A phase III, prospective, multicentre, open label, extension study, to assess the long term safety and efficacy of repeated treatment of Dysport intramuscular injection in the treatment of lower limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury

Trial Profile

A phase III, prospective, multicentre, open label, extension study, to assess the long term safety and efficacy of repeated treatment of Dysport intramuscular injection in the treatment of lower limb spasticity in adult subjects with spastic hemiparesis due to stroke or traumatic brain injury

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2017

At a glance

  • Drugs Botulinum toxin A (Primary)
  • Indications Muscle spasticity
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Ipsen
  • Most Recent Events

    • 29 Nov 2017 Results published in the Media Release
    • 29 Nov 2017 According to an Ipsen media release, detailed results from NCT01249404 and NCT01251367 studies have been published in the Neurology 2017.
    • 12 Oct 2017 Results (n=381) assessing relationship among adults with lower limb spasticity from stroke or traumatic brain injury from this and its parent study, presented at the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research.
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