NCT04768569

Noise-Induced Hearing Loss-Acute Exposure Treatment

Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Conditions

• Hearing Loss, Noise-Induced

Interventions

Type	Name	Description
DRUG	Zonisamide 100Mg Cap	ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
DRUG	Placebo	The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Timeline

• Start date: 2021-10-04
• Primary completion: 2023-09-29
• Completion: 2023-09-29
• First posted: 2021-02-24
• Last updated: 2025-01-15
• Results posted: 2025-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study