NCT05776459

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

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: AudioCure Pharma GmbH · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Hearing Loss, Sensorineural

Interventions

Type	Name	Description
DRUG	AC102 gel	Drug: AC102 Single intratympanic injection
DRUG	Prednisolone	Active comparator: Prednisolone Tablets taken daily by mouth
OTHER	Placebo Tablets	Placebo Tablets taken daily by mouth
OTHER	Placebo gel	Placebo Single intratympanic injection

Timeline

• Start date: 2022-10-13
• Primary completion: 2026-02-28
• Completion: 2026-07-31
• First posted: 2023-03-20
• Last updated: 2026-01-16

Locations

39 sites across 6 countries: Austria, Czechia, Germany, Poland, Serbia, Ukraine