Phase III trial of Dysport (abobotulinumtoxinA) in brain injury patients with spasticity published in The Lancet Neurology- Ipsen

Ipsen announced that The Lancet Neurology has published clinical trial results showing the efficacy and safety of Dysport (abobotulinumtoxinA) in post-stroke or traumatic brain injury patients with upper limb spasticity. The international Phase III randomized, double-blind, placebo-controlled study of the efficacy and safety of Dysport was conducted in 34 neurology/rehabilitation clinics in nine countries.

The data gathered from 161 Dysport-treated patients showed statically significant changes in the severity of increased muscle tone measured by the mean change in Modified Ashworth Scale (MAS), the study’s primary endpoint, from baseline at week 4 in the primary target muscle group (PTMG) versus placebo (p ≤ 0.05). Improvements in muscle tone were reported at 1 week after injection and additional improvements in MAS score seemed to be maintained in the Dysport groups compared with placebo at weeks 16 and 20.