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 - Snoring

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-001779-38-DE

Enrollment

Registered

2011-08-31

Start date

2011-11-30

Completion date

Unknown

Last updated

2013-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Habitual snoring MedDRA version: 14.0 Level: PT Classification code 10041235 Term: Snoring System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Trade Name: Xeomin Product Name: NT 201 Product Code: NT 201 Pharmaceutical Form: Powder for solution for injection CAS Number: 93384-43-1 Current Sponsor code: NT 101 Other descriptive name: Botulinu

Eligibility

Sex/Gender

All

Inclusion criteria

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 ;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

Exclusion criteria

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 ;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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this prospective, randomized, double-blind, placebo-controlled, parallel-group, 3-stage dose-finding study is to identify a safe and effective dose of NT 201 for unilateral injection into the soft palate for the treatment of habitual snoring. ;Secondary Objective: The secondary objective of this study is to evaluate the safety and efficacy of up to 3 different doses of NT 201 after single unilateral injection into the soft palate for the treatment of habitual snoring. ;Primary end point(s): Relative change from baseline in Snoring Index at week 4 after injection ;Timepoint(s) of evaluation of this end point: week 4 ;Main Objective: The primary objective of this prospective, randomized, double-blind, placebo-controlled, parallel-group, 3-stage dose-finding study is to identify a safe and effective dose of NT 201 for unilateral injection into the soft palate for the treatment of habitual snoring. ;Secondary Objective: The secondary objective of this study is to evaluate the safety and efficacy of up to 3 different doses of NT 201 after single unilateral injection into the soft palate for the treatment of habitual snoring. ;Primary end point(s): Relative change from baseline in Snoring Index at week 4 after injection ;Timepoint(s) of evaluation of this end point: week 4	—

Measure

Time frame

Main Objective: The primary objective of this prospective, randomized, double-blind, placebo-controlled, parallel-group, 3-stage dose-finding study is to identify a safe and effective dose of NT 201 for unilateral injection into the soft palate for the treatment of habitual snoring. ;Secondary Objective: The secondary objective of this study is to evaluate the safety and efficacy of up to 3 different doses of NT 201 after single unilateral injection into the soft palate for the treatment of habitual snoring. ;Primary end point(s): Relative change from baseline in Snoring Index at week 4 after injection ;Timepoint(s) of evaluation of this end point: week 4 ;Main Objective: The primary objective of this prospective, randomized, double-blind, placebo-controlled, parallel-group, 3-stage dose-finding study is to identify a safe and effective dose of NT 201 for unilateral injection into the soft palate for the treatment of habitual snoring. ;Secondary Objective: The secondary objective of this study is to evaluate the safety and efficacy of up to 3 different doses of NT 201 after single unilateral injection into the soft palate for the treatment of habitual snoring. ;Primary end point(s): Relative change from baseline in Snoring Index at week 4 after injection ;Timepoint(s) of evaluation of this end point: week 4

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Secondary

Measure	Time frame
Secondary end point(s): Absolute change from baseline in Snoring Index at week 4 after injection, Bed partner satisfaction, Change from baseline in loudness at week 4. ;Timepoint(s) of evaluation of this end point: week 4 ;Secondary end point(s): Absolute change from baseline in Snoring Index at week 4 after injection, Bed partner satisfaction, Change from baseline in loudness at week 4. ;Timepoint(s) of evaluation of this end point: week 4	—

Measure

Time frame

Secondary end point(s): Absolute change from baseline in Snoring Index at week 4 after injection, Bed partner satisfaction, Change from baseline in loudness at week 4. ;Timepoint(s) of evaluation of this end point: week 4 ;Secondary end point(s): Absolute change from baseline in Snoring Index at week 4 after injection, Bed partner satisfaction, Change from baseline in loudness at week 4. ;Timepoint(s) of evaluation of this end point: week 4

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Countries

Germany

Contacts

Public Contact; ;

Merz Pharmaceuticals GmbH;Merz Pharmaceuticals GmbH

clinicaltrials@merz.de;clinicaltrials@merz.de;

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026