search
Back to results

Gabapentin for the Treatment of Tinnitus

Primary Purpose

Tinnitus

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Gabapentin (Neurontin)
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tinnitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults, between the ages of 18 and 70 Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory. Exclusion Criteria: The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled. Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = [(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)] X 0.85,whereCcr indicates creatinine clearance. Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone Patients with any serious or unstable medical or psychiatric condition. Patients whose ability to give informed consent is in question.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Tinnitus Handicap Inventory Score from Baseline to Week 8

    Secondary Outcome Measures

    Beck Depression Inventory Score from Baseline to Week 8
    Brief Symptom Inventory Score from Baseline to Week 8
    Epworth Sleepiness Scale Score from Baseline to Week 8

    Full Information

    First Posted
    April 21, 2006
    Last Updated
    February 29, 2012
    Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00317850
    Brief Title
    Gabapentin for the Treatment of Tinnitus
    Official Title
    Gabapentin for the Relief of Idiopathic Subjective Tinnitus
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2012
    Overall Recruitment Status
    Terminated
    Study Start Date
    April 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    February 2006 (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Washington University School of Medicine
    Collaborators
    National Institute on Deafness and Other Communication Disorders (NIDCD)

    4. Oversight

    5. Study Description

    Brief Summary
    The specific aim of the Gabapentin for the Relief of Idiopathic Subjective Tinnitus Trial is to assess the therapeutic benefit of Gabapentin (Neurontin®) for subjective idiopathic troublesome tinnitus. We employed a double-blind placebo-controlled randomized clinical trial design to assess the efficacy of Gabapentin. Adults, between the ages of 18 and 70 with idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or greater and score of 38 or greater on the Tinnitus Handicap Inventory were enrolled.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tinnitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    160 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Gabapentin (Neurontin)
    Primary Outcome Measure Information:
    Title
    Tinnitus Handicap Inventory Score from Baseline to Week 8
    Secondary Outcome Measure Information:
    Title
    Beck Depression Inventory Score from Baseline to Week 8
    Title
    Brief Symptom Inventory Score from Baseline to Week 8
    Title
    Epworth Sleepiness Scale Score from Baseline to Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Adults, between the ages of 18 and 70 Idiopathic, subjective, troublesome, unilateral or bilateral, non-pulsatile tinnitus (ICD-9 --388.31) of 6 month's duration or greater Tinnitus handicap score of 38 or greater on the Tinnitus Handicap Inventory. Exclusion Criteria: The symptoms of tinnitus can be affected by the concomitant use of tricyclic antidepressants, carbamazepine, phenytoin, valproate sodium, or benzodiazepines. Patients who have used these drugs within 30 days of screening will not be enrolled. Impaired renal function as determined from serum creatinine levels, using the following formulas35: adult male Ccr = (140 -age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter); and adult female Ccr = [(140 - age) X weight in kilograms/(72 X serum creatinine in milligrams per deciliter)] X 0.85,whereCcr indicates creatinine clearance. Patients with tinnitus related to cochlear implantation, retrocochlear lesion, or other known anatomic/structural lesions of the ear and temporal bone Patients with any serious or unstable medical or psychiatric condition. Patients whose ability to give informed consent is in question.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jay F Piccirillo, MD
    Organizational Affiliation
    Washington University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17438255
    Citation
    Piccirillo JF, Finnell J, Vlahiotis A, Chole RA, Spitznagel E Jr. Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7. doi: 10.1001/archotol.133.4.390.
    Results Reference
    derived

    Learn more about this trial

    Gabapentin for the Treatment of Tinnitus

    We'll reach out to this number within 24 hrs