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XEOMIN - Clinical Trials for Cervical Dystonia

Adults With Cervical Dystonia

Disease
Overview
Clinical
Trials
Efficacy Safety Dosing

Pivotal Study Design

Randomized, Placebo-Controlled Trial of XEOMIN in Patients With Cervical Dystonia1,2

Primary endpoint:
Change from baseline in the TWSTRS total score at week 4 after injection of the main period

Pivotal Study Design

TWSTRS, Toronto Western Spasmodic Torticollis Rating Scale. TWSTRS total score includes subscales of Severity, Disability, and Pain.

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

Injection sites

Each patient received a single administration of 4.8 mL of reconstituted study agent (XEOMIN 240 units, XEOMIN 120 units, or placebo)1

The investigator at each site decided which muscles would receive injections of the study agent, the number of injection sites, and the volume at each site1

Most patients received a total of 2–10 injections into the selected muscles. Patients were assessed by telephone at 1 week post-injection, during clinic visits at weeks 4 and 8, and then by telephone assessments or clinic visits every 2 weeks up to week 201

Patient population

The mean age of the study patients was 53 years, and 66% of the patients were women. At study baseline, 61% of patients had previously received a botulinum toxin as treatment for cervical dystonia. The study was completed by 94% of study patients. Three patients discontinued the study prematurely due to adverse events: two patients in the 240 unit group experienced musculoskeletal pain and muscle weakness, and one patient in the 120-unit group experienced nausea and dizziness.1

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 4

Noninferiority Study Design

ITT, intention-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; for the 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. 2001;308(1-2):103-109.
  3. Data on file. Raleigh, NC: Merz North America, Inc.; 2019.
  4. Benecke R, Jost WH, Kanovsky P, Ruzicka E, Comes G, Grafe S. A new botulinum toxin type A free of complexing proteins for treatment of cerical dystonia. Neurology. 2005;64(11):1949-1951.