TerminatedPhase 1/2

Intratympanic Injection for Autoimmune Inner Ear Disease

Stopped: House Research no longer conducting research.

16 participantsStarted 2012-03

Plain-language summary

The investigators plan to conduct an open-label intratympanic injection proof-of-concept trial of golimumab, a TNF-alpha inhibitor, assessing for hearing loss progression in patients with autoimmune inner ear disease (AIED). This specific aim will be achieved using a two-arm approach. First, the investigators propose to dose 3 individual subjects with a single intratympanic injection of golimumab and follow each for 30 days, closely examining them for adverse events. If there are no serious adverse events, with FDA approval, the investigators propose to dose 14 subjects, each with 4 intratympanic injections of golimumab.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of autoimmune inner ear disease (AIED) by the principal investigator * Idiopathic, bilateral sensorineural hearing loss * History of, or audiograms showing, rapid progression of hearing loss * Bilateral loss of at least 30 dB in one or more frequencies (0.25 - 6 kHz) * Hearing responsive on high-dose oral steroids and steroid-dependent, as determined by history and the principal investigator. The subject can be taking oral steroid, at the maintenance level, if enrolled in the First Arm and, if enrolled in the Second Arm, will begin taper after the first injection. * Provided written informed consent for participation in the clinical study Exclusion Criteria: * Positive MRI for vestibular schwannoma * Positive FTA (syphilis) * Significant middle ear disease (e.g., otitis media) * Positive blood test for Lyme disease * Positive tuberculosis test * Concurrent or past treatment or use of medications and/or substances known to cause ototoxicity(for example, aminoglycosides \[e.g., gentamicin\], cisplatin, loop diuretics, Yorgason et al., 2006) * Known adverse reaction to golimumab, adalimumab, etanercept, infliximab, rituximab, ustekinumab, or other biologic immunomodulators * Concurrent (within the past 3 months prior to enrollment) live viral intranasal vaccine (flu) * Positive test for HIV * Positive test for Hepatitis B and C * Presence of a demyelinating disease, such as multiple sclerosis * Women of childbearing potential only: Positive ser…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serious Adverse Events

Timeframe: 30 days

Pure-tone threshold change

Timeframe: 6 weeks

Trial details

NCT IDNCT01526174

SponsorHouse Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Autoimmune Inner Ear Disease trials