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Anti-epileptic drug

Zonisamide 100Mg Cap for Noise-Induced Hearing Loss (PINIHL-AET Trial)

Phase 2

Waitlist Available

Led By Craig A Buchman, MD, FACS

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

PINIHL-AET Trial Summary

This trial will test if zonisamide is safe and effective for treating noise-induced hearing loss in adults.

Eligible Conditions

Noise-Induced Hearing Loss

PINIHL-AET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Platinum

Secondary outcome measures

The rate of distortion product otoacoustic emissions (DPOAE) shift

PINIHL-AET Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: Placebo Pre-op + Zonisamide Post-opActive Control2 Interventions

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).

Group II: Zonisamide Pre-op + Placebo Post-opActive Control2 Interventions

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.

Group III: Placebo Pre-op + Placebo Post-opPlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gateway Biotechnology, Inc.Industry Sponsor

2 Previous Clinical Trials

38 Total Patients Enrolled

The University of AkronOTHER

9 Previous Clinical Trials

861 Total Patients Enrolled

University of TexasOTHER

187 Previous Clinical Trials

142,429 Total Patients Enrolled

Media Library

Zonisamide (Anti-epileptic drug) Clinical Trial Eligibility Overview. Trial Name: NCT04768569 — Phase 2

Noise-Induced Hearing Loss Research Study Groups: Placebo Pre-op + Placebo Post-op, Placebo Pre-op + Zonisamide Post-op, Zonisamide Pre-op + Placebo Post-op

Noise-Induced Hearing Loss Clinical Trial 2023: Zonisamide Highlights & Side Effects. Trial Name: NCT04768569 — Phase 2

Zonisamide (Anti-epileptic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04768569 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other investigations have been conducted regarding this intervention?

"Currently, 13 studies are being conducted examining the efficacy of this treatment. Of these trials, 2 have moved into Phase 3 testing with most based in Edmonton, Alberta and 15 sites across the region participating in various stages."

Answered by AI

Has this therapy been authorized by the government for public use?

"This prospective therapy has been assigned a safety score of 2 on the Power scale, due to a lack of efficacy data but some corroborating evidence for its security."

Answered by AI

How many participants will be recruited for this research initiative?

"At present, this trial is not looking to recruit any new patients. The research was initially posted on October 4th 2021 and the data has most recently been updated on November 29th 2021. If you are seeking alternative studies there exist 164 clinical trials admiting participants with acoustic trauma as well as 13 investigations for related treatments that are presently enrolling volunteers."

Answered by AI

In what way is this particular treatment typically employed?

"This treatment has proven effective at alleviating symptoms of vaginal itching, burning sensations in the vagina and epileptic episodes."

Answered by AI

Is this empirical research available to participants currently?

"At present, this clinical trial is not enrolling any new patients. It was first made public on the 4th of October 2021 and last modified on November 29th 2021. For those seeking other trials, there are 164 studies in search for individuals suffering from acoustic trauma and 13 more recruiting participants to test out this specific treatment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Noise-Induced Hearing Loss-Acute Exposure Treatment

2021. "Noise-Induced Hearing Loss-Acute Exposure Treatment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04768569.