Gabapentin for the Treatment of Tinnitus

Phase 2

Terminated

• Conditions: Tinnitus

• Registration Number: NCT00317850
• Lead Sponsor: Washington University School of Medicine

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 wit...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-04
• Study Completion: 2006-02
• Study First Submitted: 2006-04-21
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-25
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-29
• Last Update Posted: 2012-03-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 160

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tinnitus Handicap Inventory Score from Baseline to Week 8

Secondary Outcome Measures

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