Status:
TERMINATED
Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
Lead Sponsor:
Merz Pharmaceuticals GmbH
Conditions:
Habitual Snoring
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01515371
Start Date
January 1 2012
End Date
November 1 2012
Last Update
June 19 2013
Active Locations (1)
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1
Merz Investigational Site #049294
Regensburg, Germany, 93053