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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

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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Modafinil Other: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of Modafinil in the Treatment of Tinnitus
Study Start Date : August 2006
Actual Primary Completion Date : March 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus

Arm Intervention/treatment
Active Comparator: modafinil Drug: Modafinil
200 mg/day, morning dose

Placebo Comparator: Placebo Other: Placebo
Sugar pill once per day in the morning.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00591019


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: John L Dornhoffer, MD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT00591019     History of Changes
Other Study ID Numbers: # 65171
First Posted: January 11, 2008    Key Record Dates
Results First Posted: May 9, 2011
Last Update Posted: October 8, 2015
Last Verified: September 2015
Keywords provided by University of Arkansas:
P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time
Additional relevant MeSH terms:
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Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Wakefulness-Promoting Agents
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action