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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

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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: 05 Nov 2022

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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

    • 18 Sep 2022 Results presented at the 26th International Congress of Parkinson's Disease and Movement Disorders
    • 01 Dec 2020 According to a Merz Therapeutics media release, based on this study, the company announced that Health Canada notice of compliance for XEOMIN (incobotulinumtoxinA) for the treatment of chronic sialorrhea, or excessive drooling, associated with neurological disorders in adult patients.
    • 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.
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