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

AudioCure Pharma

Status and phase: Enrolling; Phase 2

Conditions: Hearing Loss, Sensorineural

Treatments: Drug: AC102 gel; Other: Placebo gel; Drug: Prednisolone; Other: Placebo Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT05776459

AC102-201

Details and patient eligibility

About

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).

Enrollment: 210 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients aged between 18 and 85 years
• Unilateral ISSNHL
• Onset of unilateral ISSNHL between 24 to 120 hours prior to randomization
• An absolute air conduction hearing threshold of at least 65 dB,
• Patients with a relative hearing loss of at least 30 dB compared to the current audiogram of the non-affected ear

Exclusion criteria

• Insufficient handling of the language used in the speech audiometry tests
• Bilateral hearing loss
• Acute hearing loss from noise trauma, barotrauma or head trauma in either ear at any time
• Congenital hearing loss
• Conductive hearing loss or combined hearing loss determined by a 4PTA > 10 dB
• History of ISSNHL in the past 1 years in the affected ear

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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210 participants in 2 patient groups

AC102

Experimental group

Description:

AC102 gel and placebo tablets

Treatment:

Other: Placebo Tablets

Drug: AC102 gel

Prednisolone

Active Comparator group

Description:

Placebo gel and prednisolone tablets

Treatment:

Other: Placebo gel

Drug: Prednisolone