Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions
Condition: Chronic Troublesome Sialorrhea; Parkinson's Disease; Post-stroke; Traumatic Brain Injury
MeSH terms: Sialorrhea; Parkinson Disease; Brain Injuries; Brain Injuries, Traumatic
Intervention: IncobotulinumtoxinA (100 Units); IncobotulinumtoxinA (75 Units); Placebo
Intervention description: Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).; Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
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: 184.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The objective of this study is to investigate the efficacy and safety of two different dose
      levels of NT 201 (75 U or 100 U per cycle), compared with placebo, in reducing the salivary
      flow rate, and the severity and frequency of chronic troublesome sialorrhea that occurs as a
      result of various neurological conditions in adult subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented diagnosis of the basic neurological condition associated with sialorrhea
             (as above, (i), (ii) or (iii); with onset at least 6 months before screening).

          -  Chronic troublesome sialorrhea related to parkinsonism or stroke or traumatic brain
             injury (for at least 3 months) at screening, defined as the presence of all of the
             following, at screening and at baseline and for at least the 3 months before screening
             (where retrospective response to questionnaires is impossible, a statement of
             equivalent severity will suffice):

               1. A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and

               2. A score of at least 2 points for each item of the DSFS and

               3. A score of at least 3 points on the modified Radboud Oral Motor Inventory for
                  Parkinson's Disease [mROMP], Section 'III Drooling', Item A).

          -  A score of at most 2 points on the mROMP Section 'II Swallowing Symptoms' Item A) and
             a score of at most 3 points on Item C), at screening and at baseline.

        Exclusion Criteria:

          -  Non-neurological secondary causes of sialorrhea.

          -  Unstable concomitant medication influencing sialorrhea (such as anticholinergics for
             the treatment of parkinsonism; dosages of these medications must have been stable for
             at least 4 weeks before study entry, i.e. screening, and must be planned to remain
             stable during the course of the study.

          -  Recent (i.e., four weeks) drug treatment for sialorrhea.

          -  History of recurrent aspiration pneumonia.

          -  Extremely poor dental/oral condition as assessed by a qualified dentist.

          -  Recent (i.e., one year for sialorrhea, 14 weeks for other indications) treatment with
             - or known hypersensitivity to - Botulinum toxin, or known hypersensitivity to any
             ingredient of the study preparation.

          -  Recent (i.e., four weeks) changes in anti-parkinsonian medication.

          -  Previous or planned surgery or irradiation to control sialorrhea.