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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
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.
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.
Merz Investigational Site #049294
Regensburg, Germany
Relative change from baseline in Snoring Index at week 4
Snoring Index
Time frame: Baseline to week 4
Absolute change from baseline in Snoring Index at week 4
Time frame: Baseline to week 4
Bed partner satisfaction
Bed partner satisfaction to assess the global effect of the treatment.
Time frame: Week 4
Change from baseline in loudness at week 4.
Sone is employed as the unit of the perceived loudness.
Time frame: Baseline to week 4
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