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Noise-Induced Hearing Loss-Acute Exposure Treatment

NCT04768569 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-01-15

Study results available
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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.

Conditions

  • Hearing Loss, Noise-Induced

Interventions

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.

Sponsors & Collaborators

  • University of Texas

    collaborator OTHER

  • Gateway Biotechnology, Inc.

    collaborator INDUSTRY

  • United States Department of Defense

    collaborator FED

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Craig A Buchman, MD, FACS · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-04
Primary Completion
2023-09-29
Completion
2023-09-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768569 on ClinicalTrials.gov