Trial · NCT02809118
Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
NCT02809118, Phase 3, Terminated, Auris Medical, Inc.; results first posted 2020-08-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment. Trials, record NCT02809118. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02809118
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of AM-111 as Acute Sudden Sensorineural Hearing Loss Treatment
- NCT number
- NCT02809118
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 56 participants, actual
- Lead sponsor
- Auris Medical, Inc.
- Conditions
- Hearing Loss, Idiopathic Sudden Sensorineural
- Interventions
- AM-111 0.4 mg/ml, AM-111 0.8 mg/ml, Placebo
- First posted
- 2016-06-22
- Last updated
- 2020-08-07
- Results first posted
- 2020-08-07
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Pure Tone Average (PTA) | Day 0 and Day 91: The study was prematurely terminated. | 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. |
| Secondary | Word Recognition Score (WRS) - Main Secondary | Day 0 and Day 91: The study was prematurely terminated. | Change in WRS from Day 0 to Day 91. The WRS was determined with country-/language-specific word lists. At least 20 mono- or disyllabic words were presented in random order. After each word was presented to the subject, the subject was asked to repeat it, and to guess it, if he/she was not sure of the word. 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Pure Tone Average (PTA) | Day 0 and Day 91: The study was prematurely terminated. | The study was prematurely terminated. No meaningful efficacy analysis could be performed on the data. | ||
| SECONDARY | Word Recognition Score (WRS) - Main Secondary | Day 0 and Day 91: The study was prematurely terminated. | The study was prematurely terminated. No meaningful efficacy analysis could be performed on the data. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 18 | |
| Overall Study | STARTED | AM-111 0.4 mg/ml | 19 | |
| Overall Study | STARTED | AM-111 0.8 mg/ml | 19 | |
| Overall Study | COMPLETED | Placebo | 18 | |
| Overall Study | COMPLETED | AM-111 0.4 mg/ml | 18 | |
| Overall Study | COMPLETED | AM-111 0.8 mg/ml | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | AM-111 0.4 mg/ml | 1 | |
| Overall Study | NOT COMPLETED | AM-111 0.8 mg/ml | 1 |
Source ClinicalTrials.gov
Adverse events225
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tinnitus | Ear and labyrinth disorders | Placebo | 1 | 18 | 1 |
| other | Tinnitus | Ear and labyrinth disorders | AM-111 0.4 mg/ml | 2 | 19 | 2 |
| other | Tinnitus | Ear and labyrinth disorders | AM-111 0.8 mg/ml | 1 | 19 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 1 | 18 | 1 |
| other | Vertigo | Ear and labyrinth disorders | AM-111 0.4 mg/ml | 0 | 19 | 0 |
| other | Vertigo | Ear and labyrinth disorders | AM-111 0.8 mg/ml | 0 | 19 | 0 |
| other | Vertigo positional | Ear and labyrinth disorders | Placebo | 1 | 18 | 1 |
| other | Vertigo positional | Ear and labyrinth disorders | AM-111 0.4 mg/ml | 0 | 19 | 0 |
| other | Vertigo positional | Ear and labyrinth disorders | AM-111 0.8 mg/ml | 1 | 19 | 1 |
| other | Ear discomfort | Ear and labyrinth disorders | Placebo | 0 | 18 | 0 |
1 to 10 of 225Source ClinicalTrials.gov
See all 225 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 18 |
| Total, all-cause mortality | AM-111 0.4 mg/ml | 0 | 19 |
| Total, all-cause mortality | AM-111 0.8 mg/ml | 0 | 19 |
| Total, other adverse events | Placebo | 8 | 18 |
| Total, other adverse events | AM-111 0.4 mg/ml | 11 | 19 |
| Total, other adverse events | AM-111 0.8 mg/ml | 10 | 19 |
| Total, serious adverse events | Placebo | 1 | 18 |
| Total, serious adverse events | AM-111 0.4 mg/ml | 1 | 19 |
| Total, serious adverse events | AM-111 0.8 mg/ml | 0 | 19 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02809118
GET https://conductscience.org/api/trials/v1/NCT02809118/events?page=2