Trial · NCT01267994
A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
NCT01267994, Phase 1, Phase 2, Completed, Andrea Vambutas; results first posted 2015-04-06
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease. Trials, record NCT01267994. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01267994
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease
- NCT number
- NCT01267994
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 13 participants, actual
- Lead sponsor
- Andrea Vambutas
- Conditions
- Sensorineural Hearing Loss, Autoimmune Inner Ear Disease
- Interventions
- Anakinra
- First posted
- 2010-12-29
- Last updated
- 2018-01-10
- Results first posted
- 2015-04-06
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease | 180 days | The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days. |
| Secondary | Number of Serious Adverse Events Reported | 84 days | To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra |
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 | To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease | 180 days | responders | NUMBER | |
| SECONDARY | Number of Serious Adverse Events Reported | 84 days | Any subject enrolled in this study who received at least 1 injection dose of anakinra | reported SAEs | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease | Single Arm | 7 | responders | ||
| Number of Serious Adverse Events Reported | Single Arm | 0 | reported SAEs |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Open Label Trial | 12 | |
| Overall Study | COMPLETED | Open Label Trial | 10 | |
| Overall Study | NOT COMPLETED | Open Label Trial | 2 |
Source ClinicalTrials.gov
Adverse events11
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 reactions | Skin and subcutaneous tissue disorders | Single Arm | 10 | 12 | |
| other | Headache | Nervous system disorders | Single Arm | 4 | 12 | |
| other | Vertigo | Nervous system disorders | Single Arm | 3 | 12 | |
| other | Tinnitus | Ear and labyrinth disorders | Single Arm | 2 | 12 | |
| other | Influenza like illness | Respiratory, thoracic and mediastinal disorders | Single Arm | 1 | 12 | |
| other | Nausea | Gastrointestinal disorders | Single Arm | 2 | 12 | |
| other | Cellulitis | Skin and subcutaneous tissue disorders | Single Arm | 1 | 12 | |
| other | Sinusitis | Respiratory, thoracic and mediastinal disorders | Single Arm | 1 | 12 | |
| other | Wheezing | Respiratory, thoracic and mediastinal disorders | Single Arm | 1 | 12 | |
| other | Psoriasis Flare | Skin and subcutaneous tissue disorders | Single Arm | 1 | 12 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Single Arm | ||
| Total, other adverse events | Single Arm | 10 | 12 |
| Total, serious adverse events | Single Arm | 0 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25133431 | RESULT |
Source PubMed
Grants2
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R33DC011827 | A phase I clinical trial of Anakinra for Steroid-Resistant AIED | VAMBUTAS, ANDREA | FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2012 to 2015 | NIH RePORTER |
| R21DC011827 | A phase I clinical trial of Anakinra for Steroid-Resistant AIED | VAMBUTAS, ANDREA | FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH | NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS | 2011 | NIH RePORTER |
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/NCT01267994
GET https://conductscience.org/api/trials/v1/NCT01267994/registered