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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

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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: 06 Oct 2021

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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

    • 22 Apr 2021 Results assessing time to retreatment after abobotulinumtoxinA injections (Cycle 1) in upper-limb spasticity due to cerebral palsy, presented at the 73rd Annual Meeting of the American Academy of Neurology.
    • 01 May 2020 Results assessing the reduction in upper-limb spasticity following abobotulinumtoxinA injections for spasticity in children with cerebral palsy, presented at the 72nd Annual Meeting of the American Academy of Neurology.
    • 06 Jan 2020 According to an Ipsen media release, the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence update for Dysport for the symptomatic treatment of focal spasticity of upper limbs in pediatric cerebral palsy patients, two years of age and older.

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