Trial Outcomes & Findings for Use of Modafinil in the Treatment of Tinnitus (NCT NCT00591019)

NCT ID: NCT00591019

Last Updated: 2015-10-08

Results Overview

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

• Recruitment status: TERMINATED
• Study phase: PHASE1
• Target enrollment: 7 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2015-10-08

Participant Flow

Patients recruited from treatment clinic, seeking treatment for tinnitus.

Participant milestones

Measure	Baseline, Modafinil 200 mg/Day, Placebo Subjects are tested at baseline, then after Modafinil (200mg/day, a.m. administration) for 14 days, then after placebo (for 14 days).	Baseline, Placebo, Modafinil 200 mg/Day 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.
Baseline (1 Day) STARTED	3	4
Baseline (1 Day) COMPLETED	3	4
Baseline (1 Day) NOT COMPLETED	0	0
Intervention 1 (14 Days) STARTED	2	3
Intervention 1 (14 Days) COMPLETED	2	3
Intervention 1 (14 Days) NOT COMPLETED	0	0
Intevention 2 (14 Days) STARTED	2	3
Intevention 2 (14 Days) COMPLETED	2	3
Intevention 2 (14 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Modafinil in the Treatment of Tinnitus

Baseline characteristics by cohort

Measure	All Participants n=7 Participants Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 2 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 weeks

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

Outcome measures

Measure	Baseline Testing. n=5 Participants Establish baseline levels of performance	Modafinil n=5 Participants Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.	Placebo n=5 Participants Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).	1.25 milli volts Standard Error .15	1.47 milli volts Standard Error .28	1.23 milli volts Standard Error .26

SECONDARY outcome

Timeframe: 5 weeks

Simple reaction time to an auditory signal is a measure of attention.

Outcome measures

Measure	Baseline Testing. n=5 Participants Establish baseline levels of performance	Modafinil n=5 Participants Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.	Placebo n=5 Participants Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.	269.80 milli seconds Standard Error 12.64	268.12 milli seconds Standard Error 14.41	247.11 milli seconds Standard Error 8.14

Adverse Events

Baseline Testing.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Modafinil

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr John Dornhoffer

University of Arkansas for Medical Sciences (UAMS)

Phone: 501 686-5140

Email: dornhofferjohnl@uams.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place