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.

Study Overview

• Status: Terminated
• Conditions: Habitual Snoring
• Intervention / Treatment: Drug: IncobotulinumtoxinA; Drug: Placebo Comparator

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 2

Contacts and Locations

Study Locations

• Germany
  • Regensburg, Germany, 93053
    • Merz Investigational Site #049294

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Merz Pharmaceuticals GmbH
• Investigators: Study Chair: Medical Expert, Merz Pharmaceuticals GmbH

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (Estimate): January 24, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2013
• Last Update Submitted That Met QC Criteria: June 18, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Agents; Membrane Transport Modulators; Acetylcholine Release Inhibitors; Neuromuscular Agents; incobotulinumtoxinA
• Other Study ID Numbers: MRZ 60201-2069-1; 2011-001779-38 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No