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 vigilance.

Study Overview

• Status: Terminated
• Conditions: Tinnitus
• Intervention / Treatment: Drug: Modafinil; Other: Placebo

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: Interventional
• Enrollment (Actual): 7
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • University of Arkansas for Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Sugar pill once per day in the morning.
Active Comparator: modafinil	Drug: Modafinil; 200 mg/day, morning dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).	P50 is an auditory evoked response potential sensitive to states of arousal.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.	Simple reaction time to an auditory signal is a measure of attention.	5 weeks

Collaborators and Investigators

• Sponsor: University of Arkansas
• Investigators: Principal Investigator: John L Dornhoffer, MD, University of Arkansas

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): March 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: December 27, 2007
• First Submitted That Met QC Criteria: January 10, 2008
• First Posted (Estimate): January 11, 2008

Study Record Updates

• Last Update Posted (Estimate): October 8, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Tinnitus; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: # 65171