NCT04774250

Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (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 (ZNS) for the treatment of noise-induced hearing loss in adults.

Detailed description

This is a randomized, double-blind, and placebo-controlled study is to test whether zonisamide (ZNS) can treat noise-induced hearing loss in police officers on the range following training and certifications sessions. Participants who meet the eligibility requirements will be randomized to receive either ZNS 100 milligrams (mg) or placebo. Study participants will be recruited from the Akron Police Department, Summit County Police Department, and other local surrounding police departments. Police officers will be offered participation if they are training for firearm certification as part of their standard occupational requirements. These are officers that would be recommended and/or required to complete these trainings/certifications despite this investigation and this investigation will have no influence on audiologic recommendations. 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.

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: 2021-11-10
• Primary completion: 2022-12-23
• Completion: 2022-12-23
• First posted: 2021-03-01
• Last updated: 2026-02-13
• Results posted: 2025-09-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study