Trial · NCT02414152
Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss
NCT02414152, Phase 1, Phase 2, Terminated, Andrea Vambutas; results first posted 2016-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss. Trials, record NCT02414152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02414152
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss
- NCT number
- NCT02414152
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 2 participants, actual
- Lead sponsor
- Andrea Vambutas
- Conditions
- Hearing Loss, Sudden
- Interventions
- anakinra
- First posted
- 2015-04-10
- Last updated
- 2017-03-13
- Results first posted
- 2016-12-05
- Limitations and caveats
- Early termination of the study secondary to inability to secure funding.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Response to Anakinra in Corticosteroid Resistant Patients With SSNHL | 120 days | Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Response to Anakinra in Corticosteroid Resistant Patients With SSNHL | 120 days | Zero subjects were analyzed because both enrolled subjects were withdrawn after receiving 56 days of anakinra because no hearing improvement was noted. They did not complete the entire study. |
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 flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Anakinra | 2 | |
| Overall Study | COMPLETED | Anakinra | 0 | |
| Overall Study | NOT COMPLETED | Anakinra | 2 |
Source ClinicalTrials.gov
Adverse events6
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 | injection site reaction | Skin and subcutaneous tissue disorders | Anakinra | 2 | 2 | |
| other | headache | Nervous system disorders | Anakinra | 1 | 2 | |
| other | fatigue | General disorders | Anakinra | 1 | 2 | |
| other | leg edema | Vascular disorders | Anakinra | 1 | 2 | |
| other | dermatitis | Skin and subcutaneous tissue disorders | Anakinra | 1 | 2 | |
| other | increased tinnitus | Ear and labyrinth disorders | Anakinra | 1 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Anakinra | ||
| Total, other adverse events | Anakinra | 2 | 2 |
| Total, serious adverse events | Anakinra | 0 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25133431 | RESULT |
Source PubMed
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/NCT02414152
GET https://conductscience.org/api/trials/v1/NCT02414152/registered