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Use of Modafinil in the Treatment of Tinnitus

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ClinicalTrials.gov Identifier: NCT00591019
Recruitment Status : Terminated (Terminated early due to lack of change in primary and secondary outcome measures.)
First Posted : January 11, 2008
Results First Posted : May 9, 2011
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Tracking Information
First Submitted Date  ICMJE December 27, 2007
First Posted Date  ICMJE January 11, 2008
Results First Submitted Date  ICMJE February 28, 2011
Results First Posted Date  ICMJE May 9, 2011
Last Update Posted Date October 8, 2015
Study Start Date  ICMJE August 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). [ Time Frame: 5 weeks ]
P50 is an auditory evoked response potential sensitive to states of arousal.
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
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 ]
Change History Complete list of historical versions of study NCT00591019 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2011)
Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. [ Time Frame: 5 weeks ]
Simple reaction time to an auditory signal is a measure of attention.
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Use of Modafinil in the Treatment of Tinnitus
Official Title  ICMJE Use of Modafinil in the Treatment of Tinnitus
Brief 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.
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 (e.g., the amplitude of auditory evoked responses and simple reaction time).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus
Intervention  ICMJE
  • Drug: Modafinil
    200 mg/day, morning dose
  • Other: Placebo
    Sugar pill once per day in the morning.
Study Arms  ICMJE
  • Active Comparator: modafinil
    Intervention: Drug: Modafinil
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 15, 2011)
7
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2008)
10
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00591019
Other Study ID Numbers  ICMJE # 65171
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Arkansas
Study Sponsor  ICMJE University of Arkansas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John L Dornhoffer, MD University of Arkansas
PRS Account University of Arkansas
Verification Date September 2015

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