Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders (Snoring)

This study has been withdrawn prior to enrollment.
(The BfArM (CA)approved the trial in Nov 2008. However, the responsible EC refused approval in March 2009.)
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00773591
First received: October 15, 2008
Last updated: August 9, 2010
Last verified: August 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders (Snoring Study)

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Comparison of the ratio of snoring time over sleeping time (Snoring Index) [ Time Frame: Snoring Index measured from baseline to follow-up visit and to V3. ] [ 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) [ Time Frame: Change in several Secondary variables from baseline over time ] [ Designated as safety issue: No ]

Estimated Enrollment: 18
Study Start Date: March 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Botulinum Toxin Typ A Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins

NT 201: Solution for injection, one dose of 5 U will be administered. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge.

Placebo: Solution for injection, Dose n.a.; identical injected volume as active study medication. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge.

Placebo Comparator: Placebo Drug: NT 201, a Botulinum neurotoxin type A, free of complexing proteins

NT 201: Solution for injection, one dose of 5 U will be administered. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge.

Placebo: Solution for injection, Dose n.a.; identical injected volume as active study medication. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge.


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
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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Nicole Albala, Study Manager, Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00773591     History of Changes
Other Study ID Numbers: MRZ 60201 SB_2001
Study First Received: October 15, 2008
Last Updated: August 9, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Respiratory Aspiration
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Botulinum Toxins, Type A
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014