Efficacy and Safety of IncobotulinumtoxinA in Subjects Previously Treated with Botulinum Toxin Versus Toxin-Naive Subjects with Cervical Dystonia.

ABSTRACT: To determine whether botulinum toxin treatment history affected the outcomes of a study comparing the safety and efficacy of incobotulinumtoxinA with placebo in subjects with cervical dystonia (CD). This was a prospective, double-blind, randomized, placebo-controlled, multicenter trial in botulinum toxin-treated or toxin-naïve CD subjects. Subjects received a fixed dose of either 120 U or 240 U of incobotulinumtoxinA or placebo. The primary outcome measure was change from baseline to Week 4 in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score. Treatment-emergent adverse events (TEAEs) were also evaluated. This report represents a subgroup analysis of botulinum toxin-treated or toxin-naïve subjects. Participants (N = 233; 38.6% toxin-naïve) had a mean age of 52.8 y

SUBMITTER: Fernandez HH 

PROVIDER: S-EPMC3629862 | biostudies-literature | 2013

REPOSITORIES: biostudies-literature