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A Randomized, Double-Blind, Active Control, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Liztox® versus Botox® in Post-Stroke Upper Limb Spasticity

Authors
 Dong Hyun Ye  ;  Min Ho Chun  ;  Yoon Ghil Park  ;  Nam-Jong Paik  ;  Shi-Uk Lee  ;  Seung Don Yoo  ;  Deog Young Kim 
Citation
 TOXINS, Vol.15(12) : 697, 2023-12 
Journal Title
TOXINS
Issue Date
2023-12
MeSH
Botulinum Toxins, Type A* / adverse effects ; Double-Blind Method ; Humans ; Immunoglobulin A ; Muscle Spasticity / drug therapy ; Muscle Spasticity / etiology ; Neuromuscular Agents* / adverse effects ; Stroke* / complications ; Stroke* / drug therapy ; Treatment Outcome ; Upper Extremity
Keywords
botulinum toxin ; spasticity ; stroke ; upper extremity
Abstract
Botulinum toxin type A (BTX-A) injection is a commonly used therapeutic intervention for upper limb spasticity in stroke patients. This study was designed as a randomized, active-drug-controlled, double-blind, multicenter, phase 3 clinical trial to evaluate the safety and efficacy of Liztox® in comparison to onabotulinum toxin A (Botox®) for individuals with post-stroke upper limb spasticity. The primary outcome was the alteration in wrist flexor muscle tone from the initial assessment to the fourth week, evaluated using the modified Ashworth scale (MAS). Secondary outcomes included MAS score changes for the wrist at weeks 8 and 12 from baseline; MAS score changes for finger and elbow flexors; and changes in the Disability Assessment Scale (DAS), Subject’s Global Assessment (SGA), the Investigator’s Global Assessment (IGA), and Caregiver Burden Scale (CBS) at weeks 4, 8, and 12 from baseline. The MAS score for wrist flexor spasticity decreased by −1.14 ± 0.59 in the Liztox® group and −1.22 ± 0.59 in the Botox® group from baseline to week 4. The difference [97.5% confidence interval (CI)] between the test and control groups was 0.08 [−∞, 0.26], confirming the non-inferiority of the test group compared to the control group. Furthermore, there were consistent improvements in the IGA, SGA, and CBS scores across all assessment intervals, with no statistically significant variances detected between the two groups. No safety-related concerns were reported during the study. In conclusion, Liztox® injection proved to be a secure and efficacious intervention for managing upper extremity spasticity in post-stroke patients.
Files in This Item:
T202400450.pdf Download
DOI
10.3390/toxins15120697
Appears in Collections:
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
Park, Yoon Ghil(박윤길) ORCID logo https://orcid.org/0000-0001-9054-5300
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/197915
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