Noise-Induced Hearing Loss-Acute Exposure Treatment (PINIHL-AET)

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Hearing Loss, Noise-Induced

Treatments: Drug: Zonisamide 100Mg Cap; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry; Other U.S. Federal agency

Identifiers

NCT04768569

PINIHL-AET

Details and patient eligibility

About

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

Full 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

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Zonisamide Pre-op + Placebo Post-op

Active Comparator group

Description:

For subjects randomized to zonisamide pre-op, the pre-op package will contain one zonisamide capsule (100 mg PO) and the post-op package will contain one placebo capsule that looks, smells, and tastes the same as zonisamide capsules.

Treatment:

Drug: Placebo

Drug: Zonisamide 100Mg Cap

Placebo Pre-op + Placebo Post-op

Placebo Comparator group

Description:

For the subjects randomized to placebo, both pre- and post-op packages will contain placebo capsules that looks, smells, and taste the same as zonisamide capsules.

Treatment:

Drug: Placebo

Placebo Pre-op + Zonisamide Post-op

Active Comparator group

Description:

For subjects randomized to zonisamide post-op, the pre-op package will contain one placebo capsule and the post-op package will contain one zonisamide capsule (100 mg PO).

Treatment:

Drug: Placebo

Drug: Zonisamide 100Mg Cap