To compare the efficacy and safety of MT10107 (Coretox) with those of onabotulinum toxin A (Botox) in patients with poststroke upper limb spasticity
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).
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.
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.
List of abbreviations:BTX-A (botulinum toxin type A), CI (confidence interval), DAS (Disability Assessment Scale), FAS (full analysis set), HSA (human serum albumin), MAS (modified Ashworth Scale), PPS (per protocol set)
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Published online: June 01, 2020
This research was supported by Medytox Inc., Republic of Korea.
Clinical Trial Register No.: NCT03289702.
© 2020 by the American Congress of Rehabilitation Medicine