AM-111 in the Treatment of Acute Inner Ear Hearing Loss

NCT ID: NCT02561091

Last Updated: 2023-09-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 256 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2017-09-30

Brief Summary

The purpose of this research study is to test the effectiveness and safety of the study drug, AM-111. AM-111 is tested for the treatment of sudden sensorineural hearing loss where the cause is unknown.

Detailed Description

This phase III study is assessing the drug's safety and is aiming to demonstrate efficacy of intratympanic AM-111 injections in the treatment of severe to profound idiopathic sudden sensorineural hearing loss (ISSNHL). The active pharmaceutical ingredient of AM-111 is the 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.

Conditions

Hearing Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo gel for intratympanic use

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

AM-111 0.4 mg/ml

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

Group Type: EXPERIMENTAL

AM-111 0.4 mg/ml

Intervention Type: DRUG

AM-111 0.8 mg/ml

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

Group Type: EXPERIMENTAL

AM-111 0.8 mg/ml

Intervention Type: DRUG

Interventions

Placebo

Intervention Type: OTHER

AM-111 0.4 mg/ml

Intervention Type: DRUG

AM-111 0.8 mg/ml

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Unilateral ISSNHL with onset within 72 hours prior to study treatment;

2. Mean hearing threshold of equal to or worse than (≥) 60 dB averaged across the 3 most affected contiguous air conduction audiometric pure tone frequencies ("pure tone average", PTA);*

3. Mean hearing loss of equal to or worse than (≥) 40 dB averaged across the air conducted PTA frequencies compared with the unaffected contralateral ear or reference values from a pre-existing audiogram or ISO 7029;2000 norm values in case of asymmetric hearing prior to the ISSNHL incident;

4. Age ≥ 18 and ≤ 65 years on the day of screening;

Exclusion Criteria

1. Bilateral ISSNHL;

2. Acute hearing loss from noise trauma, barotrauma or head trauma;

3. History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in the affected ear;

4. History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;

5. History of acoustic neuroma or other retrocochlear damage in the affected ear;

6. History of otosclerosis in the affected ear;

7. Suspected perilymph fistula or membrane rupture in the affected ear;

8. Congenital hearing loss;

9. History of ISSNHL in the past 2 years;

10. Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Auris Medical AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Please check link to study webpage below for more study sites

Sofia, , Bulgaria

Countries

Bulgaria

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-002077-21/results

Link to Result entry in clinicaltrialsregister.eu

https://pubmed.ncbi.nlm.nih.gov/31083077/

Link to peer-reviewed publication of study

Other Identifiers

AM-111-CL-13-01

Identifier Type: -

Identifier Source: org_study_id