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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 16, 2026 (before its estimated February 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 40 to 39
    • Primary completion date: Dec 31, 2025 to Feb 28, 2026
    • Study completion date: Dec 31, 2025 to Jul 31, 2026
    v6
  2. Primary completion date: Oct 30, 2024 to Dec 31, 2025
    • Study sites: 31 to 40
    • Study completion date: Dec 30, 2024 to Dec 31, 2025
    v5
  3. Study sites: 32 to 31
    • Eligibility criteria shortened, about 1 word
    v4
  4. Study sites: 1 to 32v3
  5. Secondary endpoints: details revised at 1 of 1 entryv2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05776459
Lead Sponsor AudioCure Pharma GmbH
Conditions
(from sponsor)		 Hearing Loss, Sensorineural
Related terms Ear Diseases, Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Unilateral, Otorhinolaryngologic Diseases
Enrollment 210 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov