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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)

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ClinicalTrials.gov Identifier: NCT02091739
Recruitment Status : Completed
First Posted : March 19, 2014
Results First Posted : February 15, 2018
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Troublesome Sialorrhea Parkinson's Disease Post-stroke Traumatic Brain Injury Drug: IncobotulinumtoxinA (100 Units) Drug: IncobotulinumtoxinA (75 Units) Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091739


Locations
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Germany
Merz investigational site #049172
Bonn, Germany, 53105
Merz Investigational Site #049335
Gera, Germany, 07551
Merz Investigational Site #049337
Haag i.OB, Germany, 83527
Merz Investigational Site #049072
Munich, Germany, 80804
Merz Investigational Site #049148
Munich, Germany, 81675
Merz Investigational Site #049300
Nümbrecht, Germany, 51588
Merz Investigational Site #049303
Regensburg, Germany, 93053
Merz investigational site #049348
Stadtroda, Germany, 07646
Merz Investigational Site #049143
Ulm, Germany, 89081
Merz Investigational Site #049333
Wolfach, Germany, 77709
Merz Investigational Site #049302
Wuerzburg, Germany, 97080
Poland
Merz investigational site #048068
Bydgoszcz, Poland, 85-015
Merz Investigational Site #048088
Bydgoszcz, Poland, 85-080
Merz Investigational Site #048029
Gdansk, Poland, 80-254
Merz investigational site #048074
Gdansk, Poland, 80-546
Merz investigational site #048078
Jaworzno, Poland, 43-600
Merz investigational site #048076
Katowice, Poland, 40-097
Merz investigational site #048077
Katowice, Poland, 40-097
Merz investigational Site #048067
Kielce, Poland, 25-103
Merz investigational site #048059
Krakow, Poland, 30-539
Merz investigational site #048031
Krakow, Poland, 31-505
Merz Investigational Site #048087
Krakow, Poland, 31-530
Merz Investigational Site #048022
Lodz, Poland, 90-130
Merz investigational site #048070
Lublin, Poland, 20-718
Merz investigational site #048085
Lublin, Poland, 30-539
Merz investigational site #048072
Lubon, Poland, 62-030
Merz Investigational Site #048075
Sandomierz, Poland, 27-600
Merz Investigational Site #048086
Torun, Poland, 87-100
Merz investigational site #048065
Warszawa, Poland, 00-453
Merz investigational site #048056
Warszawa, Poland, 02-097
Merz investigational site #048064
Warszawa, Poland, 03-242
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
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Study Director: Merz Medical Expert Merz Pharmaceuticals GmbH
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT02091739     History of Changes
Other Study ID Numbers: MRZ60201_3090_1
2012-005539-10 ( EudraCT Number )
First Posted: March 19, 2014    Key Record Dates
Results First Posted: February 15, 2018
Last Update Posted: March 27, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Sialorrhea
Parkinson Disease
Brain Injuries
Brain Injuries, Traumatic
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Salivary Gland Diseases
 Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
incobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents