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