Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
NCT ID: NCT05776459
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
210 participants
INTERVENTIONAL
2022-10-13
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AC102
AC102 gel and placebo tablets
AC102 gel
Drug: AC102 Single intratympanic injection
Placebo Tablets
Placebo Tablets taken daily by mouth
Prednisolone
Placebo gel and prednisolone tablets
Prednisolone
Active comparator: Prednisolone Tablets taken daily by mouth
Placebo gel
Placebo Single intratympanic injection
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Unilateral ISSNHL
* Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
* An absolute air conduction hearing threshold of at least 65 dB,
* Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear
Exclusion Criteria
* Bilateral hearing loss
* Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
* Congenital hearing loss
* Conductive hearing loss or combined hearing loss determined by a 4PTA \> 10 dB
* History of ISSNHL in the past 1 years in the affected ear
18 Years
85 Years
ALL
No
Sponsors
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AudioCure Pharma GmbH
INDUSTRY
Responsible Party
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Principal Investigators
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Reimar Schlingensiepen, MD
Role: STUDY_DIRECTOR
AudioCure Pharma GmbH
Locations
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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
Countries
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Other Identifiers
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AC102-201
Identifier Type: -
Identifier Source: org_study_id
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