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Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment (ASSENT)

A

Auris Medical

Status and phase

Terminated
Phase 3

Conditions

Hearing Loss, Idiopathic Sudden Sensorineural

Treatments

Drug: AM-111 0.8 mg/ml
Other: Placebo
Drug: AM-111 0.4 mg/ml

Study type

Interventional

Funder types

Industry

Identifiers

NCT02809118
AM-111-CL-15-01

Details and patient eligibility

About

The primary objective of the trial is the confirmation of the efficacy of AM-111 in the recovery of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL).

Full description

This is a Phase III, randomized, double-blind, placebo-controlled, parallel group, multi-center, efficacy and safety trial of AM-111 in the treatment of subjects suffering from severe to profound idiopathic sudden sensorineural hearing loss.

The active pharmaceutical ingredient of AM-111 is a JNK inhibitor (D-JNKI-1), a synthetic peptide consisting of 31 D-amino acids, which acts as a c-Jun N-terminal kinase (JNK) ligand.

The study consists of one treatment visit and a follow-up period until day 91.

Study participants will receive, after topical anesthesia of the tympanic membrane, AM-111 0.4 mg/mL or 0.8 mg/mL or placebo, administered into the affected ear. Following the administration, subjects will rest in a supine or reclined position for 30 minutes. Study participants will have the option for a course of oral corticosteroids.

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
  2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across those 3 contiguous air conduction audiometric pure tone frequencies that show the highest mean hearing loss compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a pre-existing audiogram for the affected ear not older than 2 years prior to the ISSNHL incident (defined as "pure tone average", PTA);
  3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conduction thresholds at the pure tone average frequencies compared with the unaffected contralateral ear or, in case of history of asymmetric hearing, corresponding values from a preexisting audiogram for the affected ear not older than 2 years prior to the ISSNHL incident;
  4. Age ≥ 18 years on the day of screening;

Exclusion criteria

  1. Bilateral ISSNHL;
  2. Acute hearing loss from noise trauma, barotrauma or head trauma;
  3. Air-bone gap greater than 20 dB at the average of 3 contiguous test frequencies below 4 kHz, when the air-bone gap is measurable;
  4. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
  5. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
  6. Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
  7. History of otosclerosis in the affected ear;
  8. Suspected perilymph fistula or membrane rupture in the affected ear;
  9. Congenital hearing loss;
  10. History of ISSNHL in the past 2 years;
  11. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

56 participants in 3 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo gel for intratympanic use
Treatment:
Other: Placebo
AM-111 0.4 mg/ml
Experimental group
Description:
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
Treatment:
Drug: AM-111 0.4 mg/ml
AM-111 0.8 mg/ml
Experimental group
Description:
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
Treatment:
Drug: AM-111 0.8 mg/ml

Trial documents
2

Trial contacts and locations

51

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Data sourced from clinicaltrials.gov

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