Use of Modafinil in the Treatment of Tinnitus

This study has been terminated.

( Terminated early due to lack of change in primary and secondary outcome measures. )

Study NCT00591019 Information provided by University of Arkansas

First Received on December 27, 2007. Last Updated on September 29, 2011 History of Changes

Results First Received: February 28, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Crossover Assignment; Masking: Single Blind (Subject); Primary Purpose: Treatment
Condition:	Tinnitus
Interventions:	Drug: Modafinil Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients recruited from treatment clinic, seeking treatment for tinnitus.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
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.

Participant Flow for 3 periods

Period 1: Baseline (1 Day)

	Baseline, Modafinil 200 mg/Day, Placebo	Baseline, Placebo, Modafinil 200 mg/Day
STARTED	3	4
COMPLETED	3	4
NOT COMPLETED	0	0

Period 2: Intervention 1 (14 Days)

	Baseline, Modafinil 200 mg/Day, Placebo	Baseline, Placebo, Modafinil 200 mg/Day
STARTED	2 ^[1]	3 ^[1]
COMPLETED	2	3
NOT COMPLETED	0	0

[1]	One subject dropped out after baseline

Period 3: Intevention 2 (14 Days)

	Baseline, Modafinil 200 mg/Day, Placebo	Baseline, Placebo, Modafinil 200 mg/Day
STARTED	2	3
COMPLETED	2	3
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
All Participants	Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.

Baseline Measures

	All Participants
Number of Participants [units: participants]	7
Age [units: participants]
<=18 years	0
Between 18 and 65 years	7
>=65 years	0
Age [units: years] Mean ± Standard Deviation	55 ± 2
Gender [units: participants]
Female	2
Male	5
Region of Enrollment [units: participants]
United States	7

Outcome Measures

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1. Primary:

The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). [ Time Frame: 5 weeks ]

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2. Secondary:

Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. [ Time Frame: 5 weeks ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Study was terminated early due to lack of change in primary and secondary outcome measures.

Results Point of Contact:

Name/Title: Dr John Dornhoffer
Organization: University of Arkansas for Medical Sciences (UAMS)
phone: 501 686-5140
e-mail: dornhofferjohnl@uams.edu

No publications provided

Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00591019 History of Changes
Other Study ID Numbers:	# 65171
Study First Received:	December 27, 2007
Results First Received:	February 28, 2011
Last Updated:	September 29, 2011
Health Authority:	United States: Food and Drug Administration