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A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

Primary Purpose

Sensorineural Hearing Loss, Autoimmune Inner Ear Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Anakinra

About this trial

This is an interventional treatment trial for Sensorineural Hearing Loss focused on measuring Steroid, Steroid-Resistant, Autoimmune Inner Ear Disease, Immune Mediated Hearing Loss, Sudden Sensorineural Hearing Loss, Meniere's Disease, Autoimmune, Hearing

Eligibility Criteria

13 Years - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Bilateral sensorineural hearing loss with an active decline in hearing in one ear
No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days
Enrollment within 14 days of completion of corticosteroid therapy
Age 13 years and older
No evidence of neutropenia (low white blood cell count)
No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma)
May have concurrent, systemic autoimmune disease

Exclusion Criteria:

Age over 75, or less than 13
Neutropenia
Renal insufficiency
Pregnant females
Unilateral hearing loss
Patients with any immunodeficiency syndrome
Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy
Patients with chronic infections
Patients treated for a malignancy within the past 3 years
Patients with a latex allergy
Patients with an inner ear anomaly
Patients with retrocochlear pathology

Sites / Locations

North Shore-LIJ Hearing and Speech Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm-Open Label

Arm Description

Single Arm-Open Label use of Anakinra

Outcomes

Primary Outcome Measures

To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease

The primary endpoint is to determine whether those treated with anakinra for 84 days demonstrate an improved hearing threshold compared with their pre-anakinra-treatment threshold. Audiometric thresholds will be compared to those treated with a prolonged corticosteroid taper and those that elect for no further treatment. The durability of the response will be measured over a total of 180 days.

Secondary Outcome Measures

Number of Serious Adverse Events Reported

To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra

Full Information

NCT ID

NCT01267994

First Posted

December 28, 2010

Last Updated

December 12, 2017

Sponsor

Andrea Vambutas

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

1. Study Identification

Unique Protocol Identification Number

NCT01267994

Brief Title

A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

Official Title

A Phase I/II Open-label Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

June 2011 (undefined)

Primary Completion Date

September 2014 (Actual)

Study Completion Date

September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Andrea Vambutas

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine if Anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in those patients with Autoimmune Inner Ear Disease (AIED) that did not respond to oral steroid therapy for a sudden decline in hearing. The patients to be enrolled will have recently completed a course of oral steroids and demonstrated no change in their audiometric thresholds following corticosteroid therapy.

Detailed Description

Patients with immune mediated hearing loss (also known as autoimmune hearing loss) are typically treated with corticosteroids. Of those treated, approximately 60% respond, however, that response may be lost over time. Other therapies use to date have proven largely ineffectual in improving hearing. This study proposes a phase I open label clinical trial of Anakinra for corticosteroid-resistant patients to determine if this therapy is efficacious in hearing restoration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sensorineural Hearing Loss, Autoimmune Inner Ear Disease

Keywords

Steroid, Steroid-Resistant, Autoimmune Inner Ear Disease, Immune Mediated Hearing Loss, Sudden Sensorineural Hearing Loss, Meniere's Disease, Autoimmune, Hearing

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm-Open Label

Arm Type

Experimental

Arm Description

Single Arm-Open Label use of Anakinra

Intervention Type

Drug

Intervention Name(s)

Anakinra

Other Intervention Name(s)

Kineret

Intervention Description

100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.

Primary Outcome Measure Information:

Title

To Assess the Potential Efficacy of Anakinra in Improving Hearing Thresholds in Corticosteroid-resistant Patients With Autoimmune Inner Ear Disease

Description

Time Frame

180 days

Secondary Outcome Measure Information:

Title

Number of Serious Adverse Events Reported

Description

To assess the number of Serious Adverse Events reported in any subject that received at least one injection dose of anakinra

Time Frame

84 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Bilateral sensorineural hearing loss with an active decline in hearing in one ear No audiometric improvement with 28-30 days of oral prednisone or other corticosteroid, including an initial dose of 60mg per day for 14 days Enrollment within 14 days of completion of corticosteroid therapy Age 13 years and older No evidence of neutropenia (low white blood cell count) No evidence of retrocochlear pathology (ie. acoustic neuroma/vestibular schwannoma) May have concurrent, systemic autoimmune disease Exclusion Criteria: Age over 75, or less than 13 Neutropenia Renal insufficiency Pregnant females Unilateral hearing loss Patients with any immunodeficiency syndrome Patients receiving methotrexate or any TNF (tumor necrosis factor) antagonist therapy Patients with chronic infections Patients treated for a malignancy within the past 3 years Patients with a latex allergy Patients with an inner ear anomaly Patients with retrocochlear pathology

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrea Vambutas, MD

Organizational Affiliation

Northwell Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

North Shore-LIJ Hearing and Speech Center

City

New Hyde Park

State/Province

New York

ZIP/Postal Code

11040

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

25133431

Citation

Vambutas A, Lesser M, Mullooly V, Pathak S, Zahtz G, Rosen L, Goldofsky E. Early efficacy trial of anakinra in corticosteroid-resistant autoimmune inner ear disease. J Clin Invest. 2014 Sep;124(9):4115-22. doi: 10.1172/JCI76503. Epub 2014 Aug 18.

Results Reference

result

Links:

URL

http://www.feinsteininstitute.org/Feinstein/Clinical+Trials

Description

Clinical trials at the Feinstein Institute for Medical Research

Learn more about this trial

A Clinical Trial of Anakinra for Steroid-Resistant Autoimmune Inner Ear Disease

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