Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

NCT05776459 · tracked via the Priya Life Science Austria tracker

Sponsor

AudioCure Pharma GmbH

Phase

Phase 2

Started

2022-10-13

Last updated

2026-01-16

Condition(s) studied

Hearing Loss, Sensorineural

Investigational drug(s) / intervention(s)

AC102 gelPrednisolone →Placebo TabletsPlacebo gel

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

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

85 Years

Healthy volunteers

Inclusion Criteria: * Male or female patients aged between 18 and 85 years * 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: * Insufficient handling of the language used in the speech audiometry tests * 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

Primary outcome measure(s)

Change in pure tone audiometry (PTA; dB) — 28 days
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28

Trial sites (39)

Facility	City	Region
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

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05776459 on ClinicalTrials.gov ↗ ← All trials in Austria