Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-05 @ 2:31 PM
Study NCT ID:
NCT02828033
Status:
UNKNOWN
Last Update Posted:
2017-09-13
First Post:
2016-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss
Sponsor:
Stanley Cohen
Organization:
Study Overview
Official Title:
A Pilot Trial of Rilonacept for Treatment of Autoimmune Neurosensory Hearing Loss
Status:
UNKNOWN
Status Verified Date:
2017-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is an open label proof of concept study of rilonacept for patients with ANSHL
Detailed Description:
Ten (10) patients in total will be enrolled in this study at Metroplex Clinical Research Center in Dallas, TX. Patients may be identified and referred by local area audiologist. The ANSHL study population will be defined by inclusion and exclusion criteria designed to limit enrollment to individuals with idiopathic, progressive, bilateral sensorineural hearing loss, to ensure appropriate candidates for treatment with study medications, and to identify those with a high likelihood of complying with the study protocol.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: