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

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merz Pharmaceuticals GmbH
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA; Pharmaceutical Solutions

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