Clinical trial NCT02561091: AM-111 in the Treatment of Acute Inner Ear Hearing Loss
Official title: Efficacy and Safety of AM-111 in the Treatment of Acute Inner Ear Hearing Loss
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hearing Loss
Keywords: Deafness
Hearing Loss, Sensorineural
Ear Diseases
Hearing Disorders
Otorhinolaryngologic Diseases
Sensation Disorders
Signs and Symptoms
Hearing and Speech impairment
Hearing Loss, Unilateral
Lead sponsor: Auris Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-25
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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;

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.

Primary outcomes:
measure: Pure tone average (PTA; average of the hearing threshold of three contiguous most affected hearing frequencies in dB)
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Please check link to study webpage below for more study sites
Study officials:
References: