Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients
Completed · Phase 4 · Has a placebo group
Conditions studied: Muscle Spasticity, Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT01968902
- Run by
- Multiple Sclerosis Center of Northeastern New York
- People needed
- 27
- Starts
- 2013-11-01
- Expected to finish
- 2016-12-31
- Last updated by the study team
- 2017-03-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Multiple Sclerosis Center of Northeastern New York — Latham, New York, United States
Full record on ClinicalTrials.gov
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