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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Habitual Snoring

Intervention / Treatment
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* Drug: IncobotulinumtoxinA
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U<br>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<br>* 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.<br>|
| Placebo Comparator: Placebo Comparator<br>Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. | Drug: Placebo Comparator<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change from baseline in Snoring Index at week 4 | Snoring Index | Baseline to week 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in Snoring Index at week 4 |  | Baseline to week 4 | 
| Bed partner satisfaction | Bed partner satisfaction to assess the global effect of the treatment. | Week 4 | 
| Change from baseline in loudness at week 4. | Sone is employed as the unit of the perceived loudness. | Baseline to week 4 |