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Trial record 1 of 1 for:    NCT04768569
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Noise-Induced Hearing Loss-Acute Exposure Treatment (PINIHL-AET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04768569
Recruitment Status : Enrolling by invitation
First Posted : February 24, 2021
Last Update Posted : December 14, 2021
Sponsor:
Collaborators:
The University of Akron
University of Texas
Gateway Biotechnology, Inc.
United States Department of Defense
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Hearing Loss, Noise-Induced Drug: Zonisamide 100Mg Cap Drug: Placebo Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study is a randomized, double-blinded placebo-control trial with three parallel groups, to make use of a common control group.
Masking: Double (Participant, Investigator)
Masking Description:

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.

Primary Purpose: Prevention
Official Title: Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
Actual Study Start Date : October 4, 2021
Estimated Primary Completion Date : August 2024
Estimated Study Completion Date : December 2024


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 Name: 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 Name: 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 Name: microcrystalline cellulose




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04768569


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
The University of Akron
University of Texas
Gateway Biotechnology, Inc.
United States Department of Defense
Investigators
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Principal Investigator: Craig A Buchman, MD, FACS Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04768569    
Other Study ID Numbers: PINIHL-AET
First Posted: February 24, 2021    Key Record Dates
Last Update Posted: December 14, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Noise-Induced
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Hearing Loss, Sensorineural
Zonisamide
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs