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Cytokine Inhibitor

Anakinra for Meniere's Disease

Phase 2
Recruiting
Led By Andrea Vambutas, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet diagnostic criteria for Autoimmune Inner Ear Disease (AIED) with active deterioration in one ear as defined
Patients must be capable of understanding and giving informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at day 42
Awards & highlights

Study Summary

This trialwill test a drug, anakinra, in people with Meniere's and autoimmune inner ear diseases who don't respond to steroids. Patients will receive the drug or placebo for 42 days, then a second 42-day placebo period before 264 days of observation.

Who is the study for?
This trial is for adults with severe hearing loss due to Meniere's Disease or Autoimmune Inner Ear Disease who haven't improved with steroids. Participants must have stable or worsening hearing, not be on certain immunosuppressives, and can't start new diuretics before the trial. They should understand English, use effective birth control, and not have specific ear conditions or infections.Check my eligibility
What is being tested?
The study tests Anakinra (a drug) against a placebo in patients resistant to corticosteroids over two periods of 42 days each. Patients are randomly chosen to receive either Anakinra or placebo in a 2:1 ratio. After these periods, there's an observation phase where declines in hearing may be treated again with Anakinra.See study design
What are the potential side effects?
Anakinra might cause reactions at the injection site, increased risk of infections due to immune system suppression, allergic reactions if sensitive to E.coli-derived products, potential blood disorders like neutropenia (low white blood cell count), and possibly affect kidney function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with AIED and my hearing is getting worse in one ear.
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I understand the study and can agree to participate.
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I've tried or can't tolerate prednisone without getting better.
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I have finished all my steroid treatments.
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I am using a method of birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at day 42
This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sustained improvement in hearing thresholds
Secondary outcome measures
Improved Word Recognition

Side effects data

From 2018 Phase 2 & 3 trial • 104 Patients • NCT01809132
19%
Acute Kidney Injury
11%
Ascites
9%
Nausea
9%
Urinary tract infection
8%
Hematemesis
8%
Upper GI hemorrhage
8%
Clostridium difficile infection
6%
Hepatic failure
6%
Encephalopathy
6%
C. difficile infection
4%
Respiratory Failure
4%
Peritonitis
4%
Esophageal varices hemorrhage
4%
Tachycardia
4%
Multiple Organ Dysfunction Syndrome (MODS)
2%
Viremia
2%
Baceteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Anakinra & Pentoxifylline & Zinc Sulfate
Methylprednisolone
Observational

Trial Design

3Treatment groups
Experimental Treatment
Group I: Group CExperimental Treatment2 Interventions
This group will be randomized to receive intervention of placebo for 42 consecutive days in period 1 followed by 42 consecutive days of anakinra (100mg/0.67ml) in period 2
Group II: Group BExperimental Treatment2 Interventions
This group will be randomized to receive intervention of 42 consecutive days of anakinra (100 mg/0.67ml) in period 1 followed by 42 consecutive days of placebo in period 2
Group III: Group AExperimental Treatment2 Interventions
This group will be randomized to receive intervention of 42 consecutive days of anakinra (100mg/0.67ml) in period 1 followed by an additional 42 consecutive days of anakinra (100mg/0.67ml) in period 2

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,876 Total Patients Enrolled
Swedish Orphan BiovitrumIndustry Sponsor
92 Previous Clinical Trials
12,457 Total Patients Enrolled
Andrea Vambutas, MD3.911 ReviewsPrincipal Investigator - Northwell Health
Northwell Health
2 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Autoimmune Inner Ear Disease
13 Patients Enrolled for Autoimmune Inner Ear Disease
5Patient Review
I had an excellent experience with this physician. They were the only one who correctly diagnosed my issue after seeing three other doctors. They were very patient, kind, and caring. It can be tough to get an appointment, but it's worth the wait.

Media Library

Anakinra (Cytokine Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03587701 — Phase 2
Autoimmune Inner Ear Disease Research Study Groups: Group A, Group B, Group C
Autoimmune Inner Ear Disease Clinical Trial 2023: Anakinra Highlights & Side Effects. Trial Name: NCT03587701 — Phase 2
Anakinra (Cytokine Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03587701 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many enrollees does this research project have?

"From reviewing the information on clinicaltrials.gov, it appears that this study is still recruiting patients. The trial was first posted on 1/3/2019 and updated most recently on 10/18/2022. Currently, they are looking for 57 more participants at 1 site."

Answered by AI

Can elderly individuals participate in this experiment?

"Patients aged 18 to 75 are eligible for this clinical trial. If you are outside of that age range, there may be other trials more suited for you; 10 cater to those under 18 while 38 focus on patients over 65."

Answered by AI

Are patients being actively sought for this experiment?

"The trial is actively recruiting participants, as indicated by the clinicaltrials.gov website. The trial was posted on 1/3/2019 and updated on 10/18/2022. 57 participants are needed at 1 location."

Answered by AI

How is Anakinra 100Mg/0.67Ml Inj Syringe (Period 2) most often used?

"Anakinra 100Mg/0.67Ml Inj Syringe (Period 2) is most often used to treat sjia, however it can also be prescribed for neonatal-onset multisystem inflammatory disease (nomid), receptors, interleukin-1, and steroids."

Answered by AI

Are there any other drugs being tested in conjunction with Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)?

"34 separate medical trials are underway to study the effects of Anakinra 100Mg/0.67Ml Inj Syringe (Period 2). Out of those, 6 are in Phase 3. Most research is being conducted in Paris, Ile-De-France; however, there are 440 other locations also running similar studies."

Answered by AI

What are the potential risks associated with taking Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)?

"This medication, which is currently in Phase 2 trials, has some evidence backing its safety but not yet its efficacy. Therefore, it received a score of 2."

Answered by AI

Are there any restrictions for people who want to join this research project?

"This clinical trial is recruiting 57 people with labyrinthitis between the ages of 18 and 75. Most notable, applicants are required to meet the following criteria: they must have active deterioration in one ear as defined below, suffer from SNHL of greater than 30dB at one or more frequencies in the active ear. The contralateral ear may have any hearing threshold that is either stable or worsening, but may not exhibit improvement in response to corticosteroids even if the more active ear declines. Active deterioration is defined as a 15dB decline at one frequency (excluding 250 or 8kHz as a sole indicator) on their audiogram, or 10"

Answered by AI

Who else is applying?

What site did they apply to?
Northwell Health, Hearing& Speech Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Steroid injections do nothing for me. I am looking for some relief. I am open to trying options...
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease
Andrea Vambutas 2019. "Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03587701.
All > Autoimmune Hemolytic Anemia
~14 spots leftby Dec 2025
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