Noise-Induced Hearing Loss-Acute Exposure Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-04

Study Completion Date

2023-09-29

Brief Summary

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

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Detailed Description

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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

Conditions

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Hearing Loss, Noise-Induced

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized, double-blinded placebo-control trial with three parallel groups, to make use of a common control group.

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Subjects will be randomized in a balanced fashion into one of 3 arms: Zonisamide 100 mg pre-op, Placebo, or Zonisamide 100 mg post-op.

To ensure double-blinding of the trial, each subject will be assigned a previously prepared envelope with one package labeled "1" and designated to be taken 4 hours prior to surgery and another package labeled "2" designated to be taken within 4-12 hours after surgery or when the patient is released clinically to oral medication.

Study Groups

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Zonisamide Pre-op + Placebo Post-op

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.

Group Type ACTIVE_COMPARATOR

Zonisamide 100Mg Cap

Intervention Type DRUG

ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.

Placebo

Intervention Type DRUG

The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Placebo Pre-op + Placebo Post-op

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Placebo Pre-op + Zonisamide Post-op

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).

Group Type ACTIVE_COMPARATOR

Zonisamide 100Mg Cap

Intervention Type DRUG

ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.

Placebo

Intervention Type DRUG

The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Interventions

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Zonisamide 100Mg Cap

ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.

Intervention Type DRUG

Placebo

The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Intervention Type DRUG

Other Intervention Names

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Zonegran ZNS microcrystalline cellulose

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes