MedTrace Logo

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

NCT05776459 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-01-16

No results posted yet for this study

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

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

Sponsors & Collaborators

  • AudioCure Pharma GmbH

    lead INDUSTRY

Principal Investigators

  • Reimar Schlingensiepen, MD · AudioCure Pharma GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-13
Primary Completion
2026-02-28
Completion
2026-07-31

Countries

  • Austria
  • Czechia
  • Germany
  • Poland
  • Serbia
  • Ukraine

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05776459 on ClinicalTrials.gov