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

October 4, 2023 updated by: Washington University School of Medicine

Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Drug: Zonisamide 100Mg Cap
ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
Other Names:
  • Zonegran
  • ZNS
Drug: Placebo
The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.
Other Names:
  • microcrystalline cellulose
Placebo Comparator: 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.
Drug: Placebo
The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.
Other Names:
  • microcrystalline cellulose
Active Comparator: 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).
Drug: Zonisamide 100Mg Cap
ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
Other Names:
  • Zonegran
  • ZNS
Drug: Placebo
The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.
Other Names:
  • microcrystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ratio of PTS-positive subjects
Time Frame: 30 days
The primary efficacy endpoint will be the proportion of PTS-positive subjects defined as the ratio of PTS-positive subjects to total number of subjects within each study arm/group. Subjects defined as PTS-positive will demonstrate an increase in threshold that is ≥10 dB HL at any frequency from 2-6 kHz post-surgery as compared to baseline audiogram.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of distortion product otoacoustic emissions (DPOAE) shift
Time Frame: 30 days
The secondary efficacy outcome measures will be the rate of temporary cochlear change as measured by a DPOAE amplitude shift at any frequency that is significantly greater than the stability of each measurement (i.e., 95% confidence interval of each measurement do not overlap). The rate of DPOAE shift is the ratio of DPOAE shift-positive subjects to total subjects within each arm.
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

United States Department of Defense
University of Texas
Gateway Biotechnology, Inc.

Investigators

  • Principal Investigator: Craig A Buchman, MD, FACS, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 4, 2021

Primary Completion (Actual)

September 29, 2023

Study Completion (Actual)

September 29, 2023

Study Registration Dates

First Submitted

December 4, 2020

First Submitted That Met QC Criteria

February 23, 2021

First Posted (Actual)

February 24, 2021

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PINIHL-AET

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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