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

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

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.

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