Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT01968902
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01968902
Study Brief:
Protocol Section:
NCT01968902