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.
Keywords
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)To read this article in full you will need to make a payment
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Article info
Publication history
Published online: June 01, 2020
Footnotes
This research was supported by Medytox Inc., Republic of Korea.
Disclosures: none.
Clinical Trial Register No.: NCT03289702.
Identification
Copyright
© 2020 by the American Congress of Rehabilitation Medicine
