Ignite Creation Date:
2025-12-24 @ 11:10 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT04768569
Status:
TERMINATED
Last Update Posted:
2025-01-15
First Post:
2020-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Noise-Induced Hearing Loss-Acute Exposure Treatment
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
Status:
TERMINATED
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PINIHL Program terminated by DoD
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PINIHL-AET
Brief Summary:
The purpose of this study is to assess the safety and efficacy of zonisamide for the treatment of noise-induced hearing loss in adults.
Detailed Description:
This study is a randomized, double-blinded placebo-control trial with three parallel groups, to make use of a common control group. After being informed about the study expectations and potential risks, all individuals providing written informed consent will undergo screening to determine eligibility for study entry.
Participants who meet the eligibility requirements will be randomized in a balanced fashion into one of 3 arms:
Group 1) Zonisamide 100 milligrams (mg) pre-op + Placebo post-op; Group 2) Placebo pre- + placebo post-op; and Group 3) Zonisamide 100 mg post-op + placebo post-op
Participants who meet the eligibility requirements will be randomized in a balanced fashion into one of 3 arms:
Group 1) Zonisamide 100 milligrams (mg) pre-op + Placebo post-op; Group 2) Placebo pre- + placebo post-op; and Group 3) Zonisamide 100 mg post-op + placebo post-op
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?: