Overview

This trial has been completed.

Conditions chronic troublesome sialorrhea, parkinson's disease, post-stroke, traumatic brain injury
Treatments incobotulinumtoxina (100 units), incobotulinumtoxina (75 units), placebo
Phase phase 3
Sponsor Merz Pharmaceuticals GmbH
Start date April 2014
End date August 2015
Trial size 184 participants
Trial identifier NCT02091739, 2012-005539-10, MRZ60201_3090_1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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)
incobotulinumtoxina (100 units) Xeomin
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).
(Experimental)
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)
incobotulinumtoxina (75 units) Xeomin
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).
(Placebo Comparator)
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)
placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Primary Outcomes

Measure
Unstimulated salivary flow rate (uSFR)
time frame: Baseline to week 4
Subject's Global Impression of Change Scale (GICS) entry
time frame: Week 4

Secondary Outcomes

Measure
Unstimulated salivary flow rate
time frame: Baseline up to week 12
Subject's Global Impression of Change Scale (GICS) entry
time frame: Baseline up to week 12

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Merz Pharmaceuticals GmbH.