Hearing Loss, SensorineuralPhase 2NCT05776459
Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)
A Phase 2 study testing AC102 gel and Prednisolone in people with Hearing Loss, Sensorineural, run by AudioCure Pharma GmbH at 39 sites in 6 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hearing Loss, Sensorineural
- What is being tested?
- AC102 gel and Prednisolone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 223 participants
- Where
- 39 sitesin 6 countries
- Study dates
- 13 Oct 2022to 15 Jan 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
39 sites in 6 countries.
39 sites in 6 countries
Germany15 sites
Heilig Geist Hospital
Bensheim, 64625
Klinik für Hals-, Nasen-, Ohrenheilkunde - Charité Campus Benjamin Franklin - HNO Hochschulambulanz
Berlin, 10117
Unfallkrankenhaus Berlin
Berlin, 12683
University Hospital Dresden 'Carl Gustav Carus' - HNO
Dresden, 01307
Klinik und Poliklinik für Hals-, Nasen-, Ohrenkrankheiten, Kopf- und Halschirurgie
Greifswald, 17475
Universitätsklinik und Poliklinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
Halle, 06120
HNO-Praxis Eidelstedter Platz
Hamburg, 22523
Klinik für Hals-, Nasen- und Ohrenheilkunde am Universitätsklinikum
Jena, 07747
Universitätsmedizin der Johannes Gutenberg Universität Mainz Hals-, Nasen-, Ohrenklinik und Poliklinik
Mainz, 51131
Johannes Weseling Clinic Minden
Minden, 32429
Klinikum rechts der Isar
München, 81675
Evangelisches Krankenhaus - Universitätsklinik für HNO
Oldenburg, 26122
Universitätsklinikum Regensburg - Klinik für HNO-Heilkunde
Regensburg, 93053
SRH Zentralklinikum Suhl GmbH
Suhl, 98527
Universitätsklinikum HNO
Würzburg, 97080
Poland7 sites
Centrum Medyczne Kwiatowa
Bydgoszcz, 85-047
Centrum Medyczne MAVIT - Szpital Specjalistyczny Katowice
Katowice, 40-431
ALL-MED Cetrum Medyczne
Lodz, 94-046
Oddział Laryngologii
Opole, 45-418
Kliniczny Szpital Wojewódzki Nr 1 im. Fryderyka Chopina w Rzeszowie
Rzeszów, 35-055
Uniwersytecki Szpital Kliniczny Nr 1
Szczecin, 71-252
Trialmed
Warsaw, 02-482
Serbia5 sites
University Clinical Centre of Serbia
Belgrade, 11000
Clinical Hospital Centar "dr Dragisa Misovic-Dedinje"
Belgrade, 11040
Military Medical Academy - ENT department
Belgrade, 11040
Clinical Hospital Centre Zvezdara
Belgrade, 11050
Clinical-Hospital Center Zemun
Belgrade, 11080
Ukraine5 sites
Municipal non-profit enterprise Regional Clinical Hospital of Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76000
Communal non-profit enterprise "Central city clinical hospital of Ivano-Frankivsk city council"
Ivano-Frankivsk, 76018
Municipal non-profit enterprise Oleksandrivska clinical hospital of Kyiv of the executive body of Kyiv city council
Kyiv, 01601
MC Universal Clinic Oberig of Kapytal LLC
Kyiv, 03057
LLC Clinic of Healthy Family Astramed
Uzhhorod, 88000
Austria4 sites
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Graz, 8036
Ordensklinikum Linz GmbH Barmherzige Schwestern
Linz, 4010
Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
Salzburg, 5020
Universitätsklinik für Hals-, Nasen- und Ohrenkrankheiten
Vienna, 1090
Czechia3 sites
Zdravotnická zařízení Olomouc, ORL
Olomouc, 779 00
Pardubická nemocnice, Klinika ORL a chirurgie hlavy a krku
Pardubice, 532 03
Fakultní nemocnice v Motole
Prague, 150 06
About this study
Official title: 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).
- Conditions
- Hearing Loss, Sensorineural
- Being tested
- AC102 gel, Prednisolone, Placebo Tablets, Placebo gel
- Keywords
- Hearing Loss, Hearing impairment, Hearing Loss, Sensorineural, Ear Diseases, Otorhinolaryngologic Diseases, Hearing Loss, Unilateral, Intratympanic Administration, Restoration of Hearing Loss
- Medical subject headings
- Hearing Loss, Sensorineural, Hearing Loss, Ear Diseases, Otorhinolaryngologic Diseases, Hearing Loss, Unilateral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC102 gelDrug
Drug: AC102 Single intratympanic injection
PrednisoloneDrug
Active comparator: Prednisolone Tablets taken daily by mouth
Placebo TabletsOther
Placebo Tablets taken daily by mouth
Placebo gelOther
Placebo Single intratympanic injection
| Study group | Role | What they receive |
|---|---|---|
| AC102 | Experimental | AC102 gel and placebo tablets Receives: Drug: AC102 gel; Other: Placebo Tablets |
| Prednisolone | Active comparator | Placebo gel and prednisolone tablets Receives: Drug: Prednisolone; Other: Placebo gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pure tone audiometry (PTA; dB)
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28
Measured: 28 days
Secondary outcomes (1)
Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists
Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined
Measured: 14, 28, 56, 84 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start13 Oct 2022
- Primary completion18 Nov 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing Loss, SensorineuralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- AudioCure Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Reimar Schlingensiepen, MD, Study director, AudioCure Pharma GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776459
- Sponsor's protocol ID
- AC102-201
- Status last verified
- Nov 2026
- First submitted
- 3 Mar 2023
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05776459
- Acronym / sponsor ID
- AC102-201
- Conditions
- Hearing Loss, Sensorineural
- Keywords
- Hearing Loss, Hearing impairment, Hearing Loss, Sensorineural, Ear Diseases, Otorhinolaryngologic Diseases, Hearing Loss, Unilateral, Intratympanic Administration, Restoration of Hearing Loss
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- AudioCure Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 18 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 20 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AC102 | Experimental | Drug: AC102 gel, Other: Placebo TabletsAC102 gel and placebo tablets |
| Prednisolone | Active comparator | Drug: Prednisolone, Other: Placebo gelPlacebo gel and prednisolone tablets |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC102 gelDrug: AC102 Single intratympanic injection | Drug | AC102 |
| PrednisoloneActive comparator: Prednisolone Tablets taken daily by mouth | Drug | Prednisolone |
| Placebo TabletsPlacebo Tablets taken daily by mouth | Other | AC102 |
| Placebo gelPlacebo Single intratympanic injection | Other | Prednisolone |
Primary outcome
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
1 secondary outcome
Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists
Time frame: 14, 28, 56, 84 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes
Related trials for Hearing Loss, Sensorineural
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
RecruitingObservational study
Retrospectively Investigating Longitudinal Outcomes in MED-EL SONATA 2 Cochlear Implant Recipients.
Cochlear Implantation, Sensorineural Hearing Loss
Enrolling by invitationObservational study
Post-Market Registry Study for Vibrant Hearing Solutions
Conductive Hearing Loss, Mixed Hearing Loss
Enrolling by invitationObservational study
Long Term Follow-up Study of AAVAnc80-hOTOF Gene Therapy
Otoferlin Gene-mediated Hearing Loss
Active, not recruiting
Performance of a Remote Microphone Compared to Hearing Aids Alone
Hearing Loss, Bilateral Sensorineural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reimar Schlingensiepen, MD study director
AudioCure Pharma GmbH
39 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AC102 gel and Prednisolone in people with Hearing Loss, Sensorineural, run by AudioCure Pharma GmbH at 39 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Germany, Poland, Serbia, Ukraine, Austria and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pure tone audiometry (PTA; dB) (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.