Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01968902
• Date of registration: 21/10/2013
• Prospective Registration: Yes
• Primary sponsor: Multiple Sclerosis Center of Northeastern New York
• Public title: Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients
• Scientific title: 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
• Date of first enrolment: November 2013
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01968902
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Keith R Edwards, MD
• Affiliation: MS Center of Northeastern New York

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Muscle Spasticity

Multiple Sclerosis

Intervention(s)

Biological: incabotulinumtoxinA

Biological: Placebo

Primary Outcome(s)

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 Outcome(s)

Mean change from injection visit to week 6 in Multiple Sclerosis Impact Scale (MSIS-29) physical and psychological scores between Xeomin vs placebo group [Time Frame: injection visit to week 6]

Change in Patient Global impression of change between Xeomin vs placebo group [Time Frame: change between week 6 and week 12]

Mean change from injection visit to week 6 in Likert Pain Scale between Xeomin vs placebo group [Time Frame: injection visit to week 6]

Clinical Global impression of change between Xeomin vs placebo group [Time Frame: change between week 6 and week 12]

Mean change from injection visit to week 6 in Multiple Sclerosis Walking Scale (MSWS-12) between Xeomin vs placebo group [Time Frame: from injection visit to week 6]

Mean change from injection visit to week 6 in Timed 25 Foot Walk (T25FW) between Xeomin vs placebo group [Time Frame: injection visit to week 6]

Secondary ID(s)

SPASTICITY-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Merz North America, Inc.