Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
|ClinicalTrials.gov Identifier: NCT01515371|
Recruitment Status : Terminated (Due to lack of sufficient eligible subjects, no safety concerns)
First Posted : January 24, 2012
Last Update Posted : June 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Habitual Snoring||Drug: IncobotulinumtoxinA Drug: Placebo Comparator||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||January 2012|
|Primary Completion Date :||September 2012|
|Study Completion Date :||November 2012|
Experimental: IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U
IncobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.
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.
Placebo Comparator: Placebo Comparator
Placebo to incobotulinumtoxinA (Xeomin) powder for solution for 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.
- Relative change from baseline in Snoring Index at week 4 [ Time Frame: Baseline to week 4 ]Snoring Index
- Absolute change from baseline in Snoring Index at week 4 [ Time Frame: Baseline to week 4 ]
- Bed partner satisfaction [ Time Frame: Week 4 ]Bed partner satisfaction to assess the global effect of the treatment.
- Change from baseline in loudness at week 4. [ Time Frame: Baseline to week 4 ]Sone is employed as the unit of the perceived loudness.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01515371
|Merz Investigational Site #049294|
|Regensburg, Germany, 93053|
|Study Chair:||Medical Expert||Merz Pharmaceuticals GmbH|