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

January 15, 2026 updated by: AudioCure Pharma GmbH

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
      • Linz, Austria, 4010
        • Ordensklinikum Linz GmbH Barmherzige Schwestern
      • Salzburg, Austria, 5020
        • Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
      • Vienna, Austria, 1090
        • Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
  • Czechia
      • Olomouc, Czechia, 779 00
        • Zdravotnická zařízení Olomouc, ORL
      • Pardubice, Czechia, 532 03
        • Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku
      • Prague, Czechia, 150 06
        • Fakultni nemocnice v Motole
  • Germany
      • Bensheim, Germany, 64625
        • Heilig Geist Hospital
      • Berlin, Germany, 12683
        • Unfallkrankenhaus Berlin
      • Berlin, Germany, 10117
        • Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz
      • Dresden, Germany, 01307
        • University Hospital Dresden 'Carl Gustav Carus' - HNO
      • Greifswald, Germany, 17475
        • Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
      • Halle, Germany, 06120
        • Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
      • Hamburg, Germany, 22523
        • HNO-Praxis Eidelstedter Platz
      • Jena, Germany, 07747
        • Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum
      • Mainz, Germany, 51131
        • Universitätsmedizin der Johannes Gutenberg Universität Mainz Hals-, Nasen-, Ohrenklinik und Poliklinik
      • Minden, Germany, 32429
        • Johannes Weseling Clinic Minden
      • München, Germany, 81675
        • Klinikum Rechts der Isar
      • Oldenburg, Germany, 26122
        • Evangelisches Krankenhaus - Universitätsklinik für HNO
      • Regensburg, Germany, 93053
        • Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde
      • Suhl, Germany, 98527
        • SRH Zentralklinikum Suhl GmbH
      • Würzburg, Germany, 97080
        • Universitätsklinikum HNO
  • Poland
      • Bydgoszcz, Poland, 85-047
        • Centrum Medyczne Kwiatowa
      • Katowice, Poland, 40-431
        • Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice
      • Lodz, Poland, 94-046
        • ALL-MED Cetrum Medyczne
      • Opole, Poland, 45-418
        • Oddział Laryngologii
      • Rzeszów, Poland, 35-055
        • Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie
      • Szczecin, Poland, 71-252
        • Uniwersytecki Szpital Kliniczny Nr 1
      • Warsaw, Poland, 02-482
        • TrialMed
  • Serbia
      • Belgrade, Serbia, 11000
        • University Clinical Centre of Serbia
      • Belgrade, Serbia, 11040
        • Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"
      • Belgrade, Serbia, 11040
        • Military Medical Academy - ENT department
      • Belgrade, Serbia, 11050
        • Clinical Hospital Centre Zvezdara
      • Belgrade, Serbia, 11080
        • Clinical-Hospital Center Zemun
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76000
        • Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
      • Ivano-Frankivsk, Ukraine, 76018
        • Communal non-profit enterprise "Central city clinical hospital of Ivano-Frankivsk city council"
      • Kyiv, Ukraine, 01601
        • Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council
      • Kyiv, Ukraine, 03057
        • MC Universal Clinic Oberig of Kapytal LLC
      • Uzhhorod, Ukraine, 88000
        • LLC Clinic of Healthy Family Astramed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AC102
AC102 gel and placebo tablets
Drug: AC102 gel
Drug: AC102 Single intratympanic injection
Other: Placebo Tablets
Placebo Tablets taken daily by mouth
Active Comparator: Prednisolone
Placebo gel and prednisolone tablets
Drug: Prednisolone
Active comparator: Prednisolone Tablets taken daily by mouth
Other: Placebo gel
Placebo Single intratympanic injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pure tone audiometry (PTA; dB)
Time Frame: 28 days
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28
28 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AudioCure Pharma GmbH

Investigators

  • Study Director: Reimar Schlingensiepen, MD, AudioCure Pharma GmbH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2022

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 20, 2023

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 15, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC102-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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