Dose finding study for a Botulinum toxin type A injection to treat habitual snoring

• Conditions: Habitual snoring; MedDRA version: 14.0Level: PTClassification code 10041235Term: SnoringSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2011-001779-38-DE
• Lead Sponsor: Merz Pharmaceuticals GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08-31
• Last Update Posted: 24 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 48

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 V2
-Subjects with a bed partner for at least the last three months prior to study start
-Subjects who understand the nature of the study and provide written Informed Consent [IC] at screening visit V1.
-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
;
-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 V2
-Subjects with a bed partner for at least the last three months prior to study start
-Subjects who understand the nature of the study and provide written Informed Consent [IC] at screening visit V1.
-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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Obese subjects (Body Mass Index = 30)
-Subjects with severe obstructive sleep apnea syndrome [OSAS]
-Subjects with Apnea-Hypopnea Index [AHI] = 10 /hour of sleep and/ or Respiratory Disturbance Index [RDI] = 25 / hour of sleep at the baseline visit V2
-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

;
-Obese subjects (Body Mass Index = 30)
-Subjects with severe obstructive sleep apnea syndrome [OSAS]
-Subjects with Apnea-Hypopnea Index [AHI] = 10 /hour of sleep and/ or Respiratory Disturbance Index [RDI] = 25 / hour of sleep at the baseline visit V2
-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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified