XEOMIN Safety Profile in the Treatment of Cervical Dystonia

Safety demonstrated in a randomized, double-blind, placebo-controlled trial of XEOMIN® (incobotulinumtoxinA)1

Study design

Phase 3, multicenter, double-blind study in 233 patients who were randomized to receive a single treatment of XEOMIN 240 units (n=81), XEOMIN 120 units (n=78), or placebo (n=74). Male and female patients 18 to 75 years of age were eligible if they had cervical dystonia of predominantly rotational form and a TWSTRS Total Score ≥20. Patients previously treated with botulinum toxin were eligible but only if ≥10 weeks had passed since their last injection. Patients had TWSTRS Severity Score ≥10, TWSTRS Disability Score ≥3, and TWSTRS Pain Score ≥1. Patients with swallowing disorders or any significant neuromuscular disease that might interfere with the study were excluded from enrollment.1,2

hcp_2.2_treatment_emergent_aes_table

References

  1. XEOMIN® [package insert]. Raleigh, NC: Merz North America, Inc; 2015.
  2. Comella CL, Jankovic J, Truong DD, Hanschmann A, Grafe S; US XEOMIN Cervical Dystonia Study Group. Efficacy and safety of incobotulinumtoxinA (NT 201, XEOMIN®, botulinum neurotoxin type A, without accessory proteins) in patients with cervical dystonia. J Neurol Sci. 2011;308(1-2):103‐109.