Use of Modafinil in the Treatment of Tinnitus
Information source: University of Arkansas
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tinnitus
Intervention: Modafinil (Drug); Placebo (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University of Arkansas Official(s) and/or principal investigator(s):
John L Dornhoffer, MD, Principal Investigator, Affiliation: University of Arkansas
Overall contact:
Jeff Myhill, MD, Phone: 501-526-7171, Email: jamyhill@uams.edu
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
tinnitus symptoms and vigilance.
Clinical Details
Official title: Use of Modafinil in the Treatment of Tinnitus
Study design: Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: 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.
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
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Jeff Myhill, MD, Phone: 501-526-7171, Email: jamyhill@uams.edu
University of Arkansas for Medical Sciences, Little Rock, Arkansas 72205, United States; Recruiting
Jeff Myhill, MD, Phone: 501-526-7171, Email: jamyhill@uams.edu
John L Dornhoffer, MD, Principal Investigator
Additional Information
Starting date: August 2006
Ending date: August 2008
Last updated: January 10, 2008
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