[Abstract+References] Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity: a randomized, double blind, multi-center, phase III clinical trial

To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax®) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox®).

A prospective, double-blinded, multicenter, randomized controlled clinical study.

Six university hospitals in Korea.

A total of 187 stroke participants with upper limb spasticity.

Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)(P>0.05).

Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored.

The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93(P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95% CI:-0.23–0.12,P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale (P<0.05), and no significant difference was observed between the two groups (P>0.05). In addition, safety measures showed no significant differences between the two groups (P>0.05).

The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.

 

1. Kanovsky P, Slawek J, Denes Z, . Efficacy and safety of botulinum neurotoxin NT 201 in poststroke upper limb spasticity. Clin Neuropharmacol 2009; 32: 259265. Google Scholar CrossRef, Medline
2. Slawek J, Bogucki A, Reclawowicz D. Botulinum toxin type A for upper limb spasticity following stroke: an open-label study with individualised, flexible injection regimens. Neurol Sci 2005; 26: 3239. Google Scholar CrossRef, Medline
3. Jost WH, Hefter H, Reissig A, . Efficacy and safety of botulinum toxin type A (Dysport) for the treatment of post-stroke arm spasticity: results of the German-Austrian open-label post-marketing surveillance prospective study. J Neurol Sci 2014; 337: 8690. Google Scholar CrossRef, Medline
4. Simpson DM, Alexander DN, O’Brien CF, . Botulinum toxin type A in the treatment of upper extremity spasticity: a randomized, double-blind, placebo-controlled trial. Neurology 1996; 46: 13061310. Google Scholar CrossRef, Medline
5. Brashear A, Gordon MF, Elovic E, . Intramuscular injection of botulinum toxin for the treatment of wrist and finger spasticity after a stroke. N Engl J Med 2002; 347: 395400. Google Scholar CrossRef, Medline
6. Shaw LC, Price CI, van Wijck FM, . Botulinum toxin for the upper limb after stroke (BoTULS) trial: effect on impairment, activity limitation, and pain. Stroke 2011; 42: 13711379. Google Scholar CrossRef, Medline
7. Childers MK, Brashear A, Jozefczyk P, . Dose-dependent response to intramuscular botulinum toxin type A for upper-limb spasticity in patients after a stroke. Arch Phys Med Rehabil 2004; 85: 10631069. Google Scholar CrossRef, Medline
8. Simpson DM, Gracies JM, Yablon SA, . Botulinum neurotoxin versus tizanidine in upper limb spasticity: a placebo-controlled study. J Neurol Neurosurg Psychiatry 2009; 80: 380385. Google Scholar CrossRef, Medline
9. Seo HG, Paik NJ, Lee SU, . Neuronox versus BOTOX in the Treatment of Post-Stroke Upper Limb Spasticity: A Multicenter Randomized Controlled Trial. PLoS One 2015; 10: e0128633. Google Scholar CrossRef
10. Bohannon RW, Smith MB. Interrater reliability of a modified Ashworth scale of muscle spasticity. Phys Ther 1987; 67: 206207. Google Scholar Medline
11. Brashear A, Zafonte R, Corcoran M, . Inter- and intrarater reliability of the Ashworth Scale and the Disability Assessment Scale in patients with upper-limb poststroke spasticity. Arch Phys Med Rehabil 2002; 83: 13491354. Google Scholar CrossRef, Medline
12. Wang HC, Hsieh LF, Chi WC, . Effect of intramuscular botulinum toxin injection on upper limb spasticity in stroke patients. Am J Phys Med Rehabil 2002; 81: 272278. Google Scholar CrossRef, Medline
13. Bhakta BB, Cozens JA, Chamberlain MA, . Impact of botulinum toxin type A on disability and carer burden due to arm spasticity after stroke: a randomised double blind placebo controlled trial. J Neurol Neurosurg Psychiatry 2000; 69: 217221. Google Scholar CrossRef, Medline

Source: Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity: a randomized, double blind, multi-center, phase III clinical trial – Jan 25, 2017

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