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

AudioCure Pharma GmbH0 sites210 target enrollmentDecember 7, 2021

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: last year

No summary available.

Registry

who.int

Start Date

December 7, 2021

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•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 current audiogram of the non\-affected ear (average of the three most affected consecutive frequencies between 0\.25 and 8 kHz).
•7\. Willing and able to use adequate hearing protection and to refrain from engaging in activities or work involving loud noise exposure where sufficient hearing protection is not possible or ensured for the duration of their participation in this study
•8\. Able to read and understand trial documents and follow Investigator and trial personnel instructions during visits. Willing and able to comply with procedures of audiological assessments (in particular pure tone audiometry and speech audiometry)
•9\.Female patients must meet one of the following criteria:
•o If of childbearing potential – have a negative urine pregnancy test and agree to use a highly effective medically accepted contraceptive method for at least 30 days after the last study medication intake

•1\. Insufficient handling of the language used in the speech audiometry tests
•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, tympanogram type can be used (other than A).
•6\. Suspected perilymph fistula or round window membrane rupture in either ear
•7\. Otitis media or otitis externa that is ongoing or ended within 30 days prior to randomization or is occurring several times per year
•8\. Patients with abnormality of the tympanic membrane or the outer ear canal that would preclude intratympanic administration
•9\. Evidence or history of vestibular schwannoma (acoustic neuroma) or other retrocochlear damage in the affected ear