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Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
Sponsor: AudioCure Pharma GmbH
Summary
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).
Official title: Phase II, Multi-Center, Randomized, Blinded Study Evaluating the Efficacy, Safety and Tolerability of a Single Intratympanic Dose of AC102 Compared to Oral Steroids for the Treatment of Idiopathic Sudden Sensorineural Hearing Loss
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2022-10-13
Completion Date
2026-07-31
Last Updated
2026-01-16
Healthy Volunteers
No
Conditions
Interventions
AC102 gel
Drug: AC102 Single intratympanic injection
Prednisolone
Active comparator: Prednisolone Tablets taken daily by mouth
Placebo Tablets
Placebo Tablets taken daily by mouth
Placebo gel
Placebo Single intratympanic injection
Locations (39)
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Graz, Austria
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, Austria
Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, Austria
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
Vienna, Austria
Zdravotnická zařízení Olomouc, ORL
Olomouc, Czechia
Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku
Pardubice, Czechia
Fakultní nemocnice v Motole
Prague, Czechia
Heilig Geist Hospital
Bensheim, Germany
Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz
Berlin, Germany
Unfallkrankenhaus Berlin
Berlin, Germany
University Hospital Dresden 'Carl Gustav Carus' - HNO
Dresden, Germany
Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
Greifswald, Germany
Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
Halle, Germany
HNO-Praxis Eidelstedter Platz
Hamburg, Germany
Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum
Jena, Germany
Universitätsmedizin der Johannes Gutenberg Universität Mainz Hals-, Nasen-, Ohrenklinik und Poliklinik
Mainz, Germany
Johannes Weseling Clinic Minden
Minden, Germany
Klinikum rechts der Isar
München, Germany
Evangelisches Krankenhaus - Universitätsklinik für HNO
Oldenburg, Germany
Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde
Regensburg, Germany
SRH Zentralklinikum Suhl GmbH
Suhl, Germany
Universitätsklinikum HNO
Würzburg, Germany
Centrum Medyczne Kwiatowa
Bydgoszcz, Poland
Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice
Katowice, Poland
ALL-MED Cetrum Medyczne
Lodz, Poland
Oddział Laryngologii
Opole, Poland
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszów, Poland
Uniwersytecki Szpital Kliniczny Nr 1
Szczecin, Poland
Trialmed
Warsaw, Poland
University Clinical Centre of Serbia
Belgrade, Serbia
Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"
Belgrade, Serbia
Military Medical Academy - ENT department
Belgrade, Serbia
Clinical Hospital Centre Zvezdara
Belgrade, Serbia
Clinical-Hospital Center Zemun
Belgrade, Serbia
Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, Ukraine
Communal non-profit enterprise "Central city clinical hospital of Ivano-Frankivsk city council"
Ivano-Frankivsk, Ukraine
Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council
Kyiv, Ukraine
MC Universal Clinic Oberig of Kapytal LLC
Kyiv, Ukraine
LLC Clinic of Healthy Family Astramed
Uzhhorod, Ukraine