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Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Children and Adolescents (2-17 Years) With Chronic Troublesome Sialorrhea Associated With Neurological Disorders, and/or Intellectual Disability

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Trial Profile

Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study With an Open-label Extension Period to Investigate the Efficacy and Safety of NT 201 in the Treatment of Children and Adolescents (2-17 Years) With Chronic Troublesome Sialorrhea Associated With Neurological Disorders, and/or Intellectual Disability

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Oct 2021

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At a glance

  • Drugs Botulinum-Toxin-A (Primary)
  • Indications Cerebral palsy; Mental retardation; Sialorrhoea; Stroke; Traumatic brain injuries
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SIPEXI
  • Sponsors Merz Pharmaceuticals GmbH

Most Recent Events

  • 22 Sep 2021 Results presented at the 25th International Congress of Parkinson's Disease and Movement Disorders
  • 31 Aug 2021 According to a Merz Therapeutics media release, based on the results from this study XEOMIN(incobotulinumtoxinA) receives European approval for the symptomatic treatment in children and adolescents aged 2 to 17 years and weighing greater than or equal to 12 kg of chronic sialorrhea due to neurological / neurodevelopmental disorders on EU level.
  • 02 Aug 2021 Primary endpoint has been met (Global Impression of Change Scale [GICS] at Week 4 representing the functional improvement in drooling since baseline as assessed by the carer/parent(s)) , according to Results published in the Neurology

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