NCT00773591

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

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

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Sleep-Disordered Breathing

Interventions

Type	Name	Description
DRUG	NT 201, a Botulinum neurotoxin type A, free of complexing proteins	NT 201: Solution for injection, one dose of 5 U will be administered. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge. Placebo: Solution for injection, Dose n.a.; identical injected volume as active study medication. Route Injection into the soft palate 1 cm dorsal to the junction with the hard palate and 1 cm medial to the alveolar ridge.

Timeline

• Start date: 2010-03-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2008-10-16
• Last updated: 2015-03-30