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Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01968902
First Posted: October 24, 2013
Last Update Posted: March 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merz Pharmaceuticals, LLC
Information provided by (Responsible Party):
Multiple Sclerosis Center of Northeastern New York
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

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

Enrollment: 27
Study Start Date: November 2013
Study Completion Date: December 31, 2016
Primary Completion Date: January 27, 2016 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968902


Locations
United States, New York
Multiple Sclerosis Center of Northeastern New York
Latham, New York, United States, 12110
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:
Hesse S, Lücke D, Malezic M, Bertelt C, Friedrich H, Gregoric M, Mauritz KH. Botulinum toxin treatment for lower limb extensor spasticity in chronic hemiparetic patients. J Neurol Neurosurg Psychiatry. 1994 Nov;57(11):1321-4.
Gilmartin R, Bruce D, Storrs BB, Abbott R, Krach L, Ward J, Bloom K, Brooks WH, Johnson DL, Madsen JR, McLaughlin JF, Nadell J. Intrathecal baclofen for management of spastic cerebral palsy: multicenter trial. J Child Neurol. 2000 Feb;15(2):71-7.
Levin AB, Sperling KB. Complications associated with infusion pumps implanted for spasticity. Stereotact Funct Neurosurg. 1995;65(1-4):147-51.
Loubser PG, Narayan RK, Sandin KJ, Donovan WH, Russell KD. Continuous infusion of intrathecal baclofen: long-term effects on spasticity in spinal cord injury. Paraplegia. 1991 Jan;29(1):48-64.
de Paiva A, Meunier FA, Molgó J, Aoki KR, Dolly JO. Functional repair of motor endplates after botulinum neurotoxin type A poisoning: biphasic switch of synaptic activity between nerve sprouts and their parent terminals. Proc Natl Acad Sci U S A. 1999 Mar 16;96(6):3200-5.
Koman LA, Mooney JF 3rd, Smith BP, Walker F, Leon JM. Botulinum toxin type A neuromuscular blockade in the treatment of lower extremity spasticity in cerebral palsy: a randomized, double-blind, placebo-controlled trial. BOTOX Study Group. J Pediatr Orthop. 2000 Jan-Feb;20(1):108-15.
Brashear A, Gordon MF, Elovic E, Kassicieh VD, Marciniak C, Do M, Lee CH, Jenkins S, Turkel C; Botox Post-Stroke Spasticity Study Group. Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med. 2002 Aug 8;347(6):395-400.
Dykstra DD, Sidi AA. Treatment of detrusor-sphincter dyssynergia with botulinum A toxin: a double-blind study. Arch Phys Med Rehabil. 1990 Jan;71(1):24-6.
Yablon SA, Agana BT, Ivanhoe CB, Boake C. Botulinum toxin in severe upper extremity spasticity among patients with traumatic brain injury: an open-labeled trial. Neurology. 1996 Oct;47(4):939-44.
Snow BJ, Tsui JK, Bhatt MH, Varelas M, Hashimoto SA, Calne DB. Treatment of spasticity with botulinum toxin: a double-blind study. Ann Neurol. 1990 Oct;28(4):512-5.
Hyman N, Barnes M, Bhakta B, Cozens A, Bakheit M, Kreczy-Kleedorfer B, Poewe W, Wissel J, Bain P, Glickman S, Sayer A, Richardson A, Dott C. Botulinum toxin (Dysport) treatment of hip adductor spasticity in multiple sclerosis: a prospective, randomised, double blind, placebo controlled, dose ranging study. J Neurol Neurosurg Psychiatry. 2000 Jun;68(6):707-12.
Borg-Stein J, Pine ZM, Miller JR, Brin MF. Botulinum toxin for the treatment of spasticity in multiple sclerosis. New observations. Am J Phys Med Rehabil. 1993 Dec;72(6):364-8.
Pierson SH, Katz DI, Tarsy D. Botulinum toxin A in the treatment of spasticity: functional implications and patient selection. Arch Phys Med Rehabil. 1996 Jul;77(7):717-21.
Hobart JC, Riazi A, Lamping DL, Fitzpatrick R, Thompson AJ. Measuring the impact of MS on walking ability: the 12-Item MS Walking Scale (MSWS-12). Neurology. 2003 Jan 14;60(1):31-6.
Moore AP. Botulinum toxin A (BoNT-A) for spasticity in adults. What is the evidence? Eur J Neurol. 2002 May;9 Suppl 1:42-7; dicussion 53-61. Review.

Responsible Party: Multiple Sclerosis Center of Northeastern New York
ClinicalTrials.gov Identifier: NCT01968902     History of Changes
Other Study ID Numbers: SPASTICITY-001
First Submitted: October 21, 2013
First Posted: October 24, 2013
Last Update Posted: March 22, 2017
Last Verified: March 2017

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

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Muscle Spasticity
Pathologic Processes
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
incobotulinumtoxinA
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents


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