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Clinical Trial of Acamprosate for Tinnitus

NCT00596531 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2016-11-08

No results posted yet for this study

Summary

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.

Conditions

  • Tinnitus

Interventions

DRUG

Acamprosate

Oral administration, 666 mg, tid, for 4 months

DRUG

Placebo

Oral administration of 2 pills, tid, for 4 months

Sponsors & Collaborators

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • William H Martin, Ph.D. · Oregon Health and Science University

  • Yongbing Shi, M.D., Ph.D. · Oregon Health and Science University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2013-11-30
Completion
2013-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00596531 on ClinicalTrials.gov