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BOTOX Treatment in Pediatric Upper Limb Spasticity: Double-blind Study

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Trial Profile

BOTOX Treatment in Pediatric Upper Limb Spasticity: Double-blind Study

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2019

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • 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) 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.
    • 01 Sep 2017 Status changed from recruiting to completed.

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