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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001779-38 | EudraCT Number |
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Due to lack of sufficient eligible subjects, no safety concerns
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IncobotulinumtoxinA (Xeomin) 2.5 Units [U], 5U and 7.4U | Experimental | 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. |
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| Placebo Comparator | Placebo Comparator | Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IncobotulinumtoxinA | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline in Snoring Index at week 4 | Snoring Index | Baseline to week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute change from baseline in Snoring Index at week 4 | Baseline to week 4 | |
| Bed partner satisfaction | Bed partner satisfaction to assess the global effect of the treatment. | Week 4 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Expert | Merz Pharmaceuticals GmbH | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merz Investigational Site #049294 | Regensburg | 93053 | Germany |
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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| Placebo Comparator | Drug | 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. |
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| Change from baseline in loudness at week 4. | Sone is employed as the unit of the perceived loudness. | Baseline to week 4 |