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Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders — Snoring  

Sleep-Disordered Breathing Clinical Trial

Official title:
Effect of NT 201 (Botulinum Neurotoxin Type A Free of Complexing Proteins) on Sleep-related Breathing Disorders (Snoring Study)

Clinical Trial Summary

This proof-of-concept study is to assess the potential benefit of botulinum toxin for patients with sleep-related breathing disorders.

Clinical Trial Description

Mono-center, double-blind, 1:1 randomized, placebo-controlled trial 18 treated patients, 9 patients per group.

Patients will be randomly assigned to treatment with NT 201 or placebo in a ratio of 1:1. In addition, within each treatment group patients will be randomly assigned to injection into the left or right soft palate.

Primary variable:

Comparison of the ratio of snoring time over sleeping time (Snoring Index). Other secondary variables will be analysed. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00773591
Study type Interventional
Source Merz Pharmaceuticals GmbH
Contact
Status Withdrawn
Phase Phase 2
Start date March 2010
Completion date October 2010
View Details
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