Clinical Trials for Cervical Dystonia | XEOMIN®

Adults With Cervical Dystonia

Pivotal Trial Design

  • Randomized, placebo-controlled trial of XEOMIN in patients with cervical dystonia1,2

Primary endpoint

  • Change from baseline in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score at week 4 after injection of the main period1,2
Pivotal Study Design for Cervical Dystonia. Pinch to zoom

Studied in nearly 600 patients with cervical dystonia in clinical trials worldwide3

Study treatment table Pinch to zoom

Noninferiority Study Design

  • Randomized, active–controlled noninferiority trial of XEOMIN vs Botox® in patients with cervical dystonia4

Primary endpoint

  • Change from baseline in the TWSTRS severity score after week 44
Noninferiority Study Design for Cervical Dystonia. Pinch to zoom

ITT, intent–to–treat; TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale. TWSTRS total score includes subscales of Severity, Disability, and Pain.

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. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2019.
  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.
  3. Data on file. Raleigh, NC: Merz North America, Inc.; 2019.
  4. Benecke R, Jost WH, Kañovský P, Ruzicka E, Comes G, Grafe S. A new botulinum toxin type A free of complexing proteins for treatment of cervical dystonia. Neurology. 2005;64(11):1949–1951.