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Efficacy and Safety of MT10107 (Coretox) in Poststroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multicenter, Phase III Clinical Trial

Authors
 Junekyung Lee  ;  Min Ho Chun  ;  Young Jin Ko  ;  Shi-Uk Lee  ;  Deog Young Kim  ;  Nam-Jong Paik  ;  Bum Sun Kwon  ;  Yoon Ghil Park 
Citation
 ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION, Vol.101(9) : 1485-1496, 2020-09 
Journal Title
 ARCHIVES OF PHYSICAL MEDICINE AND REHABILITATION 
ISSN
 0003-9993 
Issue Date
2020-09
MeSH
Aged ; Botulinum Toxins, Type A / adverse effects ; Botulinum Toxins, Type A / therapeutic use* ; Disability Evaluation ; Double-Blind Method ; Female ; Humans ; Male ; Middle Aged ; Muscle Spasticity / drug therapy* ; Muscle Spasticity / etiology* ; Neuromuscular Agents / adverse effects ; Neuromuscular Agents / therapeutic use* ; Prospective Studies ; Republic of Korea ; Stroke / complications* ; Stroke Rehabilitation / methods ; Upper Extremity
Keywords
Botulinum toxins ; Muscle spasticity ; Rehabilitation ; Safety ; Stroke ; Upper extremity
Abstract
Objective: To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity DESIGN: Prospective, randomized, double-blind, active drug-controlled, multicenter, phase III clinical trial. Setting: Seven university hospitals in the Republic of Korea. Participants: Patients (N=220) with poststroke upper limb spasticity. Interventions: All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group). Main outcome measures: The primary outcome was change in wrist flexor spasticity from baseline to week 4, which was assessed using the modified Ashworth scale (MAS). The secondary outcomes were MAS scores for wrist, elbow, and finger flexors; percentage of treatment responders (response rate); Disability Assessment Scale (DAS) score, and global assessment of treatment. Safety was evaluated based on adverse events, vital signs, physical examination findings, and laboratory test results. The efficacy and safety were evaluated at 4, 8, and 12 weeks postintervention. Results: The primary outcome was found to be -1.32±0.69 and -1.40±0.69 for the Coretox and Botox groups, respectively. MT10107 showed a non-inferior efficacy compared with onabotulinum toxin A, as the 95% confidence interval for between-group differences was -0.10 to 0.27 and the upper limit was less than the non-inferiority margin of 0.45. Regarding the secondary outcomes, MAS scores for all muscles and DAS scores showed a significant improvement at all time points in both groups, with no significant between-group difference. No significant between-group differences were observed regarding response rate, global assessment of treatment, and safety measures. Conclusions: MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.
Full Text
https://www.sciencedirect.com/science/article/pii/S0003999320303099
DOI
10.1016/j.apmr.2020.03.025
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/22282913/180461
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