Use of Modafinil in the Treatment of Tinnitus

NCT00591019 | Terminated Phase 1 Results

• 1 other identifier: # 65171
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Tinnitus

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.

  5 weeks

Study Arms (2)

modafinil

ACTIVE COMPARATOR

Drug: Modafinil

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Modafinil DRUG

200 mg/day, morning dose

modafinil

Placebo OTHER

Sugar pill once per day in the morning.

Placebo

Eligibility Criteria

• Age: 20 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Unstable angina
• New York Heart Association (NYHA) Grade II or greater congestive heart failure (see Appendix D)

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Study was terminated early due to lack of change in primary and secondary outcome measures.

Results Point of Contact

• Title: Dr John Dornhoffer
• Organization: University of Arkansas for Medical Sciences (UAMS)

dornhofferjohnl@uams.edu

501 686-5140

Study Officials

• John L Dornhoffer, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2007
• First Posted: January 11, 2008
• Study Start: August 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: June 1, 2008
• Last Updated: October 8, 2015
• Results First Posted: May 9, 2011

Record last verified: 2015-09

Locations

US (1)