Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03587701 · ClinicalTrials.gov registry record · Phase 2
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
A Phase 2 study of Autoimmune Inner Ear Disease and Meniere's Disease, sponsored by Northwell Health.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 57
- Enrollment target
- 1
- Study location
NCT03587701 is a Phase 2 study of Autoimmune Inner Ear Disease and Meniere's Disease that is actively recruiting participants, run by Northwell Health. The registered enrollment target is 57 participants. The trial reports 1 study location across 1 state.
The verdict
NCT03587701, a Phase 2 study of Autoimmune Inner Ear Disease and Meniere's Disease, is actively recruiting participants, sponsored by Northwell Health.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 57 participants
- Enrollment target
- 1
- Study location
Study Summary
A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant or intolerant Meniere's disease (CR-MD)and corticosteroid-resistant or intolerant autoimmune inner ear disease (CR-AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or placebo for 42 continuous days. After day 42, a second placebo-controlled period will begin for an additional 42 days. This will be followed by a 264 day observation period, during which, hearing declines may be re-treated with anakinra after 30 days following the initial drug.
Conditions Studied
Interventions
- DRUG Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)
- DRUG Placebo injection (Period 1)
- DRUG Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)
- DRUG Placebo injection (Period 2)
Study Locations (1)
New York
- Northwell Health, Hearing& Speech Center - New Hyde Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2019-01-03 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03587701
The ClinicalTrials.gov registry entry for NCT03587701 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northwell Health, which has 370 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Autoimmune Inner Ear Disease appearing as the primary indexed condition, and to 4 interventions - of which Anakinra 100Mg/0.67Ml Inj Syringe (Period 1) is the first listed.
NCT03587701 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03587701 about?
NCT03587701 is a clinical study titled "Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease". A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant or intolerant Meniere's disease (CR-MD)and corticosteroid-resistant or intolerant autoimmune inner ear disease (CR-AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or p...
What is the current status of trial NCT03587701?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 57 participants. The study started on 2019-01-03. Estimated completion is 2025-12-31.
What conditions does trial NCT03587701 study?
This clinical trial studies the following conditions: Autoimmune Inner Ear Disease, Meniere's Disease.
What interventions are being tested in trial NCT03587701?
The interventions under investigation include: Anakinra 100Mg/0.67Ml Inj Syringe (Period 1) (DRUG), Placebo injection (Period 1) (DRUG), Anakinra 100Mg/0.67Ml Inj Syringe (Period 2) (DRUG), Placebo injection (Period 2) (DRUG).
Who is sponsoring clinical trial NCT03587701?
This trial is sponsored by Northwell Health, which has 370 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03587701 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autoimmune Inner Ear Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.