NCT01515371

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Merz Pharmaceuticals GmbH · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Habitual Snoring

Interventions

Type	Name	Description
DRUG	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.
DRUG	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.

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-09-01
• Completion: 2012-11-01
• First posted: 2012-01-24
• Last updated: 2013-06-19

Locations

1 site across 1 country: Germany