Efficacy and Safety of AC102 Compared to Steroids in Adults With Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Hearing Loss, Sensorineural

Intervention / Treatment
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* Drug: AC102 gel
* Drug: Prednisolone
* Other: Placebo Tablets
* Other: Placebo gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AC102<br>AC102 gel and placebo tablets | Drug: AC102 gel<br>* Drug: AC102 Single intratympanic injection<br>Other: Placebo Tablets<br>* Placebo Tablets taken daily by mouth<br>|
| Active Comparator: Prednisolone<br>Placebo gel and prednisolone tablets | Drug: Prednisolone<br>* Active comparator: Prednisolone Tablets taken daily by mouth<br>Other: Placebo gel<br>* Placebo Single intratympanic injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pure tone audiometry (PTA; dB) | Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28 | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 14, 28, 56, 84 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hearing Loss, Hearing impairment, Hearing Loss, Sensorineural, Ear Diseases, Otorhinolaryngologic Diseases, Hearing Loss, Unilateral, Intratympanic Administration, Restoration of Hearing Loss