Status:
TERMINATED
Noise-Induced Hearing Loss-Acute Exposure Treatment
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
University of Texas
Gateway Biotechnology, Inc.
Conditions:
Hearing Loss, Noise-Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 risk...
Eligibility Criteria
Inclusion
- 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 25 decibel (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 4 kHz 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
- 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 the non-operated ear
- History of ototoxic drug use
- Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice
Key Trial Info
Start Date :
October 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04768569
Start Date
October 4 2021
End Date
September 29 2023
Last Update
January 15 2025
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110