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

Study Description

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Brief Summary:

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).

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

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	56 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 as Acute Sudden Sensorineural Hearing Loss Treatment
Study Start Date :	June 2016
Actual Primary Completion Date :	February 2018
Actual Study Completion Date :	February 2018

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; Placebo gel for intratympanic use	Other: Placebo; Placebo gel is administered with a single dose into the affected ear after topical anesthesia
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; AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
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; AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia

Outcome Measures

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Primary Outcome Measures :

1. Pure tone average (PTA; average of the hearing threshold of the three contiguous most affected hearing frequencies) [ Time Frame: Day 91 ]
   Assessment with pure tone audiometry/ Measurement at 8 frequencies/ Final outcome is the absolute improvement in PTA from Day 0 to Day 91

Secondary Outcome Measures :

1. Word recognition score (WRS) - main secondary [ Time Frame: Day 91 ]
   Absolute improvement in WRS (80dB) from baseline to Day 91

Eligibility Criteria

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

Criteria

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;

Contacts and Locations

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Sponsors and Collaborators

Auris Medical, Inc.

More Information

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Additional Information:

Study webpage with information on study and sites participating 

Responsible Party:	Auris Medical, Inc.
ClinicalTrials.gov Identifier:	NCT02809118 History of Changes
Other Study ID Numbers:	AM-111-CL-15-01
First Posted:	June 22, 2016
Last Update Posted:	April 19, 2018
Last Verified:	September 2017

Keywords provided by Auris Medical, Inc.:

Deafness; Hearing Loss; Hearing Loss, Sensorineural; Ear Diseases; Hearing Disorders; Nervous System Diseases	Neurologic Manifestations; 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