Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
Primary Purpose
Habitual Snoring
Status
Terminated
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
IncobotulinumtoxinA
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Habitual Snoring
Eligibility 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
Sites / Locations
- Merz Investigational Site #049294
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U
Placebo Comparator
Arm Description
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.
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Outcomes
Primary Outcome Measures
Relative change from baseline in Snoring Index at week 4
Snoring Index
Secondary Outcome Measures
Absolute change from baseline in Snoring Index at week 4
Bed partner satisfaction
Bed partner satisfaction to assess the global effect of the treatment.
Change from baseline in loudness at week 4.
Sone is employed as the unit of the perceived loudness.
Full Information
NCT ID
NCT01515371
First Posted
January 18, 2012
Last Updated
June 18, 2013
Sponsor
Merz Pharmaceuticals GmbH
1. Study Identification
Unique Protocol Identification Number
NCT01515371
Brief Title
Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
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 Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of sufficient eligible subjects, no safety concerns
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merz Pharmaceuticals GmbH
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Habitual Snoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
Intervention Type
Drug
Intervention Name(s)
IncobotulinumtoxinA
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Intervention Description
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.
Primary Outcome Measure Information:
Title
Relative change from baseline in Snoring Index at week 4
Description
Snoring Index
Time Frame
Baseline to week 4
Secondary Outcome Measure Information:
Title
Absolute change from baseline in Snoring Index at week 4
Time Frame
Baseline to week 4
Title
Bed partner satisfaction
Description
Bed partner satisfaction to assess the global effect of the treatment.
Time Frame
Week 4
Title
Change from baseline in loudness at week 4.
Description
Sone is employed as the unit of the perceived loudness.
Time Frame
Baseline to week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Expert
Organizational Affiliation
Merz Pharmaceuticals GmbH
Official's Role
Study Chair
Facility Information:
Facility Name
Merz Investigational Site #049294
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
12. IPD Sharing Statement
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Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
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