Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Hearing Loss, Noise-Induced

In brief

The purpose of this study is to assess the safety and efficacy of zonisamide (ZNS) for the treatment of noise-induced hearing loss in adults.

Key facts

Study ID

NCT04774250

Run by

Washington University School of Medicine

People needed

3

Starts

2021-11-10

Expected to finish

2022-12-23

Last updated by the study team

2026-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• 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 otologic disorder.
• History of ototoxic drug use.
• Current use of strong/moderate 3A4 inhibitor/inducer and grapefruit juice.
• For secondary outcomes, exclusion criteria is as follows:
• DPOAE data will be used as a secondary outcome measure of TTS, and participants will be excluded if their DPOAE is absent at more than 3/7 frequencies. Criteria for a present response is any response that is > 5 dB SPL above the noise floor and replicable within ±5 dB SPL.
• ECochG: Participants will be excluded if the ECochG/ABR wave I response is absent.
• WIN test: Participants with WIN scores greater than moderate difficulty or 14.9 dB SNR will be excluded.

Where it is running

• University of Akron — Akron, Ohio, United States

Full record on ClinicalTrials.gov

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