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
Phase of Trial: Phase III
Latest Information Update: 27 Sep 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
- 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.