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Long-term Extension Study of BOTOX in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

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Trial Profile

Long-term Extension Study of BOTOX in the Treatment of Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Patients 5 to 17 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Oct 2021

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Urinary incontinence
  • Focus Registrational; Therapeutic Use
  • Sponsors Allergan
  • Most Recent Events

    • 10 Feb 2021 According to an AbbVie media release, the U.S. FDA has approved BOTOX for the treatment of detrusor (bladder muscle) overactivity associated with a neurologic condition in pediatric patients 5 years of age and older who have an inadequate response to or are intolerant of anticholinergic medication. The FDA approval is based on data from a randomized, double-blind Phase 3 study and a long-term extension study.
    • 10 Feb 2021 Results presented in an AbbVie media release.
    • 20 Dec 2019 Status changed from active, no longer recruiting to completed.
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