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

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

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.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Other: Placebo; Drug: AM-111 0.4 mg/ml; Drug: AM-111 0.8 mg/ml

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.

• Study Type: Interventional
• Enrollment (Actual): 256
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Please check link to study webpage below for more study sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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;

Other protocol-defined inclusion criteria may apply.

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;

Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo gel for intratympanic use	Other: Placebo
Experimental: AM-111 0.4 mg/ml; AM-111 gel for intratympanic use (0.4 mg/ml AM-111)	Drug: AM-111 0.4 mg/ml
Experimental: AM-111 0.8 mg/ml; AM-111 gel for intratympanic use (0.8 mg/ml AM-111)	Drug: AM-111 0.8 mg/ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB)	Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from D0 to D28	Day 28

Collaborators and Investigators

• Sponsor: Auris Medical AG

Publications and helpful links

Helpful Links

• Link to Result entry in clinicaltrialsregister.eu
• Link to peer-reviewed publication of study

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: September 23, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimated): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Signs and Symptoms; Deafness; Hearing Loss, Sensorineural; Ear Diseases; Hearing Disorders; Otorhinolaryngologic Diseases; Sensation Disorders; Hearing and Speech impairment; Hearing Loss, Unilateral
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Sensorineural
• Other Study ID Numbers: AM-111-CL-13-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No