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

Sponsor

Merz Pharmaceuticals GmbH (Industry)

Overall Status

Terminated

CT.gov ID

NCT01515371

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Habitual Snoring	Drug: IncobotulinumtoxinA Drug: Placebo Comparator	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

8 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Relative change from baseline in Snoring Index at week 4 [Baseline to week 4]
Snoring Index

Secondary Outcome Measures

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.
Change from baseline in loudness at week 4. [Baseline to week 4]
Sone is employed as the unit of the perceived loudness.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Merz Investigational Site #049294	Regensburg		Germany	93053

Sponsors and Collaborators

Merz Pharmaceuticals GmbH

Investigators

Study Chair: Medical Expert, Merz Pharmaceuticals GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Merz Pharmaceuticals GmbH

ClinicalTrials.gov Identifier:

NCT01515371

Other Study ID Numbers:

MRZ 60201-2069-1
2011-001779-38

First Posted:

Jan 24, 2012

Last Update Posted:

Jun 19, 2013

Last Verified:

Jun 1, 2013

Additional relevant MeSH terms:

Snoring

incobotulinumtoxinA

Study Results

No Results Posted as of Jun 19, 2013