Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Use of Modafinil in the Treatment of Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Tinnitus
Interventions Drug: Modafinil
Other: Placebo
Enrollment 7
Recruitment Details Patients recruited from treatment clinic, seeking treatment for tinnitus.
Pre-assignment Details  
Arm/Group Title Baseline, Modafinil 200 mg/Day, Placebo Baseline, Placebo, Modafinil 200 mg/Day
Hide Arm/Group Description Subjects are tested at baseline, then after Modafinil (200mg/day, a.m. administration) for 14 days, then after placebo (for 14 days). Subjects are tested after baseline, then after taking a sugar pill once per day in the morning for 14 days, and then after taking modafinil 200 mg/day for 14 days.
Period Title: Baseline (1 Day)
Started 3 4
Completed 3 4
Not Completed 0 0
Period Title: Intervention 1 (14 Days)
Started 2 [1] 3 [1]
Completed 2 3
Not Completed 0 0
[1]
One subject dropped out after baseline
Period Title: Intevention 2 (14 Days)
Started 2 3
Completed 2 3
Not Completed 0 0
Arm/Group Title All Participants
Hide Arm/Group Description Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.
Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
55  (2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
2
  28.6%
Male
5
  71.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
1.Primary Outcome
Title The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).
Hide Description P50 is an auditory evoked response potential sensitive to states of arousal.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Testing. Modafinil Placebo
Hide Arm/Group Description:
Establish baseline levels of performance
Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
Overall Number of Participants Analyzed 5 5 5
Mean (Standard Error)
Unit of Measure: milli volts
1.25  (.15) 1.47  (.28) 1.23  (.26)
2.Secondary Outcome
Title Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.
Hide Description Simple reaction time to an auditory signal is a measure of attention.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Baseline Testing. Modafinil Placebo
Hide Arm/Group Description:
Establish baseline levels of performance
Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
Overall Number of Participants Analyzed 5 5 5
Mean (Standard Error)
Unit of Measure: milli seconds
269.80  (12.64) 268.12  (14.41) 247.11  (8.14)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Baseline Testing. Modafinil Placebo
Hide Arm/Group Description Establish baseline levels of performance Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days. Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
All-Cause Mortality
Baseline Testing. Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Baseline Testing. Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Baseline Testing. Modafinil Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/7 (0.00%)   0/7 (0.00%)   0/7 (0.00%) 
Study was terminated early due to lack of change in primary and secondary outcome measures.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr John Dornhoffer
Organization: University of Arkansas for Medical Sciences (UAMS)
Phone: 501 686-5140
EMail: dornhofferjohnl@uams.edu
Layout table for additonal information
Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00591019     History of Changes
Other Study ID Numbers: # 65171
First Submitted: December 27, 2007
First Posted: January 11, 2008
Results First Submitted: February 28, 2011
Results First Posted: May 9, 2011
Last Update Posted: October 8, 2015