Conditions: Chronic Troublesome Sialorrhea Parkinson's Disease Post-stroke Traumatic Brain Injury
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 184
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: * Main period (1 treatment cycle): Subjects to receive 100 Units.
* Extension period (3 treatment cycles): Subjects to receive 100 Units per treatment cycle.
* Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral) arm 2: * Main period (1 treatment cycle): Subjects to receive 75 Units.
* Extension period (3 treatment cycles): Subjects to receive 75 Units per treatment cycle.
* Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral) arm 3: * Main period (1 treatment cycle): Subjects to receive placebo injection.
* Extension period (3 treatment cycles): Subjects will be randomized to receive either 75 or 100 Units IncobotulinumtoxinA per treatment cycle.
* Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)

Interventions: intervention 1: IncobotulinumtoxinA (100 Units) intervention 2: IncobotulinumtoxinA (75 Units) intervention 3: Placebo
Intervention descriptions: intervention 1: 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). intervention 2: 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). intervention 3: Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Protocol document: