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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany
Nemocnice Pardubickeho kraje a.s. Pardubice Czechia
HNO Ärzte im Ostend GbR Hildesheim Germany
Medical University Of Vienna Vienna Austria
University Hospital Jena KöR Jena Germany
University Medicine Greifswald Greifswald Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Universitaetsklinikum Heidelberg AöR Heidelberg Germany
Medical University Of Graz Graz Austria

Other Sites

Site Name City Country Status
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Klinikum Ernst von Bergmann gGmbH Potsdam Germany
Johannes Wesling Klinikum Minden Minden Germany
Bernhoven B.V. Uden The Netherlands
BG Klinikum Unfallkrankenhaus Berlin gGmbH Berlin Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Universitaetsklinikum Regensburg AöR Regensburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Uniklinikum Salzburg Salzburg Austria
Evangelische Krankenhausstiftung Oldenburg Oldenburg In Holstein Germany
Centrum Zdrowia MDM Warsaw Poland
Praxis Dres. Med. Florian Heimlich Und Angelika Witzel-Heimlich GbR Heidelberg Germany
Universitätsklinikum Freiburg Freiburg Im Breisgau Germany
Ogshorfuzzfswr Llav Gbyn Linz Austria
Mtoemmuskgtftclsvjbjebetsi Hzewztpqhbxvonig Halle (Saale) Germany
Sxz Znwzistzluebqjl Swec Gxaf Suhl Germany
Ofzipwsm Pgwjw Nhilsaav Oztqtrr Olomouc Czechia
Skoaqco Swgfneeptggfwll Cpdbtyq Mpdhrtkmte Mblly Katowice Poland
Ctefoal Sbhocj i Mdzk Mgttswix Nadarzyn Poland
Cbbeyxn Mumnbqpy Kyvldsxs Bydgoszcz Poland
Hii Effovpgltk Hamburg Germany
Hjwgvbwwkbbl Hznotkxc Buwwhlcz Bensheim Germany
Ekbfibtnfryr Gvyc Essen Germany
Typdgdow Sin z opwy Piotrkow Trybunalski Poland
Fsuuzcqu nldjmdxaz Mcypc a Hraexnt Prague Czechia
Sqnoxeddo Rmiukot Uvksrvcdux Megrkka Cdjsru Nijmegen The Netherlands
Uuffkbzdgpjxpuqspvjfq Wudkkscwv Ama Wuerzburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
13.10.2022
Czechia Czechia
Not recruiting
13.10.2022
Germany Germany
Not recruiting
13.10.2022
Poland Poland
Not recruiting
13.10.2022
The Netherlands The Netherlands
Not recruiting
13.10.2022

Trial locations

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.

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 ID:
2024-513658-31-00
Protocol code:
AC102-201
NCT ID:
NCT05776459
Trial Phase:
Therapeutic exploratory (Phase II)

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