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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: Recruiting Phase 2 study of Autoimmune Inner Ear Disease and Meniere's Disease, sponsored by Northwell Health.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What NCT03587701 shows while recruiting
NCT03587701 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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.
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Where NCT03587701's enrollment target sits among peer trials
57 1141st of 2000 higher than 856 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
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