Trial · NCT02040194
AM-101 in the Treatment of Acute Tinnitus 3
NCT02040194, Phase 3, Completed, Auris Medical AG
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. AM-101 in the Treatment of Acute Tinnitus 3. Trials, record NCT02040194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02040194
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- AM-101 in the Treatment of Acute Tinnitus 3
- NCT number
- NCT02040194
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 893 participants, actual
- Lead sponsor
- Auris Medical AG
- Conditions
- Tinnitus
- Interventions
- AM-101, Placebo
- First posted
- 2014-01-20
- Last updated
- 2023-09-14
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Efficacy endpoint - alternate primary efficacy endpoints: Tinnitus Functional Index (TFI) | Baseline to Day 84 | Improvement in TFI total score |
| Primary | Efficacy endpoint - alternate primary efficacy endpoints: Patient-reported Tinnitus loudness on a Numerical Rating Scale (TLQ NRS loudest) | Baseline to Day 84 | Improvement in TLQ NRS loudest |
| Primary | Safety endpoint: Hearing threshold | Baseline to Day 35 | Occurrence of deterioration in hearing threshold \>= 15 decibel (dB) at the average of two contiguous test frequencies (air conduction) in the treated ear(s) |
| Secondary | Efficacy endpoint - TFI | Baseline to Day 10 and Day 35 | Improvement in TFI total score |
| Secondary | Efficacy endpoint - TLQ NRS loudest | Baseline to Day 10 and Day 35 | Improvement in patient-reported tinnitus loudness |
| Secondary | Efficacy endpoint - patient-reported tinnitus annoyance (TAQ NRS worst) | Baseline to Day10, Day 35 and Day 84 | Improvement in TAQ NRS worst |
| Secondary | Efficacy endpoint - TFI sleep score | Baseline to Day10, Day 35 and Day 84 | Improvement in TFI sleep score. The subscale "sleep" will be evaluated only for subjects with a TFI Sleep score greater than 0 at baseline. |
| Secondary | Efficacy endpoint - Patient global impression of change in tinnitus severity (PGIC Tinnitus) | at Day10, Day 35 and Day 84 | Patient global impression of change in tinnitus severity |
| Secondary | Safety endpoint - Hearing threshold | Baseline to Day 1, Day 2, Day 10 and Day 84 | Occurrence of deterioration in hearing threshold \>= 15 dB at the average of two contiguous test frequencies in the treated ear(s) |
| Secondary | Safety endpoint - Hearing threshold | Baseline to Day 1, Day 2, Day 10 and Day 84 | Difference in occurrence of deterioration in hearing threshold \>= 15 dB at the average of two contiguous test frequencies between the treated and untreated contralateral ear (subjects with unilaterally treated tinnitus only) |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT02040194
GET https://conductscience.org/api/trials/v1/NCT02040194/registered