NCT01515371 - Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

September 30, 2012

Study Completion Date

November 30, 2012

Conditions

Habitual Snoring

Interventions

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.

Trial Locations (1)

93053

Merz Investigational Site #049294, Regensburg