Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients

Treatment tested

• incabotulinumtoxinA

Placebo or sham

• Placebo

Other measures (6)

Inclusion Criteria: * Male or female patients with clinically definite MS, either RRMS or a progressive form (SPMS, PPSM, PRMS) * Ages 18-65 years. * Patients must be in a stable state, with no clinical relapses or methylprednisolone treatments in the last 30 days, or have slowly progressive MS, with an EDSS score of 2.0-6.5. * Patients must have functionally significant spasticity in predominantly one lower extremity as determined by a score of >2 on the Modified Ashworth Scale at screen Exclusion Criteria: * Unstable medical or neurological disease * Known sensitivity to Xeomin * Prior injection with any botulinum toxin within 6 months * EDSS score of 7.0 or greater * Exacerbation of MS within the past 30 days * Significant cognitive impairment or psychiatric disease * Advanced arthritis or any other cause of clinically significant limitation of passive range of motion around any of the joints being assessed in the study. * Concomitant neurologic conditions causing spasticity or rigidity. * Has had major surgery within 3 months prior to Screening visit that may affect spasticity assessments such as back, lower leg or knee surgeries. * Use of medications that could influence muscle tone or any anti-spasticity medications must be stable >90 days prior to screening visit and must remain stable throughout study period.

The purpose of this study is to determine if Xeomin® will prove effective for significantly improving lower extremity spasticity and will be well tolerated by the majority of MS patients.