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One shot to restore hearing? new drug takes on steroids

NCT ID NCT05776459

Disease control Sponsor: AudioCure Pharma GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single injection of a new drug called AC102 into the ear, comparing it to standard steroid pills for sudden hearing loss. About 210 adults with hearing loss in one ear will take part. The goal is to see if the injection improves hearing better than steroids, with fewer side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Jul 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Ear Diseases hearing loss disorder Hearing Loss, Sensorineural Hearing Loss, Unilateral otorhinolaryngologic disease sensorineural hearing loss disorder sudden sensorineural hearing loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hearing loss, sensorineural

Contacts and locations

Locations

  • ALL-MED Cetrum Medyczne

    Lodz, 94-046, Poland

  • Centrum Medyczne Kwiatowa

    Bydgoszcz, 85-047, Poland

  • Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice

    Katowice, 40-431, Poland

  • Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"

    Belgrade, 11040, Serbia

  • Clinical Hospital Centre Zvezdara

    Belgrade, 11050, Serbia

  • Clinical-Hospital Center Zemun

    Belgrade, 11080, Serbia

  • Communal non-profit enterprise "Central city clinical hospital of Ivano-Frankivsk city council"

    Ivano-Frankivsk, 76018, Ukraine

  • Evangelisches Krankenhaus - Universitätsklinik für HNO

    Oldenburg, 26122, Germany

  • Fakultní nemocnice v Motole

    Prague, 150 06, Czechia

  • HNO-Praxis Eidelstedter Platz

    Hamburg, 22523, Germany

  • Heilig Geist Hospital

    Bensheim, 64625, Germany

  • Johannes Weseling Clinic Minden

    Minden, 32429, Germany

  • Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie

    Rzeszów, 35-055, Poland

  • Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum

    Jena, 07747, Germany

  • Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz

    Berlin, 10117, Germany

  • Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie

    Greifswald, 17475, Germany

  • Klinikum rechts der Isar

    München, 81675, Germany

  • LLC Clinic of Healthy Family Astramed

    Uzhhorod, 88000, Ukraine

  • MC Universal Clinic Oberig of Kapytal LLC

    Kyiv, 03057, Ukraine

  • Military Medical Academy - ENT department

    Belgrade, 11040, Serbia

  • Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council

    Kyiv, 01601, Ukraine

  • Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76000, Ukraine

  • Oddział Laryngologii

    Opole, 45-418, Poland

  • Ordensklinikum Linz GmbH Barmherzige Schwestern

    Linz, 4010, Austria

  • Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku

    Pardubice, 532 03, Czechia

  • SRH Zentralklinikum Suhl GmbH

    Suhl, 98527, Germany

  • Trialmed

    Warsaw, 02-482, Poland

  • Unfallkrankenhaus Berlin

    Berlin, 12683, Germany

  • University Clinical Centre of Serbia

    Belgrade, 11000, Serbia

  • University Hospital Dresden 'Carl Gustav Carus' - HNO

    Dresden, 01307, Germany

  • Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde

    Graz, 8036, Austria

  • Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten

    Vienna, 1090, Austria

  • Universitätsklinik für Hals-Nasen-Ohren-Krankheiten

    Salzburg, 5020, Austria

  • Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie

    Halle, 06120, Germany

  • Universitätsklinikum HNO

    Würzburg, 97080, Germany

  • Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde

    Regensburg, 93053, Germany

  • Universitätsmedizin der Johannes Gutenberg Universität Mainz Hals-, Nasen-, Ohrenklinik und Poliklinik

    Mainz, 51131, Germany

  • Uniwersytecki Szpital Kliniczny Nr 1

    Szczecin, 71-252, Poland

  • Zdravotnická zařízení Olomouc, ORL

    Olomouc, 779 00, Czechia

More trials for these conditions

Other studies related to the condition(s) this trial covers.