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

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Trial Profile

BOTOX Treatment in Pediatric Lower 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

  • 09 Jul 2020 According to an Allergan media release, the U.S. Food and Drug Administration (FDA) approved a supplemental Biologics License Application (sBLA) that supports expanded use of BOTOX for the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.
  • 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.
  • 05 Sep 2018 Status changed from active, no longer recruiting to completed.

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