Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss

NCT02414152 | Terminated Phase 1 Results DMC

• 1 other identifier: 13-333B
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if anakinra (an interleukin-1 receptor antagonist) can improve hearing thresholds in patients with sudden sensorineural hearing loss that did not respond to oral steroid therapy. 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. The investigators will be measuring hearing thresholds (Pure tone average and word recognition scores) before and after anakinra and correlating these findings with circulating IL-1 levels in the patient's blood.

Conditions

Hearing Loss, Sudden

Outcome Measures

Primary Outcomes (1)

• Response to Anakinra in Corticosteroid Resistant Patients With SSNHL

  Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.

  120 days

Study Arms (1)

anakinra

EXPERIMENTAL

100mg of Anakinra administered as a daily subcutaneous injection

Drug: anakinra

Interventions

anakinra DRUG

100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response

Also known as: Kineret

anakinra

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have Sudden Sensorineural Hearing Loss in one ear, with a no greater than 25 dB PTA in the contralateral ear.
• Age and Gender: male and female subjects, age ≥ 18 but ≤ 75, will be recruited.
• Patients must be capable of understanding and giving informed consent.
• Patients must have SNHL of greater than or equal to 30dB at three contiguous frequencies in one ear which evolved in three days or less, with a PTA of 25dB or less in the contralateral ear.
• Patients must have previously undergone a trial of high-dose corticosteroid therapy, at 60 mg daily for a minimum of seven days, with a variable taper thereafter that consists of a total of 14 consecutive days of corticosteroid use. Patients must have demonstrated less than a 5 decibel average improvement in their PTA in response to corticosteroids as measured by their audiogram.
• NO greater than 30 days may elapse from the discontinuation from the initial course of steroid treatment to the time of enrollment.

You may not qualify if:

• Patients over 75 years of age, because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
• Patients with evidence of retrocochlear pathology (vestibular schwannoma) or inner ear malformation (Mondini Malformation or Enlarged Vestibular Aqueduct) based on imaging.
• Patients concurrently receiving methotrexate or TNF-antagonist therapy.
• Patients with a diagnosis of any immunodeficiency syndrome.
• Patients with active or chronic infections.
• Patients currently receiving, or having received treatment for a malignancy in the past three years.
• Patients with a diagnosis of chronic renal insufficiency (a creatinine clearance of \<49mL/min) or chronic renal failure.
• Patients with evidence of neutropenia (an ANC of \<1000) prior to treatment with anakinra.
• Known hypersensitivity to E. coli derived products.
• Latex sensitivity.
• Any patient that received a live vaccine \< 3 months prior to enrollment.
• Any patient with a history of active narcotic abuse, including prescription narcotics.
• Pregnant or lactating females.
• Children, \< age 18
• Non-English speaking patients, as the word recognition scoring is in English and is a vital component to the efficacy analysis.

Sponsors & Collaborators

• Andrea Vambutas: lead

Study Sites (1)

North Shore-LIJ Hearing and Speech Center

New Hyde Park, New York, 11040, United States

Location

Related Publications (1)

• 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.

  PMID: 25133431 RESULT

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Limitations and Caveats

Early termination of the study secondary to inability to secure funding.

Results Point of Contact

• Title: Dr. Andrea Vambutas
• Organization: Northwell Health

avambuta@northwell.edu

718-470-7550

Study Officials

• Andrea Vambutas, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair, Department of Otolaryngology and Communicative Disorders

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: April 10, 2015
• Study Start: October 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: March 13, 2017
• Results First Posted: December 5, 2016

Record last verified: 2017-01

Locations

US (1)