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BOTOX Treatment in Pediatric Upper Limb Spasticity: Open-label Study

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Trial Profile

BOTOX Treatment in Pediatric Upper Limb Spasticity: Open-label Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2021

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Adverse reactions; Registrational
  • Sponsors Allergan

    • Most Recent Events

    • 21 Jun 2019 According to an Allergan media release, the company announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics application (sBLA) for BOTOX for the treatment of pediatric patients (2 to 17 years of age) with upper limb spasticity.This approval is based on data from two Phase 3 studies included a 12-week, double-blind study and a one-year open label extension study.
    • 07 Mar 2019 According to an Allergan media release, the company announced that the U.S. Food and Drug Administration (FDA) has accepted the company's supplemental biologics license applications (sBLAs) to expand the onabotulinumtoxinA label for the treatment of pediatric patients (2 years of age and older) with upper and lower limb spasticity. sBLA submissions are based on data from four Phase 3 studies.
    • 10 Oct 2018 Status changed from active, no longer recruiting to completed.

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