A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, PLACEBO CONTROLLED STUDY, ASSESSING THE EFFICACY AND SAFETY OF DYSPORT USED FOR THE TREATMENT OF LOWER LIMB SPASTICITY IN ADULT SUBJECTS WITH HEMIPARESIS DUE TO STROKE OR TRAUMATIC BRAIN INJURY

Trial Profile

A PHASE III, MULTICENTRE, DOUBLE BLIND, PROSPECTIVE, RANDOMISED, PLACEBO CONTROLLED STUDY, ASSESSING THE EFFICACY AND SAFETY OF DYSPORT USED FOR THE TREATMENT OF LOWER LIMB SPASTICITY IN ADULT SUBJECTS WITH HEMIPARESIS DUE TO STROKE OR TRAUMATIC BRAIN INJURY

Completed
Phase of Trial: Phase III

Latest Information Update: 20 Mar 2018

At a glance

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

    • 20 Mar 2018 According to an Ipsen media release, Health Canada has approved DYSPORT THERAPEUTI (abobotulinumtoxinA) for the symptomatic treatment of focal spasticity affecting the lower limbs in adults based on this and its extension study (700229803).
    • 15 Feb 2018 According to an Ipsen media release, data from this trial will be presented at the annual meeting of the Association of Academic Physiatrists (AAP) 2018.
    • 29 Nov 2017 Results published in the Media Release
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