Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
Phase 2
Terminated
- Conditions
- Habitual Snoring
- Interventions
- Drug: Placebo Comparator
- 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
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.
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie IncobotulinumtoxinA's effect on soft palate muscles in habitual snoring?
How does unilateral IncobotulinumtoxinA injection compare to bilateral approaches in snoring treatment efficacy?
Are there specific biomarkers that predict response to Botulinum toxin type A in obstructive sleep apnea patients?
What are the long-term safety profiles of Botulinum toxin type A injections for snoring management?
How does IncobotulinumtoxinA compare to standard-of-care treatments like CPAP in snoring reduction effectiveness?
Trial Locations
- Locations (1)
Merz Investigational Site #049294
🇩🇪Regensburg, Germany
Merz Investigational Site #049294🇩🇪Regensburg, Germany