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A Phase III, Multicentre, Prospective, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment 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, Open Label Extension Study to Assess the Long Term Safety and Efficacy of Repeated Treatment 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: 07 Nov 2021

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Muscle spasticity
  • Focus Adverse reactions; 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.
    • 21 Apr 2016 Long term safety and efficacy analysis (n=258) presented at the 68th Annual Meeting of the American Academy of Neurology.
    • 16 Jul 2015 According to an Ipsen Biopharmaceuticals media release, data from this study along with another pivotal study (see 700196084) was used to support the supplemental Biologics Application (sBLA) for Dysport (abobotulinumtoxinA) for use in treatment of Upper Limb Spasticity in Adults.
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