At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 256 enrolled
Drug / intervention
NT 201 Placebo +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating NT 201 Placebo and NT 201 for Chronic Troublesome Sialorrhea and 4 related conditions. Completed, enrolled 256 participants across 31 sites in 6 countries.
Detailed Summary
The objective of this study is to investigate the efficacy and safety of NT 201 compared with placebo for the treatment of chronic troublesome sialorrhea associated with neurological disorders (e.g. cerebral palsy, traumatic brain injury) and/or intellectual disability in children and adolescents naïve to Botulinum neurotoxin treatment and aged 2-17 years.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Troublesome Sialorrhea, Cerebral Palsy, Stroke, Traumatic Brain Injury, Intellectual Disability
CountriesGeorgia, Hungary, Poland, Russia, Serbia, Ukraine
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 2014
Enrollment StartFeb 2015
Primary CompletionFeb 2018
Study CompletionMay 2019
TodayJul 2026
First PostedOct 21, 2014
Enrollment StartFeb 9, 2015
Primary CompletionFeb 23, 2018
Study CompletionMay 7, 2019
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 11.7 years ago
Interventions
NT 201 Placebodrug
NT 201 placebo matching injection.
NT 201drug
NT 201 injection.