Trial · NCT03587701
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
NCT03587701, Phase 2, Recruiting, Andrea Vambutas
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease. Trials, record NCT03587701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03587701
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
- NCT number
- NCT03587701
- Status
- Recruiting
- Phases
- Phase 2
- Enrollment
- 57 participants, estimated
- Lead sponsor
- Andrea Vambutas
- Conditions
- Autoimmune Inner Ear Disease, Meniere's Disease
- Interventions
- Anakinra 100Mg/0.67Ml Inj Syringe (Period 1), Placebo injection (Period 1), Anakinra 100Mg/0.67Ml Inj Syringe (Period 2), Placebo injection (Period 2)
- First posted
- 2018-07-16
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained improvement in hearing thresholds | Hearing improvement from pre-treatment thresholds at day 28 | Determine whether those treated with anakinra demonstrate a sustained improvement in hearing thresholds compared with their pre-anakinra treatment threshold. Improvement will be defined by an improvement of 15dB at 1 frequency or 10dB at 2 contiguous frequencies with no greater than a 5dB worsening all remaining frequencies |
| Primary | Sustained improvement in hearing thresholds | Hearing improvement from pre-treatment thresholds at day 42 | threshold. Improvement will be defined by an improvement of 15dB at 1 frequency or 10dB at 2 contiguous frequencies with no greater than a 5dB worsening all remaining frequencies |
| Secondary | Improved Word Recognition | at day 28 | Determine whether those treated with anakinra demonstrate a sustained improvement in word recognition score compared with their pre-anakinra treatment threshold. Improvement will be defined by an improvement of greater than 12% change in value |
| Secondary | Improved Word Recognition | at day 42 | Determine whether those treated with anakinra demonstrate a sustained improvement in word recognition score compared with their pre-anakinra treatment threshold. Improvement will be defined by an improvement of greater than 12% change in value |
Source ClinicalTrials.gov
Outcomes0
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.
Papers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT03587701
GET https://conductscience.org/api/trials/v1/NCT03587701/registered