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NCT Number: NCT05776459

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

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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Hearing Loss, Sensorineural Ear Diseases Hearing Disorders Hearing Loss Hearing Loss, Unilateral Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AC102 gel

Drug

Drug: AC102 Single intratympanic injection

Prednisolone

Drug

Active comparator: Prednisolone Tablets taken daily by mouth

Placebo tablets

Other

Placebo Tablets taken daily by mouth

Placebo gel

Other

Placebo Single intratympanic injection

Primary outcomes

  1. 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

Secondary outcomes

  1. Absolute improvement of speech recognition measured in quiet compared to baseline using standardized word lists

    Time frame: 14, 28, 56, 84 days

    Scores between 0% to 100% correctly understood words at predefined sound pressure levels are determined

Sponsors and collaborators

Lead sponsor

AudioCure Pharma GmbH

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 20, 2023
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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