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NCT00591019 · ClinicalTrials.gov registry record · Phase 1

Use of Modafinil in the Treatment of Tinnitus

A Phase 1 study, sponsored by University of Arkansas.

Terminated
Registry status
Phase 1
Development phase
7
Enrollment target

NCT00591019: Clinical Trial Phase 1 study, sponsored by University of Arkansas.

NCT00591019 is a Phase 1 study that was terminated before completion, run by University of Arkansas. The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00591019, a Phase 1 study, was terminated before completion, sponsored by University of Arkansas.

TERMINATED
Registry status
Phase 1
Development phase
7 participants
Enrollment target

Study Summary

A study on the effects of the FDA approved drug Modafinil upon attention problems associated with tinnitus. This is considered to be a safe drug with few side effects. Each subject will be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive testing and recordings will be taken. The study involves each subject taking a 2- week supply of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving vigilance.

Primary Outcome

P50 is an auditory evoked response potential sensitive to states of arousal.

Interventions

  • OTHER Placebo
  • DRUG Modafinil

Trial Details

FieldValue
Enrollment Target 7 participants
Start Date 2006-08
Est. Completion 2008-06
Phase Phase 1
University of Arkansas

318 total trials

Why NCT00591019 stopped before completion

NCT00591019 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).

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

NCT00591019 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00591019 about?

NCT00591019 is a clinical study titled "Use of Modafinil in the Treatment of Tinnitus". A study on the effects of the FDA approved drug Modafinil upon attention problems associated with tinnitus. This is considered to be a safe drug with few side effects. Each subject will be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive testing and recordings ...

What is the current status of trial NCT00591019?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2006-08. Estimated completion is 2008-06.

What interventions are being tested in trial NCT00591019?

The interventions under investigation include: Placebo (OTHER), Modafinil (DRUG).

Who is sponsoring clinical trial NCT00591019?

This trial is sponsored by University of Arkansas, which has 318 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00591019's enrollment target sits among peer trials

7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00591019, the US trial registry maintained by the National Library of Medicine. NCT00591019 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.