Intratympanic Injection for Autoimmune Inner Ear Disease

Sponsor
House Research Institute
Study ID
NCT01526174
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Autoimmune Inner Ear Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — DRUG
    Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections

Study Details

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.

Key Dates

Start date
Mar 31, 2012
Status verified
Oct 2013
Primary completion
Dec 31, 2013
Completion
Apr 30, 2014

Study Design

Enrollment
16 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: First Arm
    Determine safety of intratympanic injection
  • Experimental: Second Arm
    Efficacy evaluation of 4 intratympanic injections

Primary Outcome Measure

Serious Adverse Events [ Time Frame: 30 days ]

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