Clinical Trials for Upper Limb Spasticity |XEOMIN®

Adults With Upper Limb Spasticity

Pivotal Trial Design

  • Randomized, placebo-controlled trial of XEOMIN for upper limb spasticity (PURE)1,2

Primary endpoints (main phase)2

  • Change from baseline in Ashworth Scale score for primary target clinical pattern
  • Investigator’s Global Impression of Change Scale (GICS)

Endpoints (OLEX phase)1,3

  • Ashworth Scale score
  • GICS
Pivotal trial design for Upper Limb Spasticity. Pinch to zoom Study Table Pinch to zoom

References

  1. XEOMIN® [Package insert]. Raleigh, NC: Merz Pharmaceuticals, LLC; 2019.
  2. Elovic EP, Munin MC, Kañovský 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.