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

Phase 2

Recruiting

• Conditions: Hearing Loss, Sensorineural
• Interventions: Drug: AC102 gel; Drug: Prednisolone; Other: Placebo Tablets; Other: Placebo gel

• Registration Number: NCT05776459
• Lead Sponsor: AudioCure Pharma GmbH

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-13
• Study First Submitted: 2023-03-03
• Study First Submitted QC: 2023-03-17
• Study First Posted: 2023-03-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AC102	AC102 gel	AC102 gel and placebo tablets
AC102	Placebo Tablets	AC102 gel and placebo tablets
Prednisolone	Prednisolone	Placebo gel and prednisolone tablets
Prednisolone	Placebo gel	Placebo gel and prednisolone tablets

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists	14, 28, 56, 84 days	Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined

Trial Locations

Locations (40)

Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz; 🇩🇪 Berlin, Germany

University Hospital Dresden 'Carl Gustav Carus' - HNO; 🇩🇪 Dresden, Germany

Evangelisches Krankenhaus - Universitätsklinik für HNO; 🇩🇪 Oldenburg, Germany

Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde; 🇩🇪 Regensburg, Germany

Universitätsklinikum HNO; 🇩🇪 Würzburg, Germany

Centrum Słuchu i Mowy Sp. z o.o.; 🇵🇱 Nadarzyn, Poland

Oddział Laryngologii; 🇵🇱 Opole, Poland

Uniwersytecki Szpital Kliniczny Nr 1; 🇵🇱 Szczecin, Poland

Centrum Zdrowia MDM; 🇵🇱 Warsaw, Poland

Trialmed; 🇵🇱 Warsaw, Poland

ALL-MED Cetrum Medyczne; 🇵🇱 Łódź, Poland

Military Medical Academy - ENT department; 🇷🇸 Belgrad, Serbia

Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council; 🇺🇦 Ivano-Frankivs'k, 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; 🇺🇦 Úzhgorod, Ukraine

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; 🇦🇹 Wien, Austria

Fakultní nemocnice Hradec Králové; 🇨🇿 Hradec Králové, Czechia

Zdravotnická zařízení Olomouc, ORL; 🇨🇿 Olomouc, Czechia

Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku; 🇨🇿 Pardubice, Czechia

Fakultní nemocnice v Motole; 🇨🇿 Praha, Czechia

Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie; 🇩🇪 Greifswald, Germany

Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie; 🇩🇪 Halle (Saale), Germany

HNO Praxis Heidelberg; 🇩🇪 Heidelberg, Germany

Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum; 🇩🇪 Jena, Germany

Johannes Weseling Clinic Minden; 🇩🇪 Minden, Germany

SRH Zentralklinikum Suhl GmbH; 🇩🇪 Suhl, Germany

Radboud University Medical Center; 🇳🇱 Nijmegen, Netherlands

Bernhoven Hospital; 🇳🇱 Uden, Netherlands

Centrum Medyczne Kwiatowa; 🇵🇱 Bydgoszcz, Poland

Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice; 🇵🇱 Katowice, Poland

Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie; 🇵🇱 Rzeszów, Poland

University Clinical Centre of Serbia; 🇷🇸 Belgrade, Serbia

Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"; 🇷🇸 Belgrade, Serbia

Clinical Hospital Centre Zvezdara; 🇷🇸 Belgrade, Serbia

Clinical-Hospital Center Zemun; 🇷🇸 Belgrade, Serbia