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This multicenter, double-blind, manufacturer-funded study examined whether a single abobotulinumtoxinA injection in the lower limb after stroke or brain injury was safe and efficacious. Patients were required to have lower limb spasticity for at least 6 months following stroke or brain injury. Patients received one injection of 1000 U, 1500 U, or placebo followed by up to four open-label injections, each separated by ≥3 months. The primary outcome variable was the Modified Ashworth Scale (MAS) in the gastrocnemius soleus complex. Other outcomes included the physician global assessment and comfortable barefoot walking speed. The open label follow-up endpoint was safety.
Double-blind follow-up at 4 and 12 weeks showed a significantly greater r…