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BotulinumtoxinA is an established treatment for cervical dystonia, but its effects sometimes wear off before 12 weeks. A randomized, double-blind, placebo-controlled, manufacturer-funded study was conducted to determine the efficacy, duration of response, and safety of daxibotulinumtoxinA (DAXI), tested at two dose levels, for cervical dystonia. Included were adults with moderate-to-severe cervical dystonia treated at one of 60 study sites in nine countries. The randomization was 3:3:1 to a single dose of 125U or 250U of intramuscular DAXI or placebo. The primary outcome was a change from baseline in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score averaged across weeks 4 and 6.
Among 301 persons randomized, the active-treat…