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

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Jun 2017

At a glance

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

    • 07 Jun 2017 Primary endpoint (Subjects Global Impression of Change Scale (GICS) entry) has been met, according to a Merz North America media release.
    • 07 Jun 2017 Primary endpoint (Unstimulated salivary flow rate (uSFR)) has been met, according to a Merz North America media release.
    • 07 Jun 2017 Topline results from this trial published in a Merz North America Media Release.
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