Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul.
Arch Phys Med Rehabil. 2020 Sep;101(9):1485-1496. doi: 10.1016/j.apmr.2020.03.025. Epub 2020 Jun 1.
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.
Seven university hospitals in the Republic of Korea.
Patients (N=220) with poststroke upper limb spasticity.
All participants received a single injection of either MT10107 (Coretox group) or onabotulinum toxin A (Botox group).
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.
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.
MT10107 showed no significant difference in efficacy and safety compared with onabotulinum toxin A in poststroke upper limb spasticity treatment.
比较 MT10107（Coretox）与肉毒毒素 A（Botox）治疗脑卒中后上肢痉挛的疗效和安全性。
前瞻性、随机、双盲、阳性药物对照、多中心、Ⅲ期临床试验。
韩国 7 所大学医院。
脑卒中后上肢痉挛患者（N=220）。
所有患者均接受单次 MT10107（Coretox 组）或肉毒毒素 A（Botox 组）注射。
主要结局指标为从基线到第 4 周时腕屈肌痉挛的变化，采用改良 Ashworth 量表（MAS）评估。次要结局指标为腕、肘和指屈肌的 MAS 评分、治疗应答率（应答率）、残疾评估量表（DAS）评分和治疗整体评价。根据不良反应、生命体征、体格检查结果和实验室检查结果评估安全性。在干预后 4、8 和 12 周评估疗效和安全性。
Coretox 组和 Botox 组的主要结局分别为-1.32±0.69 和-1.40±0.69。MT10107 与肉毒毒素 A 的疗效相当，组间差异的 95%置信区间为-0.10 至 0.27，上限小于非劣效性边界 0.45。对于次要结局，两组所有肌肉的 MAS 评分和 DAS 评分在所有时间点均有显著改善，组间无显著差异。在应答率、治疗整体评价和安全性措施方面，两组间也无显著差异。
MT10107 治疗脑卒中后上肢痉挛的疗效和安全性与肉毒毒素 A 无显著差异。
