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: 13 Dec 2017

At a glance

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

    • 29 Nov 2017 Results published in the Media Release
    • 29 Nov 2017 According to an Ipsen media release, this study has been the basis for marketing authorization in the UK and Germany, in late 2016.
    • 29 Nov 2017 According to an Ipsen media release, detailed results from NCT01249404 and NCT01251367 studies have been published in the Neurology 2017.
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