A Phase 2 interventional study of AC102 gel and Prednisolone in Hearing Loss, Sensorineural, sponsored by AudioCure Pharma GmbH. Completed at 39 sites in 6 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by AudioCure Pharma GmbH · Phase 2, Interventional, and Treatment
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).
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's enrollment of 223 is above the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →This is the only study on the registry with AudioCure Pharma GmbH as lead sponsor.
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Exclusion Criteria:
AC102 gel and placebo tablets
Drug: AC102 gel · Other: Placebo Tablets
Placebo gel and prednisolone tablets
Drug: Prednisolone · Other: Placebo gel
Drug: AC102 Single intratympanic injection
Active comparator: Prednisolone Tablets taken daily by mouth
Placebo Tablets taken daily by mouth
Placebo Single intratympanic injection
Change in pure tone audiometry (PTA; dB)
Mean change in absolute hearing thresholds measured by PTA from baseline to Day 28
Time frame: 28 days
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
Time frame: 14, 28, 56, 84 days
Plan to share: Yes
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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