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A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

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Trial Profile

A Phase III, Multicentre, Prospective, Double Blind, Randomised, Placebo Controlled Study, Assessing the Efficacy and Safety of Dysport Intramuscular Injections Used for the Treatment of Upper Limb Spasticity in Adult Subjects With Spastic Hemiparesis Due to Stroke or Traumatic Brain Injury

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Aug 2019

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Registrational; Therapeutic Use
  • Sponsors Ipsen

    • Most Recent Events

    • 28 Apr 2017 Results of additional analysis assessing the duration of effect of aboBoNT-A injections over repeated treatment cycles in hemiparetic patients with upper limb spasticity (double-blind study- NCT01313299 and open- label extension- NCT01313312), presented at the 69th Annual Meeting of the American Academy of Neurology.
    • 14 Mar 2017 According to an Ipsen media release, health Canada has approved Dysport (abobotulinumtoxinA) in the treatment of upper limb spasticity in adult patients; the approval was based on data from this study.
    • 02 Sep 2015 According to Ipsen media release, results published in the Lancet Neurology.
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