A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy

Trial Profile

A Phase III, Multicentre, Double Blind, Prospective, Randomised, Placebo Controlled Study Assessing the Efficacy and Safety of DYSPORT Used in the Treatment of Lower Limb Spasticity in Children With Dynamic Equinus Foot Deformity Due to Cerebral Palsy

Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jan 2018

At a glance

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

    • 09 Jan 2018 According to an Ipsen Biopharmaceuticals media release, Health Canada has approved DYSPORT THERAPEUTIC™ (abobotulinumtoxinA) for the treatment of lower limb spasticity in pediatric patients two years of age and older based on data from this trial.
    • 21 Sep 2016 Results will be presented at the annual meeting of the American Academy of Cerebral Palsy and Developmental Medicine, as per Ipsen media release.
    • 15 Sep 2016 Results of a pooled analysis from 8-trials will be presented at the annual meeting of the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM), as reported by Ipsen Biopharmaceuticals media release.
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