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Completed

NCT Number: NCT02091739

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

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.

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Key information

Conditions

Chronic Troublesome Sialorrhea Basal Ganglia Diseases Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Post-stroke Synucleinopathies Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Merz investigational site #049172, Bonn, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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):
  • A Drooling Severity and Frequency Scale [DSFS] sum score of at least 6 points and
  • A score of at least 2 points for each item of the DSFS and
  • 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.

Treatment and study plan

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).

Other names: Xeomin, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

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).

Other names: Xeomin, NT 201, Botulinum toxin type A (150 kiloDalton), free from complexing proteins

Placebo

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merz Pharmaceuticals GmbH

Industry

Registry information

Official study 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

Acronym: SIAXI

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 19, 2014
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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