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

• Sponsor: Auris Medical AG
• Information provided by (Responsible Party): Auris Medical, Inc. ( Auris Medical AG )

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hearing Loss	Other: Placebo; Drug: AM-111 0.4 mg/ml; Drug: AM-111 0.8 mg/ml	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	256 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
Study Start Date :	November 2015
Actual Primary Completion Date :	September 2017
Actual Study Completion Date :	September 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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;

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.

Contacts and Locations

Locations

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

Sponsors and Collaborators

Auris Medical AG

More Information

Additional Information:

Study webpage with information about study and participating sites 

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Responsible Party:	Auris Medical AG
ClinicalTrials.gov Identifier:	NCT02561091 History of Changes
Other Study ID Numbers:	AM-111-CL-13-01
First Posted:	September 25, 2015
Last Update Posted:	October 16, 2017
Last Verified:	August 2017

Keywords provided by Auris Medical, Inc. ( Auris Medical AG ):

Deafness; Hearing Loss, Sensorineural; Ear Diseases; Hearing Disorders; Otorhinolaryngologic Diseases	Sensation Disorders; Signs and Symptoms; Hearing and Speech impairment; Hearing Loss, Unilateral

Additional relevant MeSH terms:

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Hearing Loss; Deafness; Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases	Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms