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A Phase III, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT Used In The Treatment Of Upper Limb Spasticity In Children

Trial Profile

A Phase III, Multicentre, Double Blind, Prospective, Randomised, Controlled, Multiple Treatment Study Assessing Efficacy And Safety Of DYSPORT Used In The Treatment Of Upper Limb Spasticity In Children

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2019

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Acronyms PUL
  • Sponsors Ipsen
  • Most Recent Events

    • 26 Sep 2019 Primary endpoint has been met. (Mean change from baseline in the Primary Targeted Muscle Group on Modified Ashworth Scale (MAS)), according to an Ipsen media release.
    • 26 Sep 2019 Results presented in an Ipsen media release.
    • 26 Sep 2019 According to an Ipsen media release, based on the data from this study, the United States Food and Drug Administration (FDA) has expanded the use of Dysport (abobotulinumtoxinA) for injection to include the treatment of upper limb spasticity in children two years of age and older, excluding spasticity caused by cerebral palsy (CP).
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