Use of Modafinil in the Treatment of Tinnitus - Full Text View

Sponsor:	University of Arkansas
Information provided by (Responsible Party):	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00591019

Purpose

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	Intervention	Phase
Tinnitus	Drug: Modafinil Other: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Use of Modafinil in the Treatment of Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

Drug Information available for: Modafinil

U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset). [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
P50 is an auditory evoked response potential sensitive to states of arousal.

Secondary Outcome Measures:

Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms. [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
Simple reaction time to an auditory signal is a measure of attention.

Enrollment:	7
Study Start Date:	August 2006
Study Completion Date:	June 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: modafinil	Drug: Modafinil 200 mg/day, morning dose
Placebo Comparator: Placebo	Other: Placebo Sugar pill once per day in the morning.

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).

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00591019

Locations

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

Sponsors and Collaborators

University of Arkansas

Investigators

Principal Investigator:

John L Dornhoffer, MD

University of Arkansas

More Information

No publications provided

Responsible Party:	University of Arkansas
ClinicalTrials.gov Identifier:	NCT00591019 History of Changes
Other Study ID Numbers:	# 65171
Study First Received:	December 27, 2007
Results First Received:	February 28, 2011
Last Updated:	September 29, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Arkansas:

P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time

Additional relevant MeSH terms:

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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 12, 2012