Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients

NCT01968902 | Completed Phase 4

• 1 other identifier: SPASTICITY-001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Spasticity; Multiple Sclerosis

Keywords

spasticity; lower limb; multiple sclerosis; toxin

Outcome Measures

Primary Outcomes (1)

• Mean change from injection visit to week 6 in the Modified Ashworth score between Xeomin vs placebo group

  injection visit to week 6

Secondary Outcomes (6)

• 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

Study Arms (2)

incabotulinumtoxinA

ACTIVE COMPARATOR

intramuscular injection, 200 to 400 units, 1 injection visit only

Biological: incabotulinumtoxinA

Placebo

PLACEBO COMPARATOR

intramuscular injection, saline 200 - 400 units , 1 injection visit only

Biological: Placebo

Interventions

incabotulinumtoxinA BIOLOGICAL

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

Also known as: Xeomin®

incabotulinumtoxinA

Placebo BIOLOGICAL

Saline injection on the day of injection visit

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Multiple Sclerosis Center of Northeastern New York: lead
• Merz North America, Inc.: collaborator

Study Sites (1)

Multiple Sclerosis Center of Northeastern New York

Latham, New York, 12110, United States

Location

Related Publications (15)

• 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. doi: 10.1046/j.1468-1331.2002.0090s1042.x.

  PMID: 11918649 BACKGROUND

• Hesse S, Lucke 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. doi: 10.1136/jnnp.57.11.1321.

  PMID: 7964805 RESULT

• 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. doi: 10.1177/088307380001500201.

  PMID: 10695888 RESULT

• Levin AB, Sperling KB. Complications associated with infusion pumps implanted for spasticity. Stereotact Funct Neurosurg. 1995;65(1-4):147-51. doi: 10.1159/000098887.

  PMID: 8916345 RESULT

• 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. doi: 10.1038/sc.1991.7.

  PMID: 2023770 RESULT

• de Paiva A, Meunier FA, Molgo 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. doi: 10.1073/pnas.96.6.3200.

  PMID: 10077661 RESULT

• 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.

  PMID: 10641699 RESULT

• 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. doi: 10.1056/NEJMoa011892.

  PMID: 12167681 RESULT

• 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.

  PMID: 2297305 RESULT

• 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. doi: 10.1212/wnl.47.4.939.

  PMID: 8857723 RESULT

• 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. doi: 10.1002/ana.410280407.

  PMID: 2252363 RESULT

• 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. doi: 10.1136/jnnp.68.6.707.

  PMID: 10811692 RESULT

• 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.

  PMID: 8260129 RESULT

• 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. doi: 10.1016/s0003-9993(96)90015-5.

  PMID: 8670002 RESULT

• 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. doi: 10.1212/wnl.60.1.31.

  PMID: 12525714 RESULT

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis

Interventions

incobotulinumtoxinA

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Keith R Edwards, MD

  MS Center of Northeastern New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2013
• First Posted: October 24, 2013
• Study Start: November 1, 2013
• Primary Completion: January 27, 2016
• Study Completion: December 31, 2016
• Last Updated: March 22, 2017

Record last verified: 2017-03

Locations

US (1)