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Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions

Trial Profile

Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 May 2019

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Sialorrhoea
  • Focus Registrational; Therapeutic Use
  • Acronyms SIAXI
  • Sponsors Merz Pharma
  • Most Recent Events

    • 29 May 2019 According to Merz North America Media release, based on the data from this trial, Xeomin (incobotulinumtoxinA) has received the European approval for the symptomatic treatment of chronic sialorrhea (drooling) due to neurological disorders in adult patients.
    • 27 Mar 2019 Results evalauting the efficacy and safety of incobotulinumtoxinA for the treatment of chronic sialorrhea published in the Neurology
    • 09 Oct 2018 Results presented at the 22nd International Congress of Parkinson's Disease and Movement Disorders
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