Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
NCT ID: NCT02809118
Last Updated: 2020-08-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
56 participants
INTERVENTIONAL
2016-06-30
2018-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo gel for intratympanic use
Placebo
Placebo gel is administered with a single dose into the affected ear after topical anesthesia
AM-111 0.4 mg/ml
AM-111 gel for intratympanic use (0.4 mg/ml AM-111)
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
AM-111 0.8 mg/ml
AM-111 gel for intratympanic use (0.8 mg/ml AM-111)
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
Interventions
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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
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
Placebo
Placebo gel is administered with a single dose into the affected ear after topical anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
ALL
No
Sponsors
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Auris Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Thomas Meier
Role: STUDY_DIRECTOR
Auris Medical, Inc.
Locations
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Birmingham, Alabama, United States
Escondido, California, United States
Fresno, California, United States
La Jolla, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Celebration, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Port Saint Lucie, Florida, United States
Chicago, Illinois, United States
Des Moines, Iowa, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
Novi, Michigan, United States
Columbia, Missouri, United States
Lebanon, New Hampshire, United States
Charlotte, New York, United States
New Hyde Park, New York, United States
New Windsor, New York, United States
New York, New York, United States
Rochester, New York, United States
White Plains, New York, United States
Matthews, North Carolina, United States
Winston-Salem, North Carolina, United States
Havertown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Lugoff, South Carolina, United States
Orangeburg, South Carolina, United States
Nashville, Tennessee, United States
Fort Sam Houston, Texas, United States
Salt Lake City, Utah, United States
St. George, Utah, United States
Norfolk, Virginia, United States
Tacoma, Washington, United States
Kelowna, British Columbia, Canada
Penticton, British Columbia, Canada
Markham, Ontario, Canada
Seongnam-si, Gyeonggi-do, South Korea
Suwon, Gyeonggi-do, South Korea
Incheon, Jung-Gu, South Korea
Gwangju, , South Korea
Pusan, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AM-111-CL-15-01
Identifier Type: -
Identifier Source: org_study_id
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