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XEOMIN® - Clinical Trials for Blepharospasm

Adults With Blepharospasm

Disease
Overview
Clinical
Trials
Efficacy Safety Dosing

Pivotal Study Design in Treatment-Naïve Patients

Randomized, Double-Blind, Placebo-Controlled Trial of XEOMIN in Treatment-Naïve Patients With Blepharospasm2

Primary endpoint:
Change in Jankovic Rating Scale Severity Subscore after 6 weeks

Change in Jankovic Rating Scale Severity Subscore after 6 weeks

*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 units was not statistically significant when compared with placebo at week 6 (P=.1452)

Pivotal Study Details in Treatment-Naïve Patients

Patient population2

Patients had a clinical diagnosis of blepharospasm, with a baseline Jankovic Rating Scale (JRS) severity subscore ≥2

Patients were defined as treatment-naïve if at least 12 months had passed since their last botulinum toxin treatment for blepharospasm

Of the 61 patients randomized, 55 patients completed the placebo-controlled phase. Patients only continued to the open-label extension (OLEX) period if they had a confirmed need for a re-injection by week 20 of the placebo-controlled phase. A total of 39 patients entered and completed the OLEX phase

Methods2

During the placebo-controlled phase, a fixed total dose of XEOMIN 25 units (n=22), XEOMIN 50 units (n=19), or placebo (n=20) was administered intramuscularly at 6 injection sites per eye

Results2

The primary efficacy variable was the change from baseline in JRS Severity subscore determined at week 6 after the injection. The XEOMIN 50 Unit treatment group demonstrated statistically significant improvements compared to placebo, with a difference of -1.2 (P=0.0004). The change from baseline in the JRS Severity subscore for the XEOMIN 25 Unit treatment group 6 weeks after the injection was not statistically significant, with a difference of -0.5 (P=0.1452) compared to placebo

Studied in nearly 400 patients with blepharospasm in clinical trials worldwide3

Pivotal Study Design in Patients Pretreated With Botox®

Randomized, Double-Blind, Placebo-Controlled Trial of XEOMIN in Patients With Blepharospasm Pretreated With Botox2

Primary endpoint:
Change in JRS Severity subscore after 6 weeks

Change in JRS Severity Subscore after 6 weeks

Placebo-controlled (main) period treatment individualized per patient; dosing, dilution, volume, and injection sites based on last 2 Botox treatments

Pivotal Study Design Details in Patients Pretreated with Botox

Patient population

Patients with any significant neuromuscular disease that might interfere with the study were excluded from enrollment. Patients were randomized (2:1) to receive a single dose of XEOMIN (n=75) or placebo (n=34). The mean age of the study patients was 63 years, and 65% of the patients were women2

The study was completed by 94% of study patients. Approximately one-third of patients had other dystonic phenomena; in all but 1% this was limited to facial, cervical, perioral, and mandibular muscles. No patients discontinued the study prematurely due to adverse events2

Methods

Noninferiority Study Design

Randomized, Double-Blind, Active-Controlled Noninferiority Trial of
XEOMIN vs Botox in Patients with Blepharospasm3

Primary endpoint:
Change in JRS after 3 weeks

Change in JRS after 3 weeks

§Subjects had the opportunity to come for optional visits whenever a need for injection was felt. Whenever a new injection was necessary, the final-visit evaluation was performed.

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. Data on file. Raleigh, NC: Merz North America, Inc.; 2019.
  2. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2019.
  3. Roggenkamper P, Jost WH, Bihari K, Comes G, Gafe 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.