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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Jun 2016

Geographic Reach

3 countries

51 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.7 years study duration

Study Start

First participant enrolled

June 1, 2016

Completed

19 days until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

August 7, 2020

Completed

Last Updated

August 7, 2020

Status Verified

June 1, 2020

Enrollment Period

1.7 years

First QC Date

June 20, 2016

Results QC Date

April 24, 2020

Last Update Submit

July 24, 2020

Conditions

Hearing Loss, Idiopathic Sudden Sensorineural

Keywords

DeafnessHearing LossHearing Loss, SensorineuralEar DiseasesHearing DisordersNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsHearing and Speech ImpairmentHearing Loss, Unilateral

Outcome Measures

Primary Outcomes (1)

Pure Tone Average (PTA)
Measurement of the recovery of hearing between Day 0 (before treatment) and Day 91, i.e. change in pure tone audiometry between Day 0 and Day 91. The study was prematurely terminated. It was pre-specified not to complete analyses due to premature termination. Not all data planned were collected. No meaningful efficacy analysis could be performed on the data.
Day 0 and Day 91: The study was prematurely terminated.

Secondary Outcomes (1)

Word Recognition Score (WRS) - Main Secondary
Day 0 and Day 91: The study was prematurely terminated.

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo gel for intratympanic use

Other: Placebo

AM-111 0.4 mg/ml

EXPERIMENTAL

AM-111 gel for intratympanic use (0.4 mg/ml AM-111)

Drug: AM-111 0.4 mg/ml

AM-111 0.8 mg/ml

EXPERIMENTAL

AM-111 gel for intratympanic use (0.8 mg/ml AM-111)

Drug: AM-111 0.8 mg/ml

Interventions

AM-111 0.4 mg/mlDRUG

AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia

Also known as: Brimapitide

AM-111 0.4 mg/ml

AM-111 0.8 mg/mlDRUG

AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia

Also known as: Brimapitide

AM-111 0.8 mg/ml

PlaceboOTHER

Placebo gel is administered with a single dose into the affected ear after topical anesthesia

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Unilateral idiopathic sudden sensorineural hearing loss (ISSNHL) with onset within 72 hours prior to study treatment;
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);
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;
Age ≥ 18 years on the day of screening;

You may not qualify if:

Bilateral ISSNHL;
Acute hearing loss from noise trauma, barotrauma or head trauma;
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;
History of autoimmune hearing loss, radiation-induced hearing loss, endolymphatic hydrops or Menière's disease in either ear;
History of chronic inflammatory or suppurative ear disease or cholesteatoma in the affected ear;
Current evidence or history of acoustic neuroma or other retrocochlear damage in the affected ear;
History of otosclerosis in the affected ear;
Suspected perilymph fistula or membrane rupture in the affected ear;
Congenital hearing loss;
History of ISSNHL in the past 2 years;
Otitis media or otitis externa that is ongoing or ended within 7 days prior to study treatment;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Auris Medical, Inc.lead

Study Sites (51)

Unknown Facility

Birmingham, Alabama, 35294-0012, United States

Location

Unknown Facility

Escondido, California, 92025, United States

Location

Unknown Facility

Fresno, California, 93720, United States

Location

Unknown Facility

La Jolla, California, 92037-1214, United States

Location

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

New Haven, Connecticut, 06519, United States

Location

Unknown Facility

Boca Raton, Florida, 33487, United States

Location

Unknown Facility

Boynton Beach, Florida, 33426-6398, United States

Location

Unknown Facility

Celebration, Florida, 34747, United States

Location

Unknown Facility

Miami, Florida, 33133, United States

Location

Unknown Facility

Miami, Florida, 33176, United States

Location

Unknown Facility

Port Saint Lucie, Florida, 34952, United States

Location

Unknown Facility

Chicago, Illinois, 60657, United States

Location

Unknown Facility

Des Moines, Iowa, 50312, United States

Location

Unknown Facility

Kansas City, Kansas, 66160, United States

Location

Unknown Facility

Louisville, Kentucky, 40207, United States

Location

Unknown Facility

Novi, Michigan, 48374, United States

Location

Unknown Facility

Columbia, Missouri, 65212, United States

Location

Unknown Facility

Lebanon, New Hampshire, 03756, United States

Location

Unknown Facility

Charlotte, New York, 28210, United States

Location

Unknown Facility

New Hyde Park, New York, 11042-1121, United States

Location

Unknown Facility

New Windsor, New York, 12553, United States

Location

Unknown Facility

New York, New York, 10032, United States

Location

Unknown Facility

Rochester, New York, 14618, United States

Location

Unknown Facility

White Plains, New York, 10601-4413, United States

Location

Unknown Facility

Matthews, North Carolina, 28105, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103-1522, United States

Location

Unknown Facility

Havertown, Pennsylvania, 19083, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19107, United States

Location

Unknown Facility

Charleston, South Carolina, 29425, United States

Location

Unknown Facility

Lugoff, South Carolina, 29078, United States

Location

Unknown Facility

Orangeburg, South Carolina, 29118, United States

Location

Unknown Facility

Nashville, Tennessee, 37232-8605, United States

Location

Unknown Facility

Fort Sam Houston, Texas, 78234, United States

Location

Unknown Facility

Salt Lake City, Utah, 84102, United States

Location

Unknown Facility

St. George, Utah, 84790, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

Unknown Facility

Tacoma, Washington, 98431-1100, United States

Location

Unknown Facility

Kelowna, British Columbia, Canada

Location

Unknown Facility

Penticton, British Columbia, Canada

Location

Unknown Facility

Markham, Ontario, Canada

Location

Unknown Facility

Seongnam-si, Gyeonggi-do, South Korea

Location

Unknown Facility

Suwon, Gyeonggi-do, South Korea

Location

Unknown Facility

Incheon, Jung-Gu, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Pusan, South Korea

Location

Unknown Facility

Seoul, 3722, South Korea

Location

Unknown Facility

Seoul, 61469, South Korea

Location

Unknown Facility

Seoul, 6591, South Korea

Location

Unknown Facility

Seoul, 8308, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Hearing LossDeafnessHearing Loss, SensorineuralEar DiseasesHearing DisordersNervous System DiseasesNeurologic ManifestationsOtorhinolaryngologic DiseasesSensation DisordersSigns and SymptomsSpeech DisordersHearing Loss, Unilateral

Interventions

D-JNKI-1

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and SymptomsLanguage DisordersCommunication DisordersNeurobehavioral Manifestations

Results Point of Contact

Title: RAM
Organization: Auris Medical

Study Officials

Thomas Meier
Auris Medical, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 7, 2020

Results First Posted

August 7, 2020

Record last verified: 2020-06

Locations

KR(10)CA(3)US(38)

Study Stopped

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Placebo

AM-111 0.4 mg/ml

AM-111 0.8 mg/ml

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (51)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (3)

Placebo

AM-111 0.4 mg/ml

AM-111 0.8 mg/ml

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (51)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Study Design

Study Record Dates

Locations