Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-25 @ 7:21 PM
Study NCT ID:
NCT02779192
Status:
UNKNOWN
Last Update Posted:
2018-08-24
First Post:
2016-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase 2b Study of SPI-1005 to Prevent Acute Noise Induced Hearing Loss
Sponsor:
Sound Pharmaceuticals, Incorporated
Organization:
Study Overview
Official Title:
A Phase 2b, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of SPI-1005 to Prevent Acute Noise Induced Hearing Loss (PANIHL)
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANIHL
Brief Summary:
SPI-1005 is a novel oral drug that contains a glutathione peroxidase mimetic (ebselen) that will be tested in subjects with a history of NIHL at risk for additional NIHL. The goal of this multi-center Phase 2b study is to determine whether SPI-1005 is effective in reducing an acute NIHL in this affected population. In this Phase 2b study subjects with prior NIHL will be enrolled and exposed to a calibrated sound challenge (CSC) that induces a slight acute NIHL.
Detailed Description:
Randomized, double-blind, placebo-controlled, safety and efficacy study of oral SPI-1005 in adults with Noise Induced Hearing Loss (NIHL). All recruited subjects will have their severity of NIHL determined before the start of SPI-1005 treatment using various hearing tests. Subjects will be enrolled and randomized to either placebo or SPI-1005. Subjects will be dosed with either placebo or SPI-1005 for 7 days, beginning 1 day before an acute NIHL. Subjects will have hearing tests performed before and immediately after a calibrated sound challenge (CSC). Follow-up hearing tests will be performed post-CSC.
Study Oversight
Has Oversight DMC:
True
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?: