Upper Limb Spasticity in Adults

XEOMIN Significantly Improved Muscle Tone vs Placebo (P<0.001)1

  • Significant difference was seen in the mean change on the Ashworth Scale between XEOMIN and placebo (P<0.001)1
    • Investigators evaluated 3 total primary target clinical patterns: flexed wrist, flexed elbow, or clenched fist1
    • Ashworth Scale is a clinical measure of the severity of spasticity by judging resistance to passive movement1
XEOMIN® demonstrated improvements in muscle tone.

*The analysis is based on last observation carried forward in the full analysis set.
P<0.001.

XEOMIN Patients’ Functional Improvement was Superior to Placebo1

  • XEOMIN patients had improvements in overall upper limb spasticity as measured by the Investigators’ Global Impression of Change Scale (GICS)1
    • Mean GICS score for XEOMIN was 0.3 points higher than placebo at Week 4; P<0.0031
    • Investigators were asked to evaluate the patients’ global change in spasticity of the upper limb due to treatment, compared to the condition before the last injection1
    • GICS is a global measure of a patient's functional improvement1
XEOMIN® improved patients' functional improvement.

Pivotal Trial Design

Randomized, Placebo-controlled Trial of XEOMIN for
Upper Limb Spasticity (PURE)1‑3

Pivotal trial design for upper limb spasticity.

References

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2021.
  2. Elovic EP, Munin MC, Kaňovský P, Hanschmann A, Hiersemenzel R, Marciniak C. Randomized, placebo-controlled trial of incobotulinumtoxinA for upper limb post-stroke spasticity. Muscle Nerve. 2016;53(3):415-421.
  3. Marciniak C, Munin MC, Brashear A, et al. IncobotulinumtoxinA efficacy and safety in adults with upper-limb spasticity following stroke: results from the open-label extension period of a phase 3 study. Adv Ther. 2019;36(1):187-199.

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Reference

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2021.