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Use of Modafinil in the Treatment of Tinnitus

Primary Purpose

Tinnitus

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Modafinil
Placebo
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus focused on measuring P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time

Eligibility Criteria

20 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

modafinil

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 27, 2007
Last Updated
September 23, 2015
Sponsor
University of Arkansas
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1. Study Identification

Unique Protocol Identification Number
NCT00591019
Brief Title
Use of Modafinil in the Treatment of Tinnitus
Official Title
Use of Modafinil in the Treatment of Tinnitus
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to lack of change in primary and secondary outcome measures.
Study Start Date
August 2006 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Arkansas

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tinnitus
Keywords
P50, Psychomotor Vigilance Test (PVT), Arousal, Reaction Time

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
Participant
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
modafinil
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Modafinil
Intervention Description
200 mg/day, morning dose
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Sugar pill once per day in the morning.
Primary Outcome Measure Information:
Title
The P50 Amplitude (i.e. Evoked Auditory Response Potential Recorded in Millivolts 50 Milliseconds After Sound Onset).
Description
P50 is an auditory evoked response potential sensitive to states of arousal.
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Simple Reaction Time (Attention)for Baseline, Modafinil and Placebo Arms.
Description
Simple reaction time to an auditory signal is a measure of attention.
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John L Dornhoffer, MD
Organizational Affiliation
University of Arkansas
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Use of Modafinil in the Treatment of Tinnitus

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