Clinical trial NCT02809118: Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Official title: Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hearing Loss, Idiopathic Sudden Sensorineural
Keywords: 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
Lead sponsor: Auris Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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;

Primary outcomes:
measure: Pure Tone Average (PTA)
timeFrame: Day 0 and Day 91: The study was prematurely terminated.
Secondary outcomes:
measure: Word Recognition Score (WRS) - Main Secondary
timeFrame: Day 0 and Day 91: The study was prematurely terminated.
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Escondido
country: United States
state: California
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: New Haven
country: United States
state: Connecticut
city: Boca Raton
country: United States
state: Florida
city: Boynton Beach
country: United States
state: Florida
city: Celebration
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Port Saint Lucie
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Des Moines
country: United States
state: Iowa
city: Kansas City
country: United States
state: Kansas
city: Louisville
country: United States
state: Kentucky
city: Novi
country: United States
state: Michigan
city: Columbia
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Charlotte
country: United States
state: New York
city: New Hyde Park
country: United States
state: New York
city: New Windsor
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: White Plains
country: United States
state: New York
city: Matthews
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Havertown
country: United States
state: Pennsylvania
city: Philadelphia
country: United States
state: Pennsylvania
city: Charleston
country: United States
state: South Carolina
city: Lugoff
country: United States
state: South Carolina
city: Orangeburg
country: United States
state: South Carolina
city: Nashville
country: United States
state: Tennessee
city: Fort Sam Houston
country: United States
state: Texas
city: Saint George
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Norfolk
country: United States
state: Virginia
city: Tacoma
country: United States
state: Washington
city: Kelowna
country: Canada
state: British Columbia
city: Penticton
country: Canada
state: British Columbia
city: Markham
country: Canada
state: Ontario
city: Seongnam
country: Korea, Republic of
state: Gyeonggi
city: Suwon
country: Korea, Republic of
state: Gyeonggi
city: Incheon
country: Korea, Republic of
state: Jung-Gu
city: Gwangju
country: Korea, Republic of
city: Pusan
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Auris Medical, Inc.
name: Thomas Meier
role: STUDY_DIRECTOR
References: