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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02809118
Recruitment Status : Terminated (Availability of relevant new efficacy data from another study)
First Posted : June 22, 2016
Last Update Posted : April 19, 2018
Sponsor:
Information provided by (Responsible Party):
Auris Medical, Inc.

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

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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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02809118


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, California
Escondido, California, United States
Fresno, California, United States
La Jolla, California, United States
United States, Colorado
Aurora, Colorado, United States
United States, Connecticut
New Haven, Connecticut, United States
United States, Florida
Boca Raton, Florida, United States
Boynton Beach, Florida, United States
Celebration, Florida, United States
Miami, Florida, United States
Port Saint Lucie, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Iowa
Des Moines, Iowa, United States
United States, Kansas
Kansas City, Kansas, United States
United States, Kentucky
Louisville, Kentucky, United States
United States, Michigan
Novi, Michigan, United States
United States, Missouri
Columbia, Missouri, United States
United States, New Hampshire
Lebanon, New Hampshire, United States
United States, New York
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
United States, North Carolina
Matthews, North Carolina, United States
Winston-Salem, North Carolina, United States
United States, Pennsylvania
Havertown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charleston, South Carolina, United States
Lugoff, South Carolina, United States
Orangeburg, South Carolina, United States
United States, Tennessee
Nashville, Tennessee, United States
United States, Texas
Fort Sam Houston, Texas, United States
United States, Utah
Saint George, Utah, United States
Salt Lake City, Utah, United States
United States, Virginia
Norfolk, Virginia, United States
United States, Washington
Tacoma, Washington, United States
Canada, British Columbia
Kelowna, British Columbia, Canada
Penticton, British Columbia, Canada
Canada, Ontario
Markham, Ontario, Canada
Korea, Republic of
Seongnam, Gyeonggi, Korea, Republic of
Suwon, Gyeonggi, Korea, Republic of
Incheon, Jung-Gu, Korea, Republic of
Gwangju, Korea, Republic of
Pusan, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Auris Medical, Inc.
More Information
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Additional Information:

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Responsible Party: Auris Medical, Inc.
ClinicalTrials.gov Identifier: NCT02809118    
Other Study ID Numbers: AM-111-CL-15-01
First Posted: June 22, 2016    Key Record Dates
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:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Disorders
Ear Diseases
 Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms