Get Tinnitus Relief

CLINICAL TRIAL OF ACAMPROSATE FOR TINNITUS RELIEF

I wanted to take a moment and make you aware of a clinical trial for tinnitus. I’m sure there are some of you that may want to participate in it. It is through carefully controlled research that medical science progresses. This clinical trial is for the drug acamprosate. Previous studies have indicated that acamprosate was able to provide tinnitus relief above and beyond the placebo control. The current study aims to replicate that result.

CONTACT

The trial is being conducted by the Oregon Health and Sciences University in Portland Oregon. The ClinicalTrials.gov identifier is NCT00596531. The contact information is:

William H Martin, Ph.D.

(503) 494-7954

martinw@ohsu.edu

http://clinicaltrials.gov/ct2/show/NCT00596531

PURPOSE

The objective of this project is to determine whether acamprosate is more effective at providing relief for tinnitus than a placebo.

Acamprosate has been suggested to be effective in reducing tinnitus annoyance in a preliminary study. Study evidence indicates that tinnitus is related to increased excitatory spontaneous brain activities. Acamprosate may help restore the excitatory/inhibitory balance in the brain and thus reduce tinnitus

STUDY DESIGN

The current study includes three phases. The first phase is an open-label screening study used to identify tinnitus subjects responding to acamprosate. These responding subjects will enter the second phase, which is a double blind, placebo-controlled study aimed at confirming the subjects’ responses to acamprosate. In the third phase, clinical parameters of both responders and non-responders will be compared using a multi-linear regression model to determine characteristics that define the sub-group of tinnitus patients that are likely to benefit from acamprosate treatment.

Estimated Enrollment:     186
Study Start Date:     January 2008
Estimated Study Completion Date:     December 2010
Estimated Primary Completion Date:     December 2010 (Final data collection date for primary outcome measure)
Arms     Assigned Interventions
A: Experimental
Subjects taking acamprosate
Drug: Acamprosate
Oral administration, 666 mg, tid, for 6 months
B: Placebo Comparator
Subjects taking placeboes
Drug: Placebo
Oral administration of 2 pills, tid, for 6 months

STUDY OUTCOME MEASURES

Tinnitus Handicap Index Tinnitus loudness score on visual analogue scale Tinnitus annoyance score on visual analogue scale.
ELIGIBILITY

Ages Eligible for Study:       18 Years to 85 Years
Genders Eligible for Study:       Both
Accepts Healthy Volunteers:       No

INCLUSION CRUTERIA

* Concurrent treatments: Amplification, sound generators or cochlear implants are permitted, provided they have been in use for at least one year. A four-week washout from any other tinnitus treatment or management program is required prior to entering this study.
* Hearing function: All levels of hearing function can be included recognizing that profound, bilateral losses will not be able to perform psychophysical tinnitus and hearing tests but will be able to rate subjective loudness, annoyance and impact on life.
* Tinnitus etiology: All forms of tinnitus etiology will be accepted into Phase I providing they meet the following tinnitus criterion. Duration: 1 year or longer. Stability: Constant. Severity: > 50th percentile of OHSU Tinnitus Patients based upon Tinnitus Severity Index (TSI) scores. Rated loudness: > 7 cm from the left on a visual analog scale (VAS) 10 cm in length. Rated annoyance: > 7 cm from the left on a visual analog scale (VAS) 10 cm in length. Tinnitus location: Unrestricted.

EXCLUSION CRITERIA

* Medical conditions: Active neurologic or otologic disease processes that may impact tinnitus perception. Auto-immune diseases. Pregnancy or planned pregnancy during the study.
* Renal function: Subjects with documented renal disorders will be excluded if renal function has creatinine clearance is <50 mL/minute.
* Digestive tract problems: Subjects with digestive tract disorders will be excluded.
* Psychological status: Beck Depression Inventory score of greater than 15.
* Tinnitus duration: Less than 1 year. Stability: pulsatile, intermittent, varying to a high degree in loudness or changing in location of perception. Severity: < 50th percentile of OHSU Tinnitus Patients based upon Tinnitus Severity Index (TSI) scores. Rated loudness: < 7 cm from the left on a visual analog scale (VAS) 10 cm in length. Rated annoyance: < 7 cm from the left on a visual analog scale (VAS) 10 cm in length.

Home | About Us | Contact Us | Privacy Policy | Site Map

This entry was posted on Tuesday, January 19th, 2010 at 12:04 pm and is filed under Tinnitus. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.