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

Habitual Snoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01515371
• Other study ID #: MRZ 60201-2069-1
• Secondary ID: 2011-001779-38
• Status: Terminated
• Phase: Phase 2
• First received: January 18, 2012
• Last updated: June 18, 2013
• Start date: January 2012
• Est. completion date: November 2012

Study information

• Verified date: June 2013
• Source: Merz Pharmaceuticals GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Habitual Snoring
• Snoring

Intervention

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
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.

Locations

Country	Name	City	State
Germany	Merz Investigational Site #049294	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
Merz Pharmaceuticals GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change from baseline in Snoring Index at week 4	Snoring Index	Baseline to week 4	No
Secondary	Absolute change from baseline in Snoring Index at week 4		Baseline to week 4	No
Secondary	Bed partner satisfaction	Bed partner satisfaction to assess the global effect of the treatment.	Week 4	No
Secondary	Change from baseline in loudness at week 4.	Sone is employed as the unit of the perceived loudness.	Baseline to week 4	No