Is NCT03587701 recruiting in New Hyde Park, NY?

Yes, NCT03587701 is currently enrolling participants at its New Hyde Park, NY location. This autoimmune inner ear disease clinical trial is accepting qualified participants.

How do I join the autoimmune inner ear disease clinical trial in New Hyde Park?

To join this clinical trial in New Hyde Park, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this New Hyde Park clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Autoimmune Inner Ear Disease Clinical Trial in New Hyde Park, NY (Phase 2)

About This Autoimmune Inner Ear Disease Study in New Hyde Park

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.

Sponsor: Northwell Health

Who Can Participate

Inclusion Criteria

meet diagnostic criteria for Autoimmune Inner Ear Disease (AIED) with active deterioration in one ear as defined below

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 10dB at 2+ frequencies developing in \> or equal 3 days but \< or equal 90 days, or if the hearing loss evolved in less than 3 days, the patient displayed features suggestive of an autoimmune disorder

Capable of understanding and giving informed consent

Have 2 sequential audiograms following the decline in hearing \>or equal 28 days apart with no demonstrable improvement in hearing following corticosteroid therapy (\<or equal 5dB of improvement at any individual frequency (250, 500, 1000, 2000 and 4000Hz) and \<12% improvement in WRS)

Patients must have been treated with oral or IT prednisone with no demonstrable improvement or attempted to be treated and deemed intolerant. Steroid intolerance is defined as unable or unwilling to take corticosteroids because of a prior untoward effect or a current medical condition that would negatively be impacted by steroid use

Must have completed steroid therapy, including any intratympanic steroid therapy

Meniere's disease defined according to the AAO criteria, with the additional requirement of corticosteroid resistance AND no new diuretics may be instituted or dose increased from 28 days prior to trial enrollment

Patients must be fluent in English as all word recognition scores are based on testing in English

Patients may have other autoimmune disease(s) Females of childbearing potential, must be practicing a method of birth control considered effective and medically acceptable by the investigator for a minimum of 2 months prior to the study and at least 2 months after last administration of study drug

Males similarly must be practicing a method of birth control considered effective and medically acceptable by the investigator for a minimum of 2 months prior to the study and at least 2 months after last administration of study drug

Exclusion Criteria

Evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct) based on imaging

Prior treatment with gentamicin for Meniere's Disease

Most recent decline in hearing occurring \>90 days prior to trial enrollment

Positive test for Muckle-Wells mutation

Concurrently receiving methotrexate, TNF-antagonist therapy or any other immunosuppressive therapy

Steroid-dependent hearing loss

Any immunodeficiency syndrome

Active or chronic infections

Currently receiving, or having received treatment for a malignancy in the past 3 years

Chronic renal insufficiency (a creatinine clearance of \<49mL/min) or chronic renal failure

Neutropenia prior to treatment with anakinra

Receipt of live vaccine \<3 months prior to enrollment

Previous treatment with an IL-1 antagonist for any clinical indication

First-degree relative with a diagnosis of a CAPS disease

History of active narcotic abuts, including prescription narcotics

Pregnant or lactating females

Non-English speaking patients

Seropositive for Hepatitis B, C, HIV or tuberculosis on screening, with the exception of presence of antibodies to Hepatitis B in subjects reporting prior vaccination, and presence of positive skin testing for TB in subjects who received BCG in the past

History of suicidal ideation, significant depression that resulted in hospitalization, or answers "yes" during C-SSR screening

Prior participation in any type of clinical trial using a medication that inhibits interleukin-1 activity

Known hypersensitivity to E.coli derived products

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in New Hyde Park?

Yes, this clinical trial (NCT03587701) has an active research site in New Hyde Park, NY that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Autoimmune Inner Ear Disease Treatment Options in New Hyde Park, NY

If you're searching for autoimmune inner ear disease treatment options in New Hyde Park, NY, this clinical trial (NCT03587701) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our New Hyde Park research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced autoimmune inner ear disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all autoimmune inner ear disease clinical trials near you to find additional studies recruiting in your area.

Autoimmune Inner Ear Disease Clinical Trial in New Hyde Park, NY

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