Clinical Trial of Acamprosate for Tinnitus

NCT00596531 | Completed Phase 1 DMC

• 2 other identifiers: 00003412IRB00003412
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tinnitus; acamprosate; clinical trial

Outcome Measures

Primary Outcomes (1)

• Tinnitus Handicap Index Tinnitus Functional Index Tinnitus loudness score on visual numerical scale

  15 months

Secondary Outcomes (1)

• Depression Inventory Psychoacoustic measures of tinnitus

  15 months

Study Arms (2)

A

ACTIVE COMPARATOR

Subjects will take acamprosate (Campral) at a dose of 666 mg. three times daily (morning, lunch time, bed time) for 28 days. Only responders will be included in the subsequent double-blind cross over arms after a minimum washout period of 4 weeks. Subjects will randomly be assigned to Group 1 (A/B) or Group 2 (B/A) after completion of Phase I and its subsequent washout period (Figure 1, periods 1 and 2). Group 1 will receive acamprosate (Campral) at a dose of 666 mg. three times daily for 24 weeks followed by a 4-week washout period

Drug: Acamprosate

B

PLACEBO COMPARATOR

Group 2 will be assigned to the placebo group and take matched placebos for next 24 weeks followed by a 4-week washout period. After the washout period each group will be assigned to the other intervention (acamprosate or placebo) and complete another trial for 24 weeks.

Drug: Placebo

Interventions

Acamprosate DRUG

Oral administration, 666 mg, tid, for 4 months

Also known as: Campral

A

Placebo DRUG

Oral administration of 2 pills, tid, for 4 months

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

OHSU

Portland, Oregon, 97239, United States

Location

Related Links

• website for host of study

MeSH Terms

Conditions

Tinnitus

Interventions

Acamprosate

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)

Taurine; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• William H Martin, Ph.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

• Yongbing Shi, M.D., Ph.D.

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2008
• First Posted: January 17, 2008
• Study Start: January 1, 2008
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: November 8, 2016

Record last verified: 2016-11

Locations

US (1)