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Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring

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ClinicalTrials.gov Identifier: NCT01515371
Recruitment Status : Terminated (Due to lack of sufficient eligible subjects, no safety concerns)
First Posted : January 24, 2012
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to identify out of up to three doses a safe and effective dose of Botulinum toxin type A for an injection into one side of the soft palate to treat snoring.

Condition or disease Intervention/treatment Phase
Habitual Snoring Drug: IncobotulinumtoxinA Drug: Placebo Comparator Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Prospective, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-stage Dose-finding Study to Identify a Safe and Effective Dose of NT 201 for Unilateral Injection Into the Soft Palate for Treatment of Habitual Snoring
Study Start Date : January 2012
Primary Completion Date : September 2012
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U
IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
Drug: IncobotulinumtoxinA

Subject to receive one injection of either 2.5U, 5U or 7.4U of IncobotulinumtoxinA.

For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per 50U vial, respectively, resulting in a concentration of 6.25 U/ml, 12.5 U/ml and 18.5 U/ml. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.

Placebo Comparator: Placebo Comparator
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Drug: Placebo Comparator
For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per vial, respectively. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.


Outcome Measures

Primary Outcome Measures :
  1. Relative change from baseline in Snoring Index at week 4 [ Time Frame: Baseline to week 4 ]
    Snoring Index


Secondary Outcome Measures :
  1. Absolute change from baseline in Snoring Index at week 4 [ Time Frame: Baseline to week 4 ]
  2. Bed partner satisfaction [ Time Frame: Week 4 ]
    Bed partner satisfaction to assess the global effect of the treatment.

  3. Change from baseline in loudness at week 4. [ Time Frame: Baseline to week 4 ]
    Sone is employed as the unit of the perceived loudness.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female or male subjects aged 18-70
  • Subjects suffering from snoring for at least 3 months prior to the study start and seeking for help to treat snoring
  • Subjects with a peak Snoring Index [SI] ≥ 15/ hour of sleep [h] at baseline visit
  • Subjects with a bed partner for at least three months prior to study start.
  • Subjects who understand the nature of the study and provide written Informed Consent at screening visit.
  • Subjects who understand the study procedures as well as possess the ability and willingness to abide by all procedures during the course of the study

Exclusion Criteria:

  • Obese subjects (Body Mass Index ≥ 30)
  • Subjects with severe obstructive sleep apnea syndrome
  • Subjects with Apnea-Hypopnea Index ≥ 10 /hour of sleep and/ or Respiratory Disturbance Index ≥ 25 / hour of sleep at the baseline visit
  • Subjects who have undergone any Botulinum neurotoxin treatment in the history
  • Subjects with generalized disorders of muscle activity (e.g. myasthenia gravis, Lambert-Eaton syndrome)
  • Acute infections of the pharynx
Contacts and Locations

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): NCT01515371


Locations
Germany
Merz Investigational Site #049294
Regensburg, Germany, 93053
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Chair: Medical Expert Merz Pharmaceuticals GmbH
More Information

Responsible Party: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT01515371     History of Changes
Other Study ID Numbers: MRZ 60201-2069-1
2011-001779-38 ( EudraCT Number )
First Posted: January 24, 2012    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Pharmaceutical Solutions
Botulinum Toxins
Botulinum Toxins, Type A
onabotulinumtoxinA
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