Testing new therapy in treating Sudden Sensorineural Hearing Loss

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    What is this study about?

    The testing of a new drug, AC102, is underway in this study for individuals experiencing sudden, unexplained hearing loss, known as Idiopathic Sudden Sensorineural Hearing Loss. The study aims to compare the effectiveness of AC102 with the standard treatment, which involves oral steroid intake. Each patient will receive a single injection of AC102 into the eardrum. The study will evaluate the safety of AC102 and assess the improvement in hearing. After 28 days, the changes in hearing will be measured by testing the understanding of different sound levels.

    Learn more about this Trial

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      Locations

      Where does the clinical trial take place?

      Graz , Austria

      Linz , Austria

      Salzburg , Austria

      Wien , Austria

      Hradec Kru00e1lovu00e9 , Czechia

      Mladu00e1 Boleslav , Czechia

      Olomouc , Czechia

      Pardubice , Czechia

      Prague , Czechia

      Praha , Czechia

      Bad Schu00f6nborn , Germany

      Greifswald , Germany

      Gu00f6ttingen , Germany

      Halle (Saale) , Germany

      Heidelberg , Germany

      Heidelberg , Germany

      Jena , Germany

      Minden , Germany

      Suhl , Germany

      Nijmegen , Netherlands

      Nijmegen , Netherlands

      Uden , Netherlands

      Biau0142ystok , Poland

      Bydgoszcz , Poland

      Katowice , Poland

      Rzeszu00f3w , Poland

      Tarnowskie Gu00f3ry , Poland

      You can join this study in:

      Study Steps

      How Complex Will My Study Be and What Phases Will I Go Through?

      The steps a patient needs to take as part of the clinical trial are as follows:

      1. Single Intratympanic Injection: Patients will receive a single intratympanic injection of the drug AC102 gel if they are in the experimental arm group labeled “AC102.”
      2. Daily Oral Tablets: Patients in the AC102 arm group will also take placebo tablets daily by mouth.
      3. Prednisolone Tablets: Patients in the active comparator arm group labeled “Prednisolone” will take prednisolone tablets daily by mouth.
      4. Placebo Intratympanic Injection: Those in the Prednisolone arm group will also receive a single intratympanic injection of a placebo gel.

      These interventions are designed to study the change in pure tone audiometry (PTA) from baseline to day 28 and the absolute improvement of speech recognition between days 14, 28, 56, and 84 in comparison to baseline using standardized word lists.


      Diseases Under Investigation

      What Conditions Qualify Me for This Study?

      To join the study, you need to have the following disease:

      Unilateral Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL).

      The other conditions related to this disease that must be met are:

      1. Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization.
      2. An absolute air conduction hearing threshold of at least 65 dB.
      3. A relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear.

      Terms and conditions

      What Requirements I Have to Meet To Join This Study?

      When Am I Eligible to Join the Study?

      The conditions you must meet to join the study, along with explanations of medical terms, are as follows:

      1. Age: You must be a male or female patient aged between 18 and 85 years.
      2. Unilateral ISSNHL: This stands for Unilateral Idiopathic Sudden Sensorineural Hearing Loss. It means a sudden hearing loss in one ear without an identifiable cause.
      3. Onset of unilateral ISSNHL: The hearing loss must have occurred between 24 to 120 hours prior to being randomized in the study.
      4. Absolute air conduction hearing threshold: You must have an air conduction hearing threshold of at least 65 dB. An air conduction hearing threshold is a measure of the softest sounds you can hear through earphones in a quiet environment during a hearing test.
      5. Relative hearing loss: You must have experienced a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear. A relative hearing loss is the difference in hearing between your ears, and an audiogram is a chart that represents your hearing ability based on hearing tests.

      The inclusion criteria do not mention specific indexes or scales that require additional explanation beyond what was provided above.

      What Reasons Could Exclude Me from the Study?

      Here are the conditions under which you cannot take part in the study, along with explanations of the medical terms:

      1. Insufficient handling of the language used in the speech audiometry tests: You must be able to understand and respond to the language used during tests that measure your ability to hear and comprehend speech.
      2. Bilateral hearing loss: You cannot have hearing loss in both ears.
      3. Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time: You cannot have recent hearing loss caused by:
        • Noise trauma: Damage to the ear from exposure to loud noises.
        • Barotrauma: Injury to the ear because of a change in air or water pressure.
        • Head trauma: Injury to the head that may affect hearing.
      4. Congenital hearing loss: You cannot have hearing loss that was present at birth.
      5. Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB: You cannot have:
        • Conductive hearing loss: A problem in the outer or middle ear that prevents sound from passing to the inner ear.
        • Combined hearing loss: Both conductive and sensorineural (nerve-related) hearing loss.

        The hearing loss must not be determined by a Pure Tone Average (4PTA), which is an average of the hearing threshold levels at four frequencies, greater than 10 decibels.

      6. History of ISSNHL in the past 1 years in the affected ear: You cannot have had idiopathic sudden sensorineural hearing loss (ISSNHL) in the ear under study within the last year. ISSNHL is a rapid loss of hearing that occurs without a known cause.

      These criteria are based on the document provided.


      Investigational Medicinal Product

      What Products Are Being Used in This Study?

      The drugs involved in the study are:

      1. AC102 gel – This is an investigational drug administered as a single intratympanic injection. It is used as the main experimental treatment in the study, but the specific active substance is not directly mentioned in the document. The description suggests it’s a novel formulation given the name AC102 for this trial.
      2. Prednisolone – This is the active comparator in the trial. Prednisolone is a steroid medication used to treat various conditions, including inflammation and immune system disorders. It is being used as a tablet taken daily by mouth in the study.

      If you need a detailed description and the chemical composition of AC102, I will need to look further into the document. However, Prednisolone is a well-known substance, and no additional details were provided in the intervention description.

      Have the Medicinal Substances Used in the Trial Been Previously Studied in Medicine?

      The active substances participating in the clinical trial are:

      1. AC102 gel: The specifics about AC102 are not provided in the clinical trial documents. Therefore, it is unclear whether AC102 is already known to medicine and medical literature or if it is a new experimental substance that is being studied for the first time in this clinical trial.
      2. Prednisolone tablets: Prednisolone is a well-known medication in medicine and medical literature. It is a corticosteroid drug used to treat various inflammatory and autoimmune conditions, among other uses. It is often prescribed for allergies, asthma, and rheumatic disorders.

      Study ID

      CT-EU-00042046

      Recruitment status

      Recruting new patients

      Start of the trial

      2 years ago