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.
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Change From Baseline in Unstimulated Salivary Flow Rate (uSFR) at Week 4
Timeframe: Baseline and Week 4
Global Impression of Change Scale (GICS) at Week 4 Assessed by the Carer/Parent(s)
Timeframe: Week 4
Occurrence of Treatment Emergent Adverse Events (TEAEs) Overall and Per Injection Cycle
Timeframe: Baseline up to Week 64