NCT02091739

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

Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group Multicenter Study, With an Extension Period of Dose-blinded Active Treatment, to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Troublesome Sialorrhea
• Parkinson's Disease
• Post-stroke
• Traumatic Brain Injury

Interventions

Type	Name	Description
DRUG	IncobotulinumtoxinA (100 Units)	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).
DRUG	IncobotulinumtoxinA (75 Units)	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).
DRUG	Placebo	Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• Completion: 2016-11-01
• First posted: 2014-03-19
• Last updated: 2018-03-27
• Results posted: 2018-02-15

Locations

31 sites across 2 countries: Germany, Poland