Trial record 2 of 68 for:    Open Studies | "Muscle Spasticity"

Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Multiple Sclerosis Center of Northeastern New York
Sponsor:
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Multiple Sclerosis Center of Northeastern New York
ClinicalTrials.gov Identifier:
NCT01968902
First received: October 21, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Muscle Spasticity
Multiple Sclerosis
Biological: incabotulinumtoxinA
Biological: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Multiple Sclerosis Center of Northeastern New York:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Change in Patient Global impression of change between Xeomin vs placebo group [ Time Frame: change between week 6 and week 12 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Clinical Global impression of change between Xeomin vs placebo group [ Time Frame: change between week 6 and week 12 ] [ Designated as safety issue: No ]
  • Mean change from injection visit to week 6 in Likert Pain Scale between Xeomin vs placebo group [ Time Frame: injection visit to week 6 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: incabotulinumtoxinA
intramuscular injection, 200 to 400 units, 1 injection visit only
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
Other Name: Xeomin®
Placebo Comparator: Placebo
intramuscular injection, saline 200 - 400 units , 1 injection visit only
Biological: Placebo
Saline injection on the day of injection visit

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968902

Contacts
Contact: Keith R Edwards, MD 518-785-1000 kedwards@tristateneuro.com

Locations
United States, New York
Multiple Sclerosis Center of Northeastern New York Recruiting
Latham, New York, United States, 12110
Contact: Judy Button    518-785-1000    jbutton@tristateneuro.com   
Principal Investigator: Keith R Edwards, MD         
Sponsors and Collaborators
Multiple Sclerosis Center of Northeastern New York
Merz Pharmaceuticals, LLC
Investigators
Principal Investigator: Keith R Edwards, MD MS Center of Northeastern New York
  More Information

Publications:

Responsible Party: Multiple Sclerosis Center of Northeastern New York
ClinicalTrials.gov Identifier: NCT01968902     History of Changes
Other Study ID Numbers: SPASTICITY-001
Study First Received: October 21, 2013
Last Updated: January 16, 2014
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Multiple Sclerosis Center of Northeastern New York:
spasticity
lower limb
multiple sclerosis
toxin

Additional relevant MeSH terms:
Muscle Spasticity
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014