Use of Modafinil in the Treatment of Tinnitus - Full Text View

Sponsor:	University of Arkansas
Information provided by:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00591019

Purpose

A study on the effects of the FDA approved drug Modafinil upon attention problems associated with tinnitus. This is considered to be a safe drug with few side effects. Each subject will be asked to participate in 3 sessions each lasting approximately 1 hour in which cognitive testing and recordings will be taken. The study involves each subject taking a 2- week supply of Modafinil and a 2- week supply of placebo. We hypothesize inattention related to thalamocortical dysrhythmia found in tinnitus can be reduced by Modafinil thus improving tinnitus symptoms and vigilance.

Condition	Intervention
Tinnitus	Drug: Modafinil Drug: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Use of Modafinil in the Treatment of Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Data from each subject on Modafinil will be compared to his/her data when placed on placebo in an effort to determine the differences in level of arousal with and without drug. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Data from each subject on Modafinil will be compared to his/her data when placed on placebo in an effort to determine the differences in level of habituation, and reaction time performance with and without drug. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	August 2006
Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The drug group will be instructed to take Modafinil (200mg/day taken in the morning) for 14 days.	Drug: Modafinil Modafinil (200mg/day taken in the morning) for 14 days.
2: Placebo Comparator The placebo group will be instructed to take a 14 days' supply of placebo.	Drug: Placebo Placebo sugar pill taken in morning for 14 days.

Detailed Description:

Modafinil, a drug primarily used in the treatment for narcolepsy, is also being using in treating attention problems found in Attention Deficit Hyperactive Disorder (ADHD). This study will investigate the efficacy of Modafinil upon attention deficits found in tinnitus patients by assessing pre-attentional and attentional processes in alleviating some of the symptoms associated with tinnitus (e.g., attention deficits, sleep disturbance, mood affect, and/or depression).

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

The diagnosis of tinnitus should be established by subject through exam and history performed by study physician in ENT clinic.
Subjects will be age 20 or older.
Subjects should have tinnitus symptoms severe enough to seek medical attention.
Subjects will have been seen in the Hearing and Balance Center at UAMS.
Subjects will have had an audiogram.
Signed informed consent.
Women of childbearing potential must have a negative pregnancy test at screening and before being prescribed the study drug.
Peripheral neuropathy: must be < grade 1 according to NCI CTC version 3 guidelines (Appendix B).
Hematologic (minimal values) at screening Absolute neutrophil count > 1,500/mm3 Hemoglobin > 8.0 g/dl Platelet count > 100,000/mm3

Exclusion Criteria:

Disease-Specific Concerns

Subjects who have locally advanced breast cancer with skin ulceration will be excluded from this study due to the risk of worsening ulcers and healing difficulties
Stage IV breast cancer
Inflammatory breast cancer

General Medical Concerns

Subjects with ECOG performance status 2, 3, and 4 are not eligible for this study
Allergy to any component of the treatment regimen
Women who are breast feeding
Pregnancy or refusal to use effective contraception while participating in this study
Inability to comply with study and/or follow-up procedures
Subjects with secondary malignancy other than superficial skin cancer (squamous cell carcinoma and basal cell carcinoma of the skin) should be excluded

Bevacizumab-Specific Concerns

Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
Blood pressure of > 150/100 mmHg. Essential hypertension well controlled with antihypertensive is not an exclusion criterion
Unstable angina
New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)
History of myocardial infarction within 6 months
History of stroke within 6 months
Clinically significant peripheral vascular disease
Evidence of bleeding diathesis or coagulopathy
Presence of central nervous system or brain metastases
Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
Pregnant (positive pregnancy test) or lactating
Urine protein: creatinine ratio >1.0 at screening
History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
Serious, non-healing wound, ulcer, or bone fracture

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591019

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

John L Dornhoffer, MD

University of Arkansas

More Information

No publications provided

Responsible Party:	University of Arkansas for Medical Sciences ( John L. Dornhoffer, MD )
Study ID Numbers:	# 65171
Study First Received:	December 27, 2007
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00591019 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arkansas:

Tinnitus, PVT, Habituation, Reaction Time

Additional relevant MeSH terms:

Sensation Disorders
Otorhinolaryngologic Diseases
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Stimulants
Protective Agents
Neuroprotective Agents
Tinnitus

Ear Diseases
Modafinil
Pharmacologic Actions
Signs and Symptoms
Hearing Disorders
Therapeutic Uses
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010