Efficacy and Safety of MT10107 (Coretox®) in Post-Stroke Upper Limb Spasticity Treatment: A Randomized, Double-Blind, Active Drug-Controlled, Multi-Center, Phase III Clinical Trial

Arch Phys Med Rehabil. 2020 Jun 1;S0003-9993(20)30309-9. doi: 10.1016/j.apmr.2020.03.025. Online ahead of print.

Abstract

Objective: To compare the efficacy and safety of MT10107 (Coretox®) with those of onabotulinum toxin A (Botox®) in patients with post-stroke upper limb spasticity DESIGN: A prospective, randomized, double-blind, active drug-controlled, multi-center, phase III clinical trial SETTING: Seven university hospitals in the Republic of Korea PARTICIPANTS: A total of 220 patients with post-stroke 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 and 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 post-intervention.

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 post-stroke upper limb spasticity treatment.

Keywords: botulinum toxin; safety; spasticity; stroke; upper extremity.