Safety and efficacy of letibotulinumtoxinA(BOTULAX®) in treatment of post stroke upper limb spasticity: a randomized, double blind, multi-center, phase III clinical trial.

OBJECTIVE: To investigate a new botulinum neurotoxin type A, termed letibotulinumtoxinA(Botulax®) and compare its efficacy and safety for post-stroke upper limb spasticity with that of onabotulinumtoxinA(Botox®). DESIGN: A prospective, double-blinded, multicenter, randomized controlled clinical study. SETTING: Six university hospitals in Korea. SUBJECTS: A total of 187 stroke participants with upper limb spasticity. INTERVENTIONS: Two kinds of botulinum neurotoxin type A were used. One set of injection was performed and total injected doses were 309.21±62.48U(Botulax) and 312.64±49.99U(Botox)( P>0.05). MAIN MEASURES: Primary outcome was measured using the modified Ashworth scale for wrist flexors at week 4 and secondary outcome was measured using modified Ashworth scale for wrist flexors, elbow flexors, finger flexors, and thumb flexors as well as Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale. Safety measures including adverse events, vital signs and physical examination, and laboratory tests were also monitored. RESULTS: The mean ages for the Botulax group were 56.81±9.49 and which for the Botox group were 56.93±11.93( P>0.05). In primary outcome, the change in modified Ashworth scale for wrist flexors was -1.45±0.61 in the Botulax group and -1.40±0.57 in the Botox group, and the difference between the two groups was -0.06(95% CI:-0.23-0.12, P>0.05). In secondary outcome, both groups demonstrated significant improvements with respect to modified Ashworth scale, Global Assessment in spasticity, Disability Assessment Scale, and Caregiver Burden Scale ( P<0.05), and no significant difference was observed between the two groups ( P>0.05). In addition, safety measures showed no significant differences between the two groups ( P>0.05). CONCLUSIONS: The efficacy and safety of Botulax were comparable with those of Botox in treatment of post-stoke upper limb spasticity.