Hearing Loss, Noise-InducedPhase 2PINIHL-AETNCT04768569
Noise-Induced Hearing Loss-Acute Exposure Treatment
A Phase 2 study testing Zonisamide 100Mg Cap in people with Hearing Loss, Noise-Induced, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hearing Loss, Noise-Induced
- What is being tested?
- Zonisamide 100Mg Cap
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 29 Sep 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
Read the 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
- Conditions
- Hearing Loss, Noise-Induced
- Being tested
- Zonisamide 100Mg Cap, Placebo
- Medical subject headings
- Hearing Loss, Noise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zonisamide 100Mg CapDrug
Also called Zonegran, ZNS
ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
PlaceboDrug
Also called microcrystalline cellulose
The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.
| Study group | Role | What they receive |
|---|---|---|
| Zonisamide Pre-op + Placebo Post-op | Active comparator | 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. Receives: Drug: Zonisamide 100Mg Cap; Drug: Placebo |
| Placebo Pre-op + Placebo Post-op | Placebo comparator | 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. Receives: Drug: Placebo |
| Placebo Pre-op + Zonisamide Post-op | Active comparator | 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). Receives: Drug: Zonisamide 100Mg Cap; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days
Secondary outcomes (1)
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start4 Oct 2021
- Primary completion29 Sep 2023
- Study completion29 Sep 2023
Why it stopped: PINIHL Program terminated by DoD
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hearing Loss, Noise-InducedStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Gateway Biotechnology, Inc., United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Craig A Buchman, MD, FACS, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768569
- Sponsor's protocol ID
- PINIHL-AET
- Acronym
- PINIHL-AET
- Status last verified
- Dec 2024
- First submitted
- 4 Dec 2020
- Last updated
- 15 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmaceutical Interventions for Noise-Induced Hearing Loss-Acute Exposure Treatment
- ClinicalTrials.gov ID
- NCT04768569
- Acronym / sponsor ID
- PINIHL-AET / PINIHL-AET
- Conditions
- Hearing Loss, Noise-Induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PINIHL Program terminated by DoD
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Texas, Gateway Biotechnology, Inc., United States Department of Defense
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 29 Sep 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 24 Feb 2021 (actual)
- Results
- Posted 15 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This study is a randomized, double-blinded placebo-control trial with three parallel groups, to make use of a common control group.
| Arm | Type | Receives |
|---|---|---|
| Zonisamide Pre-op + Placebo Post-op | Active comparator | Drug: Zonisamide 100Mg Cap, Drug: PlaceboFor 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. |
| Placebo Pre-op + Placebo Post-op | Placebo comparator | Drug: PlaceboFor 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. |
| Placebo Pre-op + Zonisamide Post-op | Active comparator | Drug: Zonisamide 100Mg Cap, Drug: PlaceboFor 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zonisamide 100Mg CapAlso: Zonegran, ZNSZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide. | Drug | Placebo Pre-op + Zonisamide Post-op, Zonisamide Pre-op + Placebo Post-op |
| PlaceboAlso: microcrystalline celluloseThe placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule. | Drug | Placebo Pre-op + Placebo Post-op, Placebo Pre-op + Zonisamide Post-op, Zonisamide Pre-op + Placebo Post-op |
Primary outcome
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.
1 secondary outcome
The Rate of Distortion Product Otoacoustic Emissions (DPOAE) Shift
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss, Noise-Induced
Not yet recruitingObservational study
OCCUPATIONAL NOISE AND CHEMICAL EXPOSURE EFFECTS ON AUDITORY AND VESTIBULAR FUNCTION
Occupational Noise Exposure
Not yet recruiting
Intervention for Hearing Health Among Native Americans
Noise-Induced Hearing Loss
Enrolling by invitation
Comparative Efficacy of Earplug Usage Instruction
Noise-Induced Hearing Loss, Hearing Protection Device Use
Recruiting
Non-Invasive System to Deliver Therapeutic Hypothermia for Protection Against Noise-Induced Hearing Loss
Noise Exposure, Noise-induced Hearing Loss
RecruitingPhase 1/2
A Treatment for a Form of Age-Related Central Auditory Processing Disorder Consisting of Clemastine Fumarate Plus Engineered Sound
Central Auditory Processing Disorder, Hearing Impaired (Partially)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig A Buchman, MD, FACS principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Zonisamide 100Mg Cap in people with Hearing Loss, Noise-Induced, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ratio of PTS-positive Subjects (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.