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

Hee, Kyung; Chun, Min Ho; Paik, Nam–Jong; Park, Yoon Ghil; Lee, Shi-Uk; Kim, Don Kyu

doi:10.1177/0269215516689331

Cited by 18 publications

(21 citation statements)

References 13 publications

(34 reference statements)

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“…Another important limitation of this study is the use of only one scale for assessing spasticity. The change in MAS have been used in different studies [40,41]. Although there are certain issues concerning validity and reliability, Ashworth Scales are the most widely used tests to assess the severity of muscle spasticity [42].…”

Section: Discussionmentioning

confidence: 99%

Efficacy of Early Treatment with Onabotulinum Toxin A in Post-Stroke Spasticity

Doce¹

2018

HPMRD

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So far treatment of spasticity is currently delayed until patient develops signs of these complications. Although there is new evidence recommending to start with the treatment within the three months of the stroke onset [22,23], in a classical way, treatment of spasticity was usually delayed until secondary complications are established, approximately 6 months after the stroke [20]. Moreover, it is possible that deterioration in the musculoskeletal impairments before the initiation of spasticity treatment may be detrimental to the patient as these Abstract Background

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Section: Discussionmentioning

confidence: 99%

Efficacy of Early Treatment with Onabotulinum Toxin A in Post-Stroke Spasticity

Doce¹

2018

HPMRD

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“…In another study involving a total of 187 stroke patients with upper limb spasticity, 309.21 6 62.48 U (Botulax) or 312.64 6 49.99 U (Botox) were injected. 55 For wrist flexors, the modified Ashworth scale score decreased 21.45 6 0.61 in the Botulax group and 21.40 6 0.57 in the Botox group.…”

Section: Clinical Use Of Bontmentioning

confidence: 93%

“…There was a significant improvement in Resistance to Passive Movement Scale 4 weeks following each injection, which increased throughout the study as did the proportion of patients achieving ≥3 (of 4) treatment goals. In another study involving a total of 187 stroke patients with upper limb spasticity, 309.21 ± 62.48 U (Botulax) or 312.64 ± 49.99 U (Botox) were injected . For wrist flexors, the modified Ashworth scale score decreased −1.45 ± 0.61 in the Botulax group and −1.40 ± 0.57 in the Botox group.…”

Section: Clinical Use Of Bontmentioning

confidence: 98%

Botulinum toxin: State of the art

2017

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Botulinun neurotoxin (BoNT) has emerged as one of the most multipurpose therapeutic agents in modern medicine with more clinical applications than any other drug currently on the market. Initially developed in the treatment of strabismus and neurologic movement disorders, the use of botulinun neurotoxin has been expanding during the past 3 decades to include the treatment of a variety of ophthalmologic, gastrointestinal, urologic, orthopedic, dermatologic, dental, secretory, painful, cosmetic, and other conditions. In addition to onabotulinumtoxinA (Botox), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), and RimabotulinumtoxinB (Myobloc or NeuroBloc) there are other novel botulinun neurotoxin products currently in development. With a better understanding of the cellular mechanisms of botulinun neurotoxin and advances in biotechnology, future botulinun neurotoxin products will likely be even more effective and customized to the specific indication and tailored to the needs of the patients. © 2017 International Parkinson and Movement Disorder Society.

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“…Letibotulinum toxin A is a novel neurotoxin from the C. botulinum CBFC26 strain that shows high toxicity in mice [ 12 ]. Also, its toxin and 16S rRNA sequences are completely homologous to those of the ATCC 3502 Hall A strain of onabotulinum toxin A. Letibotulinum toxin A has been subjected to additional processes, including enzyme-free purification steps such as protamine sulfate precipitation, to eliminate nucleic acids, and diethylaminoethanol-sepharose chromatography, which could theoretically improve the quality of the product.…”

Section: Introductionmentioning

confidence: 99%

“…Also, its toxin and 16S rRNA sequences are completely homologous to those of the ATCC 3502 Hall A strain of onabotulinum toxin A. Letibotulinum toxin A has been subjected to additional processes, including enzyme-free purification steps such as protamine sulfate precipitation, to eliminate nucleic acids, and diethylaminoethanol-sepharose chromatography, which could theoretically improve the quality of the product. However, few studies have assessed the efficacy and safety of letibotulinum toxin A in the treatment of spasticity [ 12 ]. Also, there has been no report on the effectiveness of letibotulinum toxin A in the management of spasticity in children with CP.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Dynamic Equinus Foot Deformity in Children with Cerebral Palsy: A Randomized Controlled Trial

Chang

Hong

Lee

et al. 2017

Toxins

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The objective of this clinical trial was to compare the efficacy and safety of letibotulinum toxin A and onabotulinum toxin A for improving dynamic equinus foot deformity in children with cerebral palsy (CP). In total, 144 children with spastic CP who had dynamic equinus foot deformity were assigned randomly to the Botulax group (injection of letibotulinum toxin A) or the Botox group (injection of onabotulinum toxin A). The Physician’s Rating Scale (PRS), ankle plantar flexor spasticity using the Modified Tardieu Scale, the Gross Motor Function Measure (GMFM)-88, and the GMFM-66 were completed before injection and at 6, 12, and 24 weeks after injection. The PRS responder rate was 60.27% in the Botulax group and 61.43% in the Botox group at 12 weeks after treatment, and the lower limit of the 95% confidence interval for the between-group difference in responder rates was −17.16%, higher than the non-inferiority margin of −24.00%. The clinical efficacy and the safety profiles of the groups did not significantly differ. The results suggest that injection of letibotulinum toxin A is as effective and safe as that of onabotulinum toxin A for the treatment of dynamic equinus foot deformity in children with spastic CP.

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

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

Cited by 18 publications

References 13 publications

Efficacy of Early Treatment with Onabotulinum Toxin A in Post-Stroke Spasticity

Efficacy of Early Treatment with Onabotulinum Toxin A in Post-Stroke Spasticity

Botulinum toxin: State of the art

Efficacy and Safety of Letibotulinum Toxin A for the Treatment of Dynamic Equinus Foot Deformity in Children with Cerebral Palsy: A Randomized Controlled Trial

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