Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring
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|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|
|Actual Primary Completion Date :||September 2012|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|