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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

Must not have

Prior treatment with gentamicin for Meniere's Disease

Previous treatment with an IL-1 antagonist

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at day 28

Awards & highlights

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been treated with gentamicin for Meniere's Disease.

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I have been treated with an IL-1 blocker before.

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A close family member has been diagnosed with a CAPS disease.

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I have been in a clinical trial for specific medications before.

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I have an ongoing infection.

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My hearing loss improves with steroid treatment.

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I have a history of significant depression or thoughts of suicide.

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I have been treated for cancer within the last 3 years.

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I had low white blood cell counts before starting anakinra.

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I have tested positive for the Muckle-Wells mutation.

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I have long-term kidney problems.

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I am currently on specific treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and at day 28 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

Nausea

Urinary tract infection

Hematemesis

Upper GI hemorrhage

Clostridium difficile infection

Hepatic failure

Encephalopathy

C. difficile infection

Respiratory Failure

Peritonitis

Esophageal varices hemorrhage

Tachycardia

Multiple Organ Dysfunction Syndrome (MODS)

Viremia

Baceteremia

100%

80%

60%

40%

20%

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

0 / 17Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

473 Previous Clinical Trials

472,215 Total Patients Enrolled

Swedish Orphan BiovitrumIndustry Sponsor

96 Previous Clinical Trials

12,607 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.