Clinical Study to Investigate the Efficacy and Safety of NT 201 Compared to Placebo in the Treatment of Chronic Troublesome Drooling Associated With Neurological Disorders and/or Intellectual Disability

clinical trial

Details

Instance of: clinical trial
Start time: 18 December 2014
End time: 23 February 2018
Country: Georgia, Hungary, Poland, Serbia, Ukraine
Main subject: intellectual disability, cerebral palsy
clinical trial phase: phase III clinical trial
maximum age: 17
minimum age: 2
number of participants: 249
research intervention: botulinum toxin type A
research subject recruitment status: completed
short name: SIPEXI
study type: interventional study
title: 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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