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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Merz Pharmaceuticals GmbH
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT02091739
First received: March 18, 2014
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Unstimulated salivary flow rate (uSFR) [ Time Frame: Baseline to week 4 ] [ Designated as safety issue: No ]
    uSFR: weighing of dental rolls soaked with saliva over 5 minutes; procedure repeated after 30 minutes. The reduction of measured weight over the study relates to improvement of sialorrhea.

  • Subject's Global Impression of Change Scale (GICS) entry [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

    This is a co-primary outcome measure. The GICS is used to measure the investigator's impression of change due to treatment. The response option is a common 7-point Likert scale that ranges from -3 = very much worse to +3 = very much improved.

    If the subject is not able to answer: carer's GICS entry.



Secondary Outcome Measures:
  • Unstimulated salivary flow rate [ Time Frame: Baseline up to week 12 ] [ Designated as safety issue: No ]
  • Subject's Global Impression of Change Scale (GICS) entry [ Time Frame: Baseline up to week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 180
Study Start Date: April 2014
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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 (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 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.
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02091739

Contacts
Contact: Public Disclosure Manager clinicaltrials@merz.de

Locations
Germany
Merz investigational site #049072 Recruiting
Muenchen, Bavaria, Germany, 80804
Merz investigational site #049133 Recruiting
Bennewitz, Germany, 04828
Merz Investigational Site #049335 Recruiting
Gera, Germany, 07551
Merz Investigational Site #049337 Recruiting
Haag i.OB, Germany, 83527
Merz investigational site #049334 Recruiting
Leipzig, Germany, 04103
Merz Investigational Site #049336 Recruiting
Westerstede, Germany, 26655
Merz Investigational Site #049333 Recruiting
Wolfach, Germany, 77709
Poland
Merz investigational site #048068 Recruiting
Bydgoszcz, Poland, 85-015
Merz investigational site #048074 Recruiting
Gdansk, Poland, 80-546
Merz investigational site #048078 Recruiting
Jaworzno, Poland, 43-600
Merz investigational site #048077 Recruiting
Katowice, Poland, 40-097
Merz investigational site #048073 Recruiting
Katowice, Poland, 40-555
Merz investigational site #048076 Recruiting
Katowice, Poland, 40-097
Merz investigational site #048079 Recruiting
Konstancin, Poland, 05-510
Merz investigational site #048031 Recruiting
Krakow, Poland, 31-505
Merz investigational site #048059 Recruiting
Krakow, Poland, 30-539
Merz Investigational Site #048022 Recruiting
Lodz, Poland, 90-130
Merz investigational site #048071 Recruiting
Lodz, Poland, 90-302
Merz investigational site #048069 Recruiting
Lublin, Poland, 20-093
Merz investigational site #048070 Recruiting
Lublin, Poland, 20-718
Merz investigational site #048072 Recruiting
Lubon, Poland, 62-030
Merz Investigational Site #048075 Recruiting
Sandomierz, Poland, 27-600
Merz investigational site #048064 Recruiting
Warszawa, Poland, 03-242
Merz investigational site #048033 Recruiting
Warszawa, Poland, 04-749
Merz investigational site #048056 Recruiting
Warszawa, Poland, 02-097
Merz investigational site #048065 Recruiting
Warszawa, Poland, 00-453
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Director: Merz Medical Expert Merz Pharmaceuticals GmbH
  More Information

No publications provided

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT02091739     History of Changes
Other Study ID Numbers: MRZ60201_3090_1, 2012-005539-10
Study First Received: March 18, 2014
Last Updated: July 22, 2014
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Additional relevant MeSH terms:
Parkinson Disease
Sialorrhea
Stroke
Brain Injuries
Wounds and Injuries
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Craniocerebral Trauma
Trauma, Nervous System
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014