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

A

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

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

Trial contacts and locations

40

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Central trial contact

Christin Galetzka

Data sourced from clinicaltrials.gov

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