Use of Modafinil in the Treatment of Tinnitus
Stopped early · Phase 1 · Has a placebo group
Conditions studied: Tinnitus
In brief
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 vigilance.
Key facts
- Study ID
- NCT00591019
- Run by
- University of Arkansas
- People needed
- 7
- Starts
- 2006-08-01
- Expected to finish
- 2008-06-01
- Last updated by the study team
- 2015-10-08
Who can join
Age: 20 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- The diagnosis of tinnitus should be established by subject through exam and history performed by study physician in Ear, Nose and Throat (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 University of Arkansas for Medical Sciences (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.
- Hematologic (minimal values) at screening Absolute neutrophil count > 1,500 mm\^3 Hemoglobin > 8.0 g/dl Platelet count > 100,000 mm\^3
You may not qualify if…
- 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 Echo Cardiogram 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 anti hypertensive 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
Where it is running
- University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
Full record on ClinicalTrials.gov
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