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

Conditions

Idiopathic Sudden Sensorineural Hearing Loss

Brief summary

Mean change in absolute hearing thresholds (average of the three most affected consecutive frequencies from 0.25 to 8 kHz) measured by PTA from baseline to Day 28

Detailed description

Absolute improvement of speech recognition from baseline to Day 84, Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz), Percentage of patients with complete, partial or no remission on Day 28, 56 and 84 (no recovery: ≤ 10 dB, complete: within 10 dB to the contralateral ear), Percentage of patients qualifying for a hearing aid or a cochlear implant at Day 84, Absolute improvement of speech recognition in quiet from baseline to Day 14, 28 and 56, Percentage of patients eligible for salvage therapy, Improvement of scoring in HHIA from baseline to Day 28 and 84, Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 28, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz) in patients with a baseline hearing threshold of ≥80 dB

Related papers

No related papers found yet.

Interventions

DRUGAC102-Suspension 12 mg/ml

DRUGplacebo gel

DRUGPlacebo matching Prednisolone

DRUGPrednisolon 10 mg GALEN®

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean change in absolute hearing thresholds (average of the three most affected consecutive frequencies from 0.25 to 8 kHz) measured by PTA from baseline to Day 28	—

Secondary

Measure	Time frame
Absolute improvement of speech recognition from baseline to Day 84, Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz), Percentage of patients with complete, partial or no remission on Day 28, 56 and 84 (no recovery: ≤ 10 dB, complete: within 10 dB to the contralateral ear), Percentage of patients qualifying for a hearing aid or a cochlear implant at Day 84, Absolute improvement of speech recognition in quiet from baseline to Day 14, 28 and 56, Percentage of patients eligible for salvage therapy, Improvement of scoring in HHIA from baseline to Day 28 and 84, Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 28, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz) in patients with a baseline hearing threshold of ≥80 dB	—

Measure

Time frame

Absolute improvement of speech recognition from baseline to Day 84, Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz), Percentage of patients with complete, partial or no remission on Day 28, 56 and 84 (no recovery: ≤ 10 dB, complete: within 10 dB to the contralateral ear), Percentage of patients qualifying for a hearing aid or a cochlear implant at Day 84, Absolute improvement of speech recognition in quiet from baseline to Day 14, 28 and 56, Percentage of patients eligible for salvage therapy, Improvement of scoring in HHIA from baseline to Day 28 and 84, Mean change in absolute hearing thresholds of PTA from baseline to Day 14, 28, 56 and 84 at the three mostly affected consecutive frequencies and mean change of 4PTA (PTA at the frequencies 0.5, 1, 2, and 4 kHz) in patients with a baseline hearing threshold of ≥80 dB

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Countries

Austria, Czechia, Germany, Netherlands, Poland

Outcome results

None listed