A Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Incobotulinumtoxin Type A for the Functional Improvement of Lower Extremity Spasticity in Patients With Multiple Sclerosis
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Enrollment
- 27
- Locations
- 2
- Primary Endpoint
- Mean change from injection visit to week 6 in the Modified Ashworth score between Xeomin vs placebo group
Study Overview
Brief Summary
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.
Detailed Description
Overall Design: Thirty patients with MS, male or female, ages 18-70, either relapsing or progressive types, are to be evaluated in a prospective treatment trial comparing gait before and after injections of Xeomin.
Patient Population: The patients included are to have functionally significant equinovarus spasticity in primarily one lower extremity; functionally significant spasticity is defined as spasticity impairing gait during observation of during a 25 foot walk, causing falls, or leading to secondary orthopedic complications such as genu recurvatum or pain in the low back or hip. The patients are to be ambulatory, with stable disease.
Dose Selection: A dose of 200 units to 400 units of Xeomin will be injected by EMG-guided technique into the appropriate muscles in the effected leg. These muscles may include gastrocnemius and soleus, tibialis posterior or other muscles as determined by the examiner. The dose administered will be determined by the blinded injector based on determination of muscle bulk and the degree of spasticity Blinding: Investigators will be blinded to medication used throughout study. Site will randomize subjects in a 1:1 fashion by using an unblinded site delegate.
Compliance with Laws and Regulations: This study will be conducted in accordance with the U.S. Food and Drug Administration (FDA) regulations, the International Conference on Harmonisation (ICH) E6 Guideline for Good Clinical Practice (GCP), and applicable local, state, and federal laws.
Study Assessments: After informed consent is obtained and screening measurements are completed, the patients will return at 4 weeks for injection for primary and secondary efficacy evaluations. Additional evaluations at 6 and 12 weeks will be made in order to determine the duration of effect of Xeomin for secondary efficacy evaluations.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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.
Outcomes
Primary Outcomes
Mean change from injection visit to week 6 in the Modified Ashworth score between Xeomin vs placebo group
Time Frame: injection visit to week 6
Secondary Outcomes
- Mean change from injection visit to week 6 in Multiple Sclerosis Walking Scale (MSWS-12) between Xeomin vs placebo group(from injection visit to week 6)
- Change in Patient Global impression of change between Xeomin vs placebo group(change between week 6 and week 12)
- Mean change from injection visit to week 6 in Multiple Sclerosis Impact Scale (MSIS-29) physical and psychological scores between Xeomin vs placebo group(injection visit to week 6)
- Mean change from injection visit to week 6 in Timed 25 Foot Walk (T25FW) between Xeomin vs placebo group(injection visit to week 6)
- Clinical Global impression of change between Xeomin vs placebo group(change between week 6 and week 12)
- Mean change from injection visit to week 6 in Likert Pain Scale between Xeomin vs placebo group(injection visit to week 6)