A Study to Investigate the Safety and Effectiveness of Arbaclofen Extended-Release Tablets for Patients With MS
Condition: Multiple Sclerosis; Spasticity, Muscle
MeSH terms: Muscle Spasticity; Multiple Sclerosis; Sclerosis
Intervention: Arbaclofen; Placebo
Intervention description: Arbaclofen Extended Release Tablet; Placebo comparator
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 536.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Multiple Sclerosis (MS) is an acquired inflammatory demyelinating disease of the central
      nervous system (CNS) that is regarded as the foremost cause of non-traumatic neurologic
      disability in adults in North America. Spasticity is a common complication in MS and occurs
      in up to 84% of patients. The main sign of spasticity is resistance to passive limb movement
      characterized by increased resistance to stretching, clonus, and exaggerated deep reflexes.
      Osmotica Pharmaceutical is currently developing arbaclofen extended-release tablets (AERT)
      for the treatment of spasticity in patients with MS.
    

Eligibility criteria:

        Inclusion Criteria Includes:

          -  Subjects 18 to 65 years of age, inclusive.

          -  An established diagnosis of MS that manifests a documented history of spasticity.

          -  If receiving disease-modifying medications (eg, interferons approved for MS,
             glatiramer acetate, natalizumab, fingolimod, or mitoxantrone), there must be no change
             in dose for at least 3 months prior to Visit 1 (Screening), and the subject must be
             willing to maintain this treatment dose for the duration of the study. If receiving
             AMPYRA® (dalfampridine, fampridine, 4-amino puridine), subject must be at a stable
             dose for at least 3 months prior to Visit 1.

          -  Stable regimen for at least 3 months prior to Visit 2 for all medications and
             non-pharmacological therapies that are intended to alleviate spasticity.

          -  Absence of infections, peripheral vascular disease, painful contractures, advanced
             arthritis, or other conditions that hinder evaluation of joint movement.

          -  Use of a medically highly effective form of birth control (see Section 7.8) during the
             study and for 3 months thereafter for women of child-bearing potential (including
             female subjects and female partners of non-sterile male subjects).

          -  Willing to sign the informed consent form (ICF).

        Exclusion Criteria Includes:

          -  Any concomitant disease or disorder that has symptoms of spasticity or that may
             influence the subject's level of spasticity.

          -  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.

          -  Subject has clinically significant abnormal laboratory values, in the opinion of the
             investigator, at Visit 1 or Visit 2.

          -  Current malignancy or history of malignancy that has not been in remission for more
             than 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, puts the subject at risk because of participation,
             influences the result of the study, or affects the subject's ability to participate.