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

• ClinicalTrials.gov Identifier: NCT02561091
• Recruitment Status: Completed
• First Posted: September 25, 2015
• Last Update Posted: October 16, 2017
• 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

• 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

• 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

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 

• Responsible Party: Auris Medical AG
• ClinicalTrials.gov Identifier: NCT02561091
• 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:

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