influence the result of the study, or affect the subject's ability to participate
• •Planned elective surgery or other procedures requiring general anesthesia during the study
• •Subject who is inappropriate for placebo medication in the judgment of the Investigator
• •History of substance abuse within the past twelve (12) months
• •Current chronic use of long acting opioids or round the clock use of short acting opioids for the treatment of pain
• •Participation in another research study within thirty (30) days of Screening
• •Patients who are uncooperative or unwilling to sign consent form