Trial · NCT00591019
Use of Modafinil in the Treatment of Tinnitus
NCT00591019, Phase 1, Terminated, University of Arkansas; results first posted 2011-05-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Use of Modafinil in the Treatment of Tinnitus. Trials, record NCT00591019. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00591019
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Use of Modafinil in the Treatment of Tinnitus
- NCT number
- NCT00591019
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 7 participants, actual
- Lead sponsor
- University of Arkansas
- Conditions
- Tinnitus
- Interventions
- Modafinil, Placebo
- First posted
- 2008-01-11
- Last updated
- 2015-10-08
- Results first posted
- 2011-05-09
- Limitations and caveats
- Study was terminated early due to lack of change in primary and secondary outcome measures.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | 5 weeks | P50 is an auditory evoked response potential sensitive to states of arousal. |
| Secondary | Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | 5 weeks | Simple reaction time to an auditory signal is a measure of attention. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | 5 weeks | milli volts | MEAN | |
| SECONDARY | Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | 5 weeks | milli seconds | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | Baseline Testing. | 1.25 | Standard Error .15 | milli volts | |
| The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | Modafinil | 1.47 | Standard Error .28 | milli volts | |
| The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). | Placebo | 1.23 | Standard Error .26 | milli volts | |
| Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | Baseline Testing. | 269.80 | Standard Error 12.64 | milli seconds | |
| Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | Modafinil | 268.12 | Standard Error 14.41 | milli seconds | |
| Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. | Placebo | 247.11 | Standard Error 8.14 | milli seconds |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline (1 Day) | STARTED | Baseline, Modafinil 200 mg/Day, Placebo | 3 | |
| Baseline (1 Day) | STARTED | Baseline, Placebo, Modafinil 200 mg/Day | 4 | |
| Baseline (1 Day) | COMPLETED | Baseline, Modafinil 200 mg/Day, Placebo | 3 | |
| Baseline (1 Day) | COMPLETED | Baseline, Placebo, Modafinil 200 mg/Day | 4 | |
| Baseline (1 Day) | NOT COMPLETED | Baseline, Modafinil 200 mg/Day, Placebo | 0 | |
| Baseline (1 Day) | NOT COMPLETED | Baseline, Placebo, Modafinil 200 mg/Day | 0 | |
| Intervention 1 (14 Days) | STARTED | Baseline, Modafinil 200 mg/Day, Placebo | 2 | |
| Intervention 1 (14 Days) | STARTED | Baseline, Placebo, Modafinil 200 mg/Day | 3 | |
| Intervention 1 (14 Days) | COMPLETED | Baseline, Modafinil 200 mg/Day, Placebo | 2 | |
| Intervention 1 (14 Days) | COMPLETED | Baseline, Placebo, Modafinil 200 mg/Day | 3 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Baseline Testing. | ||
| Total, all-cause mortality | Modafinil | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Baseline Testing. | 0 | 7 |
| Total, other adverse events | Modafinil | 0 | 7 |
| Total, other adverse events | Placebo | 0 | 7 |
| Total, serious adverse events | Baseline Testing. | 0 | 7 |
| Total, serious adverse events | Modafinil | 0 | 7 |
| Total, serious adverse events | Placebo | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Simple Reaction Time | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00591019
GET https://conductscience.org/api/trials/v1/NCT00591019/registered