Safety of Xeomin for Lower Limb Spasticity in Multiple Sclerosis Patients

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.

Timeline

Start

2013-11

Primary completion

2016-01-27

Completion

2016-12-31

Publications

• Background 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.

Drugs

Indications