Noise-Induced Hearing Loss-Acute Exposure Treatment

Last updated: December 23, 2024
Sponsor: Washington University School of Medicine
Overall Status: Terminated

Phase

2

Condition

Hearing Impairment

Hearing Loss

Deafness

Treatment

Zonisamide 100Mg Cap

Placebo

Clinical Study ID

NCT04768569
PINIHL-AET
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are scheduled to undergo a skull-based surgery that requires at least 45 minutes of surgical-drilling

  • At least 18 years of age

  • Air conduction thresholds in the non-operated ears are to be no worse than 25decibel (dB) hearing loss (HL) for pure tone average 0.5, 1, and 2 kilohertz (kHz)with no individual threshold greater than 30 dB HL, and no worse than 45dB HL at 4kHz at screening.

  • Observed air-bone gap < 10 dB HL at 0.5, 1, 2, and 4 kHz, with normal tympanometry.

  • Ability to understand and willingness to sign an Institutional Review Board (IRB)approved written informed consent document.

Exclusion

Exclusion Criteria:

  • History of known sulfa allergy or hypersensitivity to carbonic anhydrase inhibitors

  • History of moderate-to-severe kidney or liver disease

  • Acute viral, bacterial, fungal or parasitic infection

  • History of seizures

  • Currently pregnant or breast-feeding

  • Any current or history of ear disorder and/or central auditory dysfunction in thenon-operated ear

  • History of ototoxic drug use

  • Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice

Study Design

Total Participants: 24
Treatment Group(s): 2
Primary Treatment: Zonisamide 100Mg Cap
Phase: 2
Study Start date:
October 04, 2021
Estimated Completion Date:
September 29, 2023

Study 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

Connect with a study center

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

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