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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 baseline prior to training

Awards & highlights

PINIHL-AET Trial Summary

This trial will test whether the drug zonisamide is safe and effective for treating hearing loss caused by noise in adults.

Eligible Conditions

Noise-Induced Hearing Loss

PINIHL-AET Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days (+/- 3 days) after training

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days (+/- 3 days) after training

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days (+/- 3 days) after training for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

The measure is the proportion of officers with permanent threshold shift (PTS)

Secondary outcome measures

Determine a link between noise induced hearing loss (NIHL) and zonisamide (ZNS) treatment effect as assessed by pharmacogenetic testing

Distortion product otoacoustic emissions (DPOAE)

Electrocochleography (ECochG)

+2 more

PINIHL-AET Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ZonisamideExperimental Treatment1 Intervention

For subjects randomized to zonisamide, the package will contain one zonisamide capsule (100 mg PO).

Group II: PlaceboPlacebo Group1 Intervention

For the subjects randomized to placebo, the package will contain one placebo capsule that looks, smells, and taste the same as zonisamide capsule.

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

24 Total Patients Enrolled

University of TexasOTHER

187 Previous Clinical Trials

142,415 Total Patients Enrolled

Washington University School of MedicineLead Sponsor

1,931 Previous Clinical Trials

2,299,945 Total Patients Enrolled

Frequently Asked Questions

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

What other research has been conducted regarding the efficacy of Zonisamide 100Mg Cap?

"Presently, there are 13 clinical trials underway analyzing the effects of Zonisamide 100Mg Cap. Of those studies, two have advanced to phase 3. Most tests for this pharmaceutical intervention take place in Edmonton, Alberta; however, 15 other medical centres are also running trial sites."

Answered by AI

What medical conditions is Zonisamide 100Mg Cap commonly prescribed to address?

"Zonisamide 100Mg Cap can provide relief from vaginal itching, a burning sensation in the vagina, and epileptic episodes."

Answered by AI

Is this medical experiment open to participants at the moment?

"This medical study is currently not taking on any new applicants. It was first posted in November 2021, and last edited at the end of that month. However, there are 164 different studies actively recruiting patients suffering from acoustic trauma as well as 13 trials involving Zonisamide 100Mg Cap."

Answered by AI

Has the FDA sanctioned Zonisamide 100Mg Cap for use?

"Our team has assessed the safety of Zonisamide 100Mg Cap to be a 2 due to Phase 2 trial data, which is suggestive of efficacy but not yet confirming it."

Answered by AI

What is the current sample size of this medical experiment?

"This research study is no longer recruiting. The trial was initially published on November 10th 2021, and amended for the last time on the 29th of that same month. If you're interested in other clinical trials related to acoustic trauma, there are presently 164 studies enrolling patients; 13 of which involve Zonisamide 100Mg Cap as a possible intervention."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)

2021. "Noise-Induced Hearing Loss-Acute Exposure Treatment (UA)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04774250.