CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 184 enrolled
Drug / intervention
IncobotulinumtoxinA (100 Units) +2 moredrug
Likely dose
IncobotulinumtoxinA (100 Units)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02091739
NCT02091739Phase 3Completed
CompareCT.gov

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

Merz Pharmaceuticals GmbH·interventional·Posted Mar 19, 2014·Updated Mar 27, 2018

In Brief

A Phase 3 clinical trial evaluating IncobotulinumtoxinA (100 Units), IncobotulinumtoxinA (75 Units), and 1 other intervention for Chronic Troublesome Sialorrhea and 3 related conditions. Completed, enrolled 184 participants across 31 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Troublesome Sialorrhea, Parkinson's Disease, Post-stroke, Traumatic Brain Injury
CountriesGermany, Poland
Collaborators--

Timeline

Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 19, 2014
Enrollment StartApr 1, 2014
Primary CompletionAug 1, 2015
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.3 years ago

Interventions

IncobotulinumtoxinA (100 Units)drug

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).

IncobotulinumtoxinA (75 Units)drug

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).

Placebodrug

Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).