Safety and efficacy of MT10107 in post-stroke upper limb spasticity treatment: A phase I randomized controlled trial.

ABSTRACT:

Background

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.

Methods

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 trea

SUBMITTER: Lee J 

PROVIDER: S-EPMC9646656 | biostudies-literature | 2022 Nov

REPOSITORIES: biostudies-literature