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
Condition: Chronic Troublesome Sialorrhea; Cerebral Palsy; Stroke; Traumatic Brain Injury; Intellectual Disability
MeSH terms: Sialorrhea; Brain Injuries; Cerebral Palsy; Brain Injuries, Traumatic; Intellectual Disability; Nervous System Diseases
Intervention: NT 201 Placebo; NT 201
Intervention description: NT 201 placebo matching injection.; NT 201 injection.
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 256.0
Sex: All
Minimum age: 2 Years
Maximum age: 17 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female child/adolescent age 2-17 years.

          -  Any neurological disorder (e.g. cerebral palsy or traumatic brain injury) and/or
             intellectual disability associated with chronic troublesome sialorrhea for at least 3
             months up to the screening. In subjects with intellectual disability (ID) without
             neurological disorders, a diagnosis of ID by a specialist, e.g. pediatrician or by a
             center for developmental medicine is required for inclusion.

          -  Severe drooling (modified Teacher´s Drooling Scale [mTDS] ≥ 6; clothing occasionally
             becomes damp) as rated by the investigator.

          -  Parental consent and the subject's oral or written assent as the subject is able to
             provide.

        Exclusion Criteria:

          -  Chronic troublesome sialorrhea not related to neurological disorders and/or
             intellectual disability.

          -  Body weight < 12 kg.

          -  Pharmacological treatment for sialorrhea or concomitant medication known to influence
             sialorrhea strongly (e.g. anticholinergics with exception of locally applied or short
             acting drugs used under general anesthesia) within 45 days before baseline and during
             the entire study period.

          -  Any previous known or suspected hypersensitivity to Botulinum toxin.

          -  Aspiration pneumonia within 6 month before screening.

          -  Any previous treatment with Botulinum toxin for any body region during the year before
             screening or within the screening period

          -  Prior, concomitant or planned surgery or irradiation to head and neck to control
             sialorrhea (including salivary gland surgery or salivary gland irradiation) within one
             year before screening or planned for any part of the entire study period.

          -  Concurrent diseases, including hematological, hepatic, renal, gastrointestinal,
             endocrine, pulmonary, musculoskeletal, or psychiatric diseases or conditions, which in
             the judgment of the investigator would put the subject at risk while in the study,
             could influence the results of the study, or negatively impact the subject's ability
             to participate in the study.

          -  Extremely poor dental and/or oral condition that might preclude safe study
             participation by the judgment of the investigator.

          -  Nursing mother or pregnant female subject.