Intratympanic Injection for Autoimmune Inner Ear Disease — AIED  

Autoimmune Inner Ear Disease Clinical Trial

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 Clinical Trial

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autoimmune Inner Ear Disease
• Ear Diseases
• Labyrinth Diseases
• Labyrinthitis

• NCT number: NCT01526174
• Study type: Interventional
• Source: House Research Institute
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: March 2012
• Completion date: April 2014