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Study on the Effectiveness and Safety of AC102 Injection vs. Oral Prednisolone for Patients with Sudden Hearing Loss

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Idiopathic Sudden Sensorineural Hearing Loss, which is a rapid loss of hearing that occurs without a known cause. The study is comparing two treatments: a single injection of a medication called AC102 into the middle ear and oral tablets of a steroid called Prednisolone. The purpose of the study is to evaluate how effective, safe, and tolerable these treatments are for patients experiencing sudden hearing loss.

Participants in the study will receive either the AC102 injection or the oral Prednisolone tablets. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will monitor changes in hearing ability over a period of time, specifically looking at improvements in hearing thresholds, which are the softest sounds a person can hear, and speech recognition, which is the ability to understand spoken words.

The study will take place over several weeks, with participants attending regular visits to assess their hearing progress. The main goal is to see if there is an improvement in hearing from the start of the study to the end, which is approximately 28 days after treatment begins. Additional assessments will be conducted up to 84 days to further evaluate the long-term effects of the treatments. This research aims to provide valuable insights into the best treatment options for those affected by sudden hearing loss.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a hearing test to measure the hearing threshold.

    The hearing test focuses on the three most affected frequencies between 0.25 and 8 kHz.

  2. Step 2

    Randomization and treatment allocation

    Participants are randomly assigned to one of two treatment groups: one receiving a single intratympanic injection of AC102-Suspension 12 mg/ml and the other receiving oral Prednisolon 10 mg GALEN® tablets.

    The intratympanic injection involves administering the medication directly into the middle ear.

  3. Step 3

    Medication administration

    For the group receiving AC102, a single dose is administered via injection into the middle ear.

    For the group receiving Prednisolon, the medication is taken orally in tablet form. The dosage and frequency are determined by the study protocol.

  4. Step 4

    Follow-up visits

    Participants attend follow-up visits to monitor progress and assess the treatment's effectiveness.

    Hearing tests are conducted at various intervals, specifically on Day 14, 28, 56, and 84, to measure changes in hearing thresholds and speech recognition.

  5. Step 5

    Final assessment

    A final assessment is conducted on Day 84 to evaluate the overall improvement in hearing and determine the need for any additional interventions, such as hearing aids or cochlear implants.

    The study concludes with a review of the participant's progress and any changes in hearing ability.

Who can join the trial?

12 criteria

  • Sign an approved informed consent form, which is a document that explains the study and confirms your agreement to participate.
  • Be a female or male aged between 18 and 85 years old on the day of screening.
  • Have **unilateral ISSNHL**, which means sudden hearing loss in one ear.
  • The sudden hearing loss must have started between 24 to 120 hours before being randomly assigned to a treatment group in the study.
  • Have a hearing threshold of at least 65 dB, which is a measure of hearing ability, in the affected ear.
  • Have a hearing loss of at least 30 dB compared to the unaffected ear, based on a hearing test.
  • Be willing and able to attend all trial visits.
  • Be able to read and understand trial documents and follow instructions during visits, including participating in hearing tests.
  • Female participants must either:
    • If able to have children, have a negative pregnancy test and agree to use a reliable birth control method for at least 30 days after the last study medication.
    • If unable to have children, be surgically sterile or postmenopausal (no periods for at least one year).
    • Male participants with partners who could become pregnant must either:
      • Be unable to father children, such as having had a vasectomy at least 6 months before screening.
      • Agree to use a reliable birth control method for at least 30 days after the last study medication.
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Investigated drugs

  • AC102

    is a medication being tested for its effectiveness in treating sudden hearing loss. It is given as a single dose directly into the ear. The study aims to see if this treatment can improve hearing in people who have experienced a sudden loss of hearing ability.

  • Oral Steroids

    are being used as a comparison treatment in the study. These are medications taken by mouth that help reduce inflammation and are commonly used to treat sudden hearing loss. The study will compare the effectiveness of oral steroids to the new treatment, AC102, in improving hearing.

What is already known about the treatment

AC102 – This medication is administered as a single intratympanic injection, meaning it is delivered directly into the middle ear. It is currently being studied in clinical trials for its effectiveness in treating idiopathic sudden sensorineural hearing loss (ISSNHL), a condition characterized by a rapid loss of hearing. The main therapeutic indication for AC102 is to improve hearing thresholds in affected patients. At the molecular level, AC102 is believed to work by reducing inflammation and protecting the inner ear cells, although the exact mechanism is still under investigation. It is classified pharmacologically as an investigational drug, as it is still undergoing research to determine its safety and efficacy compared to traditional oral steroids.

Investigated diseases

Idiopathic Sudden Sensorineural Hearing Loss – This condition is characterized by a rapid loss of hearing, typically in one ear, occurring over a period of 72 hours or less. The exact cause is unknown, which is why it is termed "idiopathic." It involves damage to the inner ear or the nerve pathways from the inner ear to the brain. Patients may experience a sudden drop in their ability to hear, often accompanied by a feeling of fullness in the ear, tinnitus, or dizziness. The progression can vary, with some individuals experiencing partial or full recovery over time, while others may have persistent hearing loss. The condition is considered a medical emergency, and early intervention is crucial for potential recovery.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513658-31-00Protocol codeAC102-201Estimated enrolment237 patientsSponsorAudioCure Pharma GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).