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Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-Related Breathing Disorders (Snoring)
This study is not yet open for participant recruitment.
Verified by Merz Pharmaceuticals GmbH, October 2008
Sponsored by: Merz Pharmaceuticals GmbH
Information provided by: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00773591
  Purpose

This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.


Condition Intervention Phase
Sleep-Disordered Breathing
Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins
Phase II

MedlinePlus related topics: Snoring
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-Related Breathing Disorders (Snoring Study)

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Comparison of the ratio of snoring time over sleeping time (Snoring Index) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in ventilation (oral/nasal flow) from V0 to V2 and from V0 to V3 including: → Peakflow Vmax → Tidal volume (Vt) [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: November 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Botulinum Toxin Typ A: Active Comparator Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins
Placebo: Placebo Comparator Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins

Detailed Description:

Mono-center, double-blind, 1:1 randomized, placebo-controlled trial 18 treated patients, 9 patients per group.

Patients will be randomly assigned to treatment with NT 201 or placebo in a ratio of 1:1. In addition, within each treatment group patients will be randomly assigned to injection into the left or right soft palate.

Primary variable:

Comparison of the ratio of snoring time over sleeping time (Snoring Index). Other secondary variables will be analysed.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female outpatients of at least 18 years of age.
  2. Patient who understand the nature of the study and provide written informed consent prior to protocol-specific procedures.
  3. Patients suffering from sleep-related breathing disorders for at least 3 months prior to study start and seeking help for their snoring.
  4. Non-REM RDI ≤ 25/h (according to Medicare Criteria) at baseline PSG.
  5. AHI ≤ 10/h at baseline PSG.
  6. Snoring Index ≥ 15 at baseline PSG.

Exclusion Criteria:

  1. Patients with known hypersensitivity to:

    • botulinum neurotoxin type;
    • any of the excipients (human albumin, sucrose).
  2. Patients with upper respiratory tract pathology as assessed by an ear, nose, and throat [ENT] specialist.
  3. Patients with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome).
  4. Patients with bleeding disorders of any type and/or receiving anticoagulant therapy.
  5. Patients with a profound sleep disorder (pathological number and duration of episodes of hypopnea and apnea), upper airway resistance syndrome [UARS], or obstructive sleep apnea syndrome [OSAS].
  6. Obese patients (BMI ≥ 30).
  7. Presence of concomitant diseases:

    • severe or unstable cardiovascular (e.g. severe angina pectoris, post myocardial infarction and ventricular extra systoles), pulmonary, or endocrine disease; clinically relevant renal or hepatic disease or dysfunction; hematological disorder; any other clinically relevant medical condition that could increase the risk to the study participant;
    • malignant disease of any kind during the previous 5 years except for successfully treated skin (basal or squamous cell) cancer;
    • amyotrophic lateral sclerosis or other diseases which result in peripheral neuromuscular dysfunction;
    • risk of developing an angle closure glaucoma;
    • alcohol, drug, or medication abuse within the past year;
    • severe psychiatric or neurological disorders;
    • acute infections of the pharynx.
  8. Patients likely to need concomitant medication as follows:

    • 4-aminochinolines;
    • aminoglycosides or spectinomycin, or other medical products interfering with neuromuscular transmission, e.g. tubocurarine-type muscle relaxants;
    • daily psychotropic medication;
    • regular intake or onset of hypnotics, e.g. benzodiazepines, chloralhydrate and combinations, barbiturates (except of mild phytotherapeutics, e.g. valerian, hop and combinations);
    • anti-snoring products during the course of the study such as foams, dental devices.
  9. Pregnant or nursing women, or women of childbearing potential who are not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, unless they are surgically sterilized/ hysterectomized.
  10. Participation in a clinical study within the last 30 days prior to the start of the study.
  11. Patients who are employees, relative or spouse of the investigator, of other staff of the investigational site or the sponsor or the CRO.
  12. Any donation of germ cells, blood, organs, or bone marrow during the course of the study.
  13. Patients who are expected to be non-compliant and/or not cooperative.
  14. Patients who are not contractually capable.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00773591

Contacts
Contact: Nicole Albala +49/(0)69/1503- ext 1409 nicole.albala@merz.de
Contact: Christine Kliebe-Frisch, PhD +49/(0)69/1503- ext 868 Christine.Kliebe@merz.de

Locations
Germany, Nordrhein-Westfalen
Somnolab Dortmund, Christian Guilleminault Schlaflabor
Dortmund, Nordrhein-Westfalen, Germany, D-44263
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
  More Information

Responsible Party: Merz Pharmaceuticals GmbH ( Nicole Albala, Study Manager )
Study ID Numbers: MRZ 60201 SB_2001
Study First Received: October 15, 2008
Last Updated: October 15, 2008
ClinicalTrials.gov Identifier: NCT00773591  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merz Pharmaceuticals GmbH:
Sleep-related breathing disorders
Snoring

Study placed in the following topic categories:
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Snoring
Dyssomnias
Sleep Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on January 14, 2009