Clinical Trial: Intratympanic Injection for Autoimmune Inner Ear Disease

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Safety and Efficacy of Intratympanically Delivered Golimumab for Stabilization of Hearing in Patients With Autoimmune Inner Ear Disease: An Open-label Proof-of-concept Cli

Brief 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.

Detailed Summary:
Sponsor: House Research Institute

Current Primary Outcome:

• Serious Adverse Events [ Time Frame: 30 days ]
  Serious Adverse Events
• Pure-tone threshold change [ Time Frame: 6 weeks ]
  Change in pure-tone threshold from baseline to 6 week after initiation of treatment

Original Primary Outcome:

• Serious Adverse Events [ Time Frame: 30 days ]
  Serious Adverse Events
• Pure-tone threshold change [ Time Frame: 6 weeks ]
  Change in pure-tone threshold

Current Secondary Outcome:

Original Secondary Outcome:

Information By: House Research Institute

Dates:
Date Received: February 1, 2012
Date Started: March 2012
Date Completion: April 2014
Last Updated: October 10, 2013
Last Verified: October 2013