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Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial

 Junekyung Lee  ;  Min Ho Chun  ;  Young Jin Ko  ;  Shi-Uk Lee  ;  Deog Young Kim  ;  Nam-Jong Paik 
 MEDICINE, Vol.101(44) : e31367, 2022-11 
Journal Title
Issue Date
Botulinum Toxins, Type A* / therapeutic use ; Double-Blind Method ; Humans ; Muscle Spasticity / drug therapy ; Muscle Spasticity / etiology ; Neuromuscular Agents* / therapeutic use ; Prospective Studies ; Stroke* / complications ; Stroke* / drug therapy ; Treatment Outcome ; Upper Extremity
Background: 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.
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1. College of Medicine (의과대학) > Dept. of Rehabilitation Medicine (재활의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Deog Young(김덕용) ORCID logo https://orcid.org/0000-0001-7622-6311
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