Clinical Trials for Blepharospasm | XEOMIN®

Adults With Blepharospasm

Pivotal Study Design in Treatment-Naïve Patients

  • Randomized, double–blind, placebo–controlled trial of XEOMIN in treatment–naïve patients with blepharospasm1

Primary endpoint

  • Change in Jankovic Rating Scale (JRS) severity subscore after 6 weeks1
Change in Jankovic Rating Scale Severity Sub score after 6 weeks Pinch to zoom

*At the end of the initial 20–week placebo–controlled phase, patients had the option to enroll in an open–label extension if they had a confirmed need for a re–injection.
†XEOMIN 25 U was not statistically significant when compared with placebo at week 6 (P=0.1452).

Study treatment table Pinch to zoom

Studied in nearly 400 patients with blepharospasm in clinical trials worldwide2

Pivotal Study Design in Patients Previously Treated With Botox®

  • Randomized, double–blind, placebo–controlled trial of XEOMIN in patients with blepharospasm previously treated with Botox3

Primary endpoint

  • Change in JRS severity subscore after 6 weeks3
Change in JRS Severity Sub score after 6 weeks Pinch to zoom Treatment table Pinch to zoom

Noninferiority Study Design

  • Randomized, double-blind, active-controlled noninferiority trial of XEOMIN vs Botox in patients with blepharospasm4

Primary endpoint

  • Change in JRS after 3 weeks
Change in JRS after 3 weeks Pinch to zoom

‡Intent–to–treat.

The potency Units of XEOMIN are specific to the preparation and assay method utilized. They are not interchangeable with the other preparations of botulinum toxin products and, therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products assessed with any other specific assay method.

References

  1. Mitsikostas DD, Dekundy A, Sternberg K, Althaus M, Pagan F. Long–term safety and efficacy of incobotulinumtoxinA for the treatment of blepharospasm in botulinum toxin–naïve subjects: results of a phase III study. Poster presented at: Toxins; January 16–19, 2019; Copenhagen, Denmark.
  2. Data on file. Raleigh, NC: Merz North America, Inc.; 2019.
  3. Jankovic J, Comella C, Hanschmann A, Grafe S. Efficacy and safety of incobotulinumtoxinA (NT 201, Xeomin) in the treatment of blepharospasm—a randomized trial. Mov Disord. 2011;26(8):1521–1528.
  4. Roggenkämper P, Jost WH, Bihari K, Comes G, Grafe S; for the NT 201 Blepharospasm Study Team. Efficacy and safety of a new botulinum toxin type A free of complexing proteins in the treatment of blepharospasm. J Neural Transm (Vienna). 2006;113(3):303–312.