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Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial
Botulinum toxin type A injection is widely used treatment option for the treatment of upper limb spasticity in stroke patients. The purpose of this study was to explore the safety and efficacy of MT10107, a new botulinum toxin type A, in patients with post-stroke upper limb spasticity. METHODS: A pr...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Lippincott Williams & Wilkins
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9646656/ https://www.ncbi.nlm.nih.gov/pubmed/36343044 http://dx.doi.org/10.1097/MD.0000000000031367 |
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author | Lee, Junekyung Chun, Min Ho Ko, Young Jin Lee, Shi-Uk Kim, Deog Young Paik, Nam-Jong |
author_facet | Lee, Junekyung Chun, Min Ho Ko, Young Jin Lee, Shi-Uk Kim, Deog Young Paik, Nam-Jong |
author_sort | Lee, Junekyung |
collection | PubMed |
description | Botulinum toxin type A injection is widely used treatment option for the treatment of upper limb spasticity in stroke patients. The purpose of this study was to explore the safety and efficacy of MT10107, a new botulinum toxin type A, in patients with post-stroke upper limb spasticity. METHODS: A prospective, randomized, double-blind, active drug-controlled, multi-center, phase I clinical trial. Thirty patients with post-stroke upper limb spasticity were received either MT10107 or onabotulinumtoxinA. Primary endpoint was change of modified Ashworth scale (MAS) score for wrist flexor from baseline to week 4. The secondary endpoints were changes of MAS scores for elbow and finger flexors, response rate, Disability Assessment Scale (DAS), and global assessment of treatment. The safety endpoints such as adverse events, vital signs, physical examination, and laboratory test were evaluated. The outcome measures were evaluated from baseline to week 4. RESULTS: The primary endpoints were −1.07 ± 0.70 and −1.23 ± 0.56 for the MT10107 and onabotulinumtoxinA groups, respectively. The intergroup difference of change between the 2 groups was 0.17 (95% confidence interval −0.31 to 0.64, P = .5769). In secondary endpoints, both groups showed a significant improvement in both MAS and DAS. There was no significant between-group difference in all secondary endpoints and safety measures. CONCLUSION: The safety and efficacy of MT10107 showed no significant difference compared to onabotulinumtoxinA in post-stroke upper limb spasticity treatment. |
format | Online Article Text |
id | pubmed-9646656 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Lippincott Williams & Wilkins |
record_format | MEDLINE/PubMed |
spelling | pubmed-96466562022-11-14 Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial Lee, Junekyung Chun, Min Ho Ko, Young Jin Lee, Shi-Uk Kim, Deog Young Paik, Nam-Jong Medicine (Baltimore) 6300 Botulinum toxin type A injection is widely used treatment option for the treatment of upper limb spasticity in stroke patients. The purpose of this study was to explore the safety and efficacy of MT10107, a new botulinum toxin type A, in patients with post-stroke upper limb spasticity. METHODS: A prospective, randomized, double-blind, active drug-controlled, multi-center, phase I clinical trial. Thirty patients with post-stroke upper limb spasticity were received either MT10107 or onabotulinumtoxinA. Primary endpoint was change of modified Ashworth scale (MAS) score for wrist flexor from baseline to week 4. The secondary endpoints were changes of MAS scores for elbow and finger flexors, response rate, Disability Assessment Scale (DAS), and global assessment of treatment. The safety endpoints such as adverse events, vital signs, physical examination, and laboratory test were evaluated. The outcome measures were evaluated from baseline to week 4. RESULTS: The primary endpoints were −1.07 ± 0.70 and −1.23 ± 0.56 for the MT10107 and onabotulinumtoxinA groups, respectively. The intergroup difference of change between the 2 groups was 0.17 (95% confidence interval −0.31 to 0.64, P = .5769). In secondary endpoints, both groups showed a significant improvement in both MAS and DAS. There was no significant between-group difference in all secondary endpoints and safety measures. CONCLUSION: The safety and efficacy of MT10107 showed no significant difference compared to onabotulinumtoxinA in post-stroke upper limb spasticity treatment. Lippincott Williams & Wilkins 2022-11-04 /pmc/articles/PMC9646656/ /pubmed/36343044 http://dx.doi.org/10.1097/MD.0000000000031367 Text en Copyright © 2022 the Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial License 4.0 (CCBY-NC) (https://creativecommons.org/licenses/by-nc/4.0/) , where it is permissible to download, share, remix, transform, and buildup the work provided it is properly cited. The work cannot be used commercially without permission from the journal. |
spellingShingle | 6300 Lee, Junekyung Chun, Min Ho Ko, Young Jin Lee, Shi-Uk Kim, Deog Young Paik, Nam-Jong Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial |
title | Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial |
title_full | Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial |
title_fullStr | Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial |
title_full_unstemmed | Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial |
title_short | Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial |
title_sort | safety and efficacy of mt10107 in post-stroke upper limb spasticity treatment: a phase i randomized controlled trial |
topic | 6300 |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9646656/ https://www.ncbi.nlm.nih.gov/pubmed/36343044 http://dx.doi.org/10.1097/MD.0000000000031367 |
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