Department of Rehabilitation Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Republic of Korea.
Department of Rehabilitation Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Medicine (Baltimore). 2022 Nov 4;101(44):e31367. doi: 10.1097/MD.0000000000031367.
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.
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.
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.
The safety and efficacy of MT10107 showed no significant difference compared to onabotulinumtoxinA in post-stroke upper limb spasticity treatment.
肉毒毒素 A 注射是治疗脑卒中患者上肢痉挛的常用治疗方法。本研究旨在探讨新型肉毒毒素 MT10107 治疗脑卒中后上肢痉挛的安全性和有效性。
前瞻性、随机、双盲、阳性药物对照、多中心、Ⅰ期临床试验。30 例脑卒中后上肢痉挛患者分别接受 MT10107 或注射用肉毒毒素 A 治疗。主要终点为治疗后第 4 周时腕屈肌改良 Ashworth 量表（MAS）评分较基线的变化。次要终点为肘、指屈肌 MAS 评分变化、应答率、残疾评估量表（DAS）和治疗总体评价。安全性终点包括不良事件、生命体征、体格检查和实验室检查等。疗效评估从基线到治疗后第 4 周。
主要终点为 MT10107 组和注射用肉毒毒素 A 组分别为-1.07±0.70 和-1.23±0.56。两组间差值为 0.17（95%置信区间-0.31 至 0.64，P=0.5769）。次要终点方面，两组 MAS 和 DAS 评分均有显著改善。两组间所有次要终点和安全性指标均无显著差异。
MT10107 治疗脑卒中后上肢痉挛的安全性和有效性与注射用肉毒毒素 A 无显著差异。
