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 (SIAXI)

February 27, 2018 updated by: Merz Pharmaceuticals GmbH

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

184

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Merz investigational site #049172
      • Gera, Germany, 07551
        • Merz Investigational Site #049335
      • Haag i.OB, Germany, 83527
        • Merz Investigational Site #049337
      • Munich, Germany, 80804
        • Merz Investigational Site #049072
      • Munich, Germany, 81675
        • Merz Investigational Site #049148
      • Nümbrecht, Germany, 51588
        • Merz Investigational Site #049300
      • Regensburg, Germany, 93053
        • Merz Investigational Site #049303
      • Stadtroda, Germany, 07646
        • Merz investigational site #049348
      • Ulm, Germany, 89081
        • Merz Investigational Site #049143
      • Wolfach, Germany, 77709
        • Merz Investigational Site #049333
      • Wuerzburg, Germany, 97080
        • Merz Investigational Site #049302
  • Poland
      • Bydgoszcz, Poland, 85-015
        • Merz investigational site #048068
      • Bydgoszcz, Poland, 85-080
        • Merz Investigational Site #048088
      • Gdansk, Poland, 80-254
        • Merz Investigational Site #048029
      • Gdansk, Poland, 80-546
        • Merz investigational site #048074
      • Jaworzno, Poland, 43-600
        • Merz investigational site #048078
      • Katowice, Poland, 40-097
        • Merz investigational site #048076
      • Katowice, Poland, 40-097
        • Merz investigational site #048077
      • Kielce, Poland, 25-103
        • Merz investigational Site #048067
      • Krakow, Poland, 30-539
        • Merz Investigational Site #048059
      • Krakow, Poland, 31-505
        • Merz Investigational Site #048031
      • Krakow, Poland, 31-530
        • Merz Investigational Site #048087
      • Lodz, Poland, 90-130
        • Merz Investigational Site #048022
      • Lublin, Poland, 20-718
        • Merz investigational site #048070
      • Lublin, Poland, 30-539
        • Merz investigational site #048085
      • Lubon, Poland, 62-030
        • Merz Investigational Site #048072
      • Sandomierz, Poland, 27-600
        • Merz Investigational Site #048075
      • Torun, Poland, 87-100
        • Merz Investigational Site #048086
      • Warszawa, Poland, 00-453
        • Merz investigational site #048065
      • Warszawa, Poland, 02-097
        • Merz Investigational Site #048056
      • Warszawa, Poland, 03-242
        • Merz investigational site #048064

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IncobotulinumtoxinA (Xeomin) (100 Units)
  • 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)
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).
Other Names:
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Experimental: IncobotulinumtoxinA (Xeomin) (75 Units)
  • 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)
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).
Other Names:
  • Xeomin
  • NT 201
  • Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Placebo Comparator: Placebo
  • 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)
Drug: Placebo
Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4
Time Frame: Baseline and Week 4
uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.
Baseline and Week 4
MP: Participant's Global Impression of Change Scale (GICS) at Week 4
Time Frame: Week 4
The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.
Week 4

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12
Time Frame: Baseline, Week 8 and 12
uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.
Baseline, Week 8 and 12
MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12
Time Frame: Week 1, 2, 8, and 12
The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.
Week 1, 2, 8, and 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Pharmaceuticals GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

March 18, 2014

First Submitted That Met QC Criteria

March 18, 2014

First Posted (Estimate)

March 19, 2014

Study Record Updates

Last Update Posted (Actual)

March 27, 2018

Last Update Submitted That Met QC Criteria

February 27, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRZ60201_3090_1
  • 2012-005539-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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