Clinical Trial of Acamprosate for Tinnitus - Full Text View

Sponsor:	Oregon Health and Science University
Information provided by:	Oregon Health and Science University
ClinicalTrials.gov Identifier:	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.

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. Participation in the study requires that individuals come to Portland, Oregon at least 6 times over 16 months for evaluation and data collection.

Condition	Intervention	Phase
Tinnitus	Drug: Acamprosate Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Clinical Trial of Acamprosate for Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus

Drug Information available for: Acamprosate calcium Acamprosate

U.S. FDA Resources

Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:

Tinnitus Handicap Index Tinnitus Functional Index Tinnitus loudness score on visual numerical scale [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Depression Inventory Psychoacoustic measures of tinnitus [ Time Frame: 15 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
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
Experimental: A Subjects taking acamprosate	Drug: Acamprosate Oral administration, 666 mg, tid, for 4 months Other Name: Campral
Placebo Comparator: B Subjects taking placeboes	Drug: Placebo Oral administration of 2 pills, tid, for 4 months

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Functional Index scores. Rated loudness: >6 on a 0-10 visual numerical scale. 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00596531

Locations

United States, Oregon
OHSU
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University

Investigators

Principal Investigator:	William H Martin, Ph.D.	Oregon Health and Science University
Principal Investigator:	Yongbing Shi, M.D., Ph.D.	Oregon Health and Science University

More Information

Additional Information:

website for host of study This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Martin, William Hal/Director, OHSU Tinnitus Clinic
ClinicalTrials.gov Identifier:	NCT00596531 History of Changes
Other Study ID Numbers:	00003412, IRB00003412
Study First Received:	January 8, 2008
Last Updated:	February 12, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Health and Science University:

Tinnitus
acamprosate
clinical trial

Additional relevant MeSH terms:

Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases

Signs and Symptoms
Acamprosate
Alcohol Deterrents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012