Noise-Induced Hearing Loss-Acute Exposure Treatment

Hearing Loss, Noise-Induced Clinical Trial

— PINIHL-AET  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04768569
• Other study ID #: PINIHL-AET
• Status: Terminated
• Phase: Phase 2
• Start date: October 4, 2021
• Est. completion date: September 29, 2023

Study information

• Verified date: October 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: September 29, 2023
• Est. primary completion date: September 29, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Noise-Induced

Intervention

Drug:
• Zonisamide 100Mg Cap
ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
• Placebo
The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	Gateway Biotechnology, Inc., United States Department of Defense, University of Texas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of PTS-positive subjects	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	The rate of distortion product otoacoustic emissions (DPOAE) shift	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