Use of Modafinil in the Treatment of Tinnitus

• Status: Terminated
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Arkansas
• Treatments: Armodafinil; Modafinil

Criteria

Inclusion Criteria:

• 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

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 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

• 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