EUCTR2021-004323-33-AT
Active, not recruiting
Phase 1
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
ConditionsIdiopathic Sudden Sensorineural Hearing Loss (ISSNHL)ISSNHL is most commonly defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring within a 72-hr period.Inclusion within this trial applies for moderately severe to profound cases ( 65 to <100 dB) within 24 to 120 hours after onset.Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Idiopathic Sudden Sensorineural Hearing Loss (ISSNHL)ISSNHL is most commonly defined as sensorineural hearing loss of 30dB or greater over at least three contiguous audiometric frequencies occurring within a 72-hr period.Inclusion within this trial applies for moderately severe to profound cases ( 65 to <100 dB) within 24 to 120 hours after onset.
- Sponsor
- AudioCure Pharma GmbH
- Enrollment
- 210
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed Institutional Review Board (IRB) / Independent Ethics
- •Committee (IEC) approved informed consent form (ICF)
- •2\. Female or male patients aged between 18 and 85 years (inclusive) at
- •the day of Screening
- •3\. Unilateral ISSNHL
- •4\. Onset of unilateral ISSNHL between 24 to 120 hours prior to
- •randomization
- •5\. Patients with an absolute air conduction hearing threshold of at least 65 dB, but less than 100 dB (average of the three most affected
- •consecutive frequencies between 0\.25 and 8 kHz)
- •6\. Patients with a relative hearing loss of at least 30 dB compared to the
Exclusion Criteria
- •1\. Insufficient handling of the language used in the speech audiometry
- •a) Bilateral hearing loss
- •b) Sudden hearing loss in the only hearing ear (i.e. pre\-existing hearing
- •loss in the contralateral ear of 40 dB or more measured by PTA in the
- •range of 0\.5\-4 kHz)
- •3\. Acute hearing loss from noise trauma, barotrauma or head trauma in
- •either ear at any time
- •4\. Congenital hearing loss
- •5\. Conductive hearing loss or combined hearing loss determined by a
- •4PTA \> 10 dB. Only if the limit for bone conduction is reached,
Outcomes
Primary Outcomes
Not specified
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