Clinical trial NCT04768569: Noise-Induced Hearing Loss-Acute Exposure Treatment
Official title: Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hearing Loss, Noise-Induced
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Texas
name: Gateway Biotechnology, Inc.
name: United States Department of Defense
First posted: 2021-02-24
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: The Ratio of PTS-positive Subjects
timeFrame: 30 days
Secondary outcomes:
measure: The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift
timeFrame: 30 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Craig A Buchman, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References: