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

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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2017

At a glance

  • Drugs Botulinum toxin A (Primary)
  • Indications Brain injuries; Cerebral palsy; Mental retardation; Sialorrhoea; Stroke
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SIPEXI
  • Sponsors Merz Pharma
  • Most Recent Events

    • 31 Jan 2017 Planned End Date changed from 1 Jun 2018 to 1 Jul 2019.
    • 31 Jan 2017 Planned primary completion date changed from 1 Feb 2017 to 1 May 2018.
    • 27 Jan 2015 Status changed from not yet recruiting to recruiting, as reported by ClinicalTrials.gov.
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