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

Phase 2

Terminated

• Conditions: Habitual Snoring
• Interventions: Drug: Placebo Comparator; Drug: IncobotulinumtoxinA

• Registration Number: NCT01515371
• Lead Sponsor: Merz Pharmaceuticals GmbH

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-24
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-18
• Last Update Posted: 2013-06-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	Placebo Comparator	Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.
IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U	IncobotulinumtoxinA	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.

Primary Outcome Measures

Name	Time	Method
Relative change from baseline in Snoring Index at week 4	Baseline to week 4	Snoring Index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Merz Investigational Site #049294; 🇩🇪 Regensburg, Germany