Hearing Loss, SuddenPhase 1/2SSNHLNCT02414152
Study of the Effects of Anakinra in Corticosteroid-resistant Subjects With Sudden Sensorineural Hearing Loss
A Phase 1/2 study testing anakinra in people with Hearing Loss, Sudden, run by Andrea Vambutas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hearing Loss, Sudden
- What is being tested?
- anakinra
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jul 2015
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- Any patient that tests positive 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
North Shore-LIJ Hearing and Speech Center
New Hyde Park, New York, 11040
About this study
Official title: A Phase I & II Open-label Study of the Effects of Anakinra (Kineret) in Corticosteroid-resistant Subjects With Sudden Sensorineural Heaing Loss (SSNHL)
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.
Read the detailed description
For patients that experience an acute, sensorineural decline in hearing, timely corticosteroid administration may result in preservation of some or all of the hearing. For patients with sudden sensorineural hearing loss who have failed to respond to corticosteroid therapy, this study will be offered to determine if anakinra is a safe and effective alternative therapy for clinical hearing restoration. The investigators have previously demonstrated that IL-1beta inhibition (with anakinra) in a small cohort of patients with steroid resistant autoimmune inner ear disease was effective in demonstrating audiological improvements.
- Conditions
- Hearing Loss, Sudden
- Being tested
- anakinra
- Medical subject headings
- Hearing Loss, Sudden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anakinraDrug
Also called Kineret
100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response
| Study group | Role | What they receive |
|---|---|---|
| anakinra | Experimental | 100mg of Anakinra administered as a daily subcutaneous injection Receives: Drug: anakinra |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJul 2015
Why it stopped: Early study termination occurred due to inability to secure funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, SuddenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrea Vambutas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrea Vambutas, Northwell Health
- Investigators
- Andrea Vambutas, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414152
- Sponsor's protocol ID
- 13-333B
- Acronym
- SSNHL
- Status last verified
- Jan 2017
- First submitted
- 23 Feb 2015
- Last updated
- 13 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 25133431
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I & II Open-label Study of the Effects of Anakinra (Kineret) in Corticosteroid-resistant Subjects With Sudden Sensorineural Heaing Loss (SSNHL)
- ClinicalTrials.gov ID
- NCT02414152
- Acronym / sponsor ID
- SSNHL / 13-333B
- Conditions
- Hearing Loss, Sudden
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Early study termination occurred due to inability to secure funding
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Andrea VambutasUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Posted 5 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
For patients that experience an acute, sensorineural decline in hearing, timely corticosteroid administration may result in preservation of some or all of the hearing. For patients with sudden sensorineural hearing loss who have failed to respond to corticosteroid therapy, this study will be offered to determine if anakinra is a safe and effective alternative therapy for clinical hearing restoration. The investigators have previously demonstrated that IL-1beta inhibition (with anakinra) in a small cohort of patients with steroid resistant autoimmune inner ear disease was effective in demonstrating audiological improvements.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anakinra | Experimental | Drug: anakinra100mg of Anakinra administered as a daily subcutaneous injection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anakinraAlso: Kineret100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response | Drug | anakinra |
Primary outcome
Response to Anakinra in Corticosteroid Resistant Patients With SSNHL
Time frame: 120 days
Patients who had a response to anakinra based on hearing threshold improvement compared to their pre-treatment threshold.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 25133431Vambutas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Vambutas, MD principal investigator
Northwell Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing anakinra in people with Hearing Loss, Sudden, run by Andrea Vambutas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to Anakinra in Corticosteroid Resistant Patients With SSNHL (time frame: 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02414152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.