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The purpose of this Phase 2 clinical trial is to evaluate the safety, tolerability and efficacy of AC102 administered as single intratympanic injection compared to oral steroid treatment in patients with Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AC102 | Experimental | AC102 gel and placebo tablets |
|
| Prednisolone | Active Comparator | Placebo gel and prednisolone tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AC102 gel | Drug | Drug: AC102 Single intratympanic injection |
| |
| Prednisolone |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pure tone audiometry (PTA; dB) | Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28 | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists | Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined | 14, 28, 56, 84 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reimar Schlingensiepen, MD | AudioCure Pharma GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde | Graz | 8036 | Austria | |||
| Ordensklinikum Linz GmbH Barmherzige Schwestern |
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| Drug |
Active comparator: Prednisolone Tablets taken daily by mouth |
|
| Placebo Tablets | Other | Placebo Tablets taken daily by mouth |
|
| Placebo gel | Other | Placebo Single intratympanic injection |
|
| Linz |
| 4010 |
| Austria |
| Universitätsklinik für Hals-Nasen-Ohren-Krankheiten | Salzburg | 5020 | Austria |
| Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten | Vienna | 1090 | Austria |
| Zdravotnická zařízení Olomouc, ORL | Olomouc | 779 00 | Czechia |
| Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku | Pardubice | 532 03 | Czechia |
| Fakultní nemocnice v Motole | Prague | 150 06 | Czechia |
| Heilig Geist Hospital | Bensheim | 64625 | Germany |
| Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz | Berlin | 10117 | Germany |
| Unfallkrankenhaus Berlin | Berlin | 12683 | Germany |
| University Hospital Dresden 'Carl Gustav Carus' - HNO | Dresden | 01307 | Germany |
| Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie | Greifswald | 17475 | Germany |
| Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie | Halle | 06120 | Germany |
| HNO-Praxis Eidelstedter Platz | Hamburg | 22523 | Germany |
| Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum | Jena | 07747 | Germany |
| Universitätsmedizin der Johannes Gutenberg Universität Mainz Hals-, Nasen-, Ohrenklinik und Poliklinik | Mainz | 51131 | Germany |
| Johannes Weseling Clinic Minden | Minden | 32429 | Germany |
| Klinikum rechts der Isar | München | 81675 | Germany |
| Evangelisches Krankenhaus - Universitätsklinik für HNO | Oldenburg | 26122 | Germany |
| Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde | Regensburg | 93053 | Germany |
| SRH Zentralklinikum Suhl GmbH | Suhl | 98527 | Germany |
| Universitätsklinikum HNO | Würzburg | 97080 | Germany |
| Centrum Medyczne Kwiatowa | Bydgoszcz | 85-047 | Poland |
| Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice | Katowice | 40-431 | Poland |
| ALL-MED Cetrum Medyczne | Lodz | 94-046 | Poland |
| Oddział Laryngologii | Opole | 45-418 | Poland |
| Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie | Rzeszów | 35-055 | Poland |
| Uniwersytecki Szpital Kliniczny Nr 1 | Szczecin | 71-252 | Poland |
| Trialmed | Warsaw | 02-482 | Poland |
| University Clinical Centre of Serbia | Belgrade | 11000 | Serbia |
| Clinical Hospital Centar "dr Dragisa Misovic-Dedinje" | Belgrade | 11040 | Serbia |
| Military Medical Academy - ENT department | Belgrade | 11040 | Serbia |
| Clinical Hospital Centre Zvezdara | Belgrade | 11050 | Serbia |
| Clinical-Hospital Center Zemun | Belgrade | 11080 | Serbia |
| Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council | Ivano-Frankivsk | 76000 | Ukraine |
| Communal non-profit enterprise "Central city clinical hospital of Ivano-Frankivsk city council" | Ivano-Frankivsk | 76018 | Ukraine |
| Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council | Kyiv | 01601 | Ukraine |
| MC Universal Clinic Oberig of Kapytal LLC | Kyiv | 03057 | Ukraine |
| LLC Clinic of Healthy Family Astramed | Uzhhorod | 88000 | Ukraine |
| ID | Term |
|---|---|
| D006319 | Hearing Loss, Sensorineural |
| D034381 | Hearing Loss |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D046088 | Hearing Loss, Unilateral |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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