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
Price :
$35
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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
- 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