Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis

Inclusion Criteria:

• Patients (male or female) 18 to 65 years of age, inclusive, at the time of dosing
• Have an established diagnosis (per McDonald Criteria) of Multiple Sclerosis (eitherrelapsing remitting or secondary progressive course), that manifests spasticity for atleast 6 months
• Spasticity due to MS as shown by a TNmAS score equal or greater than six (≥6) in themost affected limb.
• EDSS equal or greater than 3.0
• If receiving disease-modifying medications, these must have been at a stable dose forat least three (3) months prior to screening, and the subject must be willing tomaintain this treatment for the duration of the study
• Stable regimen for at least thirty (30) days prior to study entry for all medicationsand non-pharmacological therapies that are intended to alleviate spasticity
• Absence of infections, peripheral vascular disease, painful contractures, advancedarthritis, or other conditions that hinder evaluation of joint movement
• Have a creatinine clearance, as calculated by Glomerular Filtration Rate using theModification of Diet in Renal Disease (MDRD) Study equation, greater than 60mL/min.
• Use of a medically highly effective of birth control during the study and for ninety (90) days thereafter for women of child-bearing potential (including female subjectsand female partners of non-sterile male subjects)
• Willing to allow his or her general practitioner and consultant, if appropriate, to benotified of participation in the study

Exclusion Criteria:

• Any concomitant disease or disorder that has symptoms of spasticity or that mayinfluence 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 ofthe 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 referenceformulation
• 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 significantmedical 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 oruntreated depression
• Subjects with abnormal micturition that requires indwelling or intermittentcatheterization or with lower urinary tract symptoms (LUTS) that result in a scoregreater than twenty-six (>26) in the Baseline USP© questionnaire
• Current malignancy or history of malignancy that has not been in remission for morethan five (5) years, except effectively treated basal cell skin carcinoma
• Any other significant disease, disorder or significant laboratory finding which, inthe 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 thestudy
• Subject who is inappropriate for placebo medication in the judgment of theInvestigator
• History of substance abuse within the past twelve (12) months
• Current chronic use of long acting opioids or round the clock use of short actingopioids 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