Overview

Noise-Induced Hearing Loss-Acute Exposure Treatment

Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Washington University School of Medicine
Collaborators:
Gateway Biotechnology, Inc.
The University of Akron
United States Department of Defense
University of Texas
Treatments:
Zonisamide
Criteria
Inclusion Criteria:

- Scheduled to undergo a skull-based surgery that requires at least 1-hour of
surgical-drilling

- Air conduction thresholds in the non-operated ears are no worse than 25 decibel (dB)
hearing loss (HL) from 0.5 to 3 kilohertz (kHz), no worse than 30dB HL at 4kHz, and no
worse than 45dB HL at 6 and 8 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 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 the
non-operated ear

- History of ototoxic drug use

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