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Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients

NCT01968902 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2017-03-22

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

incabotulinumtoxinA

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 at injection visit

BIOLOGICAL

Placebo

Saline injection on the day of injection visit

Sponsors & Collaborators

  • Merz North America, Inc.

    collaborator INDUSTRY

  • Multiple Sclerosis Center of Northeastern New York

    lead OTHER

Principal Investigators

  • Keith R Edwards, MD · MS Center of Northeastern New York

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-01-27
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01968902 on ClinicalTrials.gov