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NCT04768569 · ClinicalTrials.gov registry record · Phase 2

Noise-Induced Hearing Loss-Acute Exposure Treatment

A Phase 2 study, sponsored by Washington University School of Medicine.

Terminated
Registry status
Phase 2
Development phase
24
Enrollment target

NCT04768569: Clinical Trial Phase 2 study, sponsored by Washington University School of Medicine.

NCT04768569 is a Phase 2 study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04768569, a Phase 2 study, was terminated before completion, sponsored by Washington University School of Medicine.

TERMINATED
Registry status
Phase 2
Development phase
24 participants
Enrollment target

Study 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.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Zonisamide 100Mg Cap

Trial Details

FieldValue
Enrollment Target 24 participants
Start Date 2021-10-04
Est. Completion 2023-09-29
Phase Phase 2

Why NCT04768569 stopped before completion

NCT04768569 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04768569 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04768569 about?

NCT04768569 is a clinical study titled "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.

What is the current status of trial NCT04768569?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2021-10-04. Estimated completion is 2023-09-29.

What interventions are being tested in trial NCT04768569?

The interventions under investigation include: Placebo (DRUG), Zonisamide 100Mg Cap (DRUG).

Who is sponsoring clinical trial NCT04768569?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04768569's enrollment target sits among peer trials

24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04768569, the US trial registry maintained by the National Library of Medicine. NCT04768569 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.