Use of Modafinil in the Treatment of Tinnitus
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|ClinicalTrials.gov Identifier: NCT00591019|
Recruitment Status : Terminated (Terminated early due to lack of change in primary and secondary outcome measures.)
First Posted : January 11, 2008
Results First Posted : May 9, 2011
Last Update Posted : October 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Drug: Modafinil Other: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||7 participants|
|Official Title:||Use of Modafinil in the Treatment of Tinnitus|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||June 2008|
|Active Comparator: modafinil||
200 mg/day, morning dose
|Placebo Comparator: Placebo||
Sugar pill once per day in the morning.
- The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). [ Time Frame: 5 weeks ]P50 is an auditory evoked response potential sensitive to states of arousal.
- Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. [ Time Frame: 5 weeks ]Simple reaction time to an auditory signal is a measure of attention.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591019
|United States, Arkansas|
|University of Arkansas for Medical Sciences|
|Little Rock, Arkansas, United States, 72205|
|Principal Investigator:||John L Dornhoffer, MD||University of Arkansas|