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Use of Modafinil in the Treatment of Tinnitus
This study has been completed.
Study NCT00591019   Information provided by University of Arkansas
First Received: December 27, 2007   Last Updated: September 12, 2008   History of Changes

December 27, 2007
September 12, 2008
August 2006
March 2008   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00591019 on ClinicalTrials.gov Archive Site
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 ]
Same as current
 
Use of Modafinil in the Treatment of Tinnitus
Use of Modafinil in the Treatment of Tinnitus

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.

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).

 
Interventional
Treatment, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Efficacy Study
Tinnitus
  • Drug: Modafinil
  • Drug: Placebo
  • Experimental: The drug group will be instructed to take Modafinil (200mg/day taken in the morning) for 14 days.
  • Placebo Comparator: The placebo group will be instructed to take a 14 days' supply of placebo.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
10
June 2008
March 2008   (final data collection date for primary outcome measure)

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
Both
20 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00591019
John L. Dornhoffer, MD, University of Arkansas for Medical Sciences
# 65171
University of Arkansas
 
Principal Investigator: John L Dornhoffer, MD University of Arkansas
University of Arkansas
September 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP