Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
NCT ID: NCT01515371
Last Updated: 2013-06-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
8 participants
INTERVENTIONAL
2012-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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 to incobotulinumtoxinA (Xeomin) powder for solution for 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Merz Pharmaceuticals GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Expert
Role: STUDY_CHAIR
Merz Pharmaceuticals GmbH
Locations
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Merz Investigational Site #049294
Regensburg, , Germany
Countries
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Other Identifiers
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2011-001779-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MRZ 60201-2069-1
Identifier Type: -
Identifier Source: org_study_id
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