Gabapentin for the Treatment of Tinnitus

Phase 3TerminatedNCT00317850

Washington University School of Medicine160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

160

Conditions

Tinnitus

Interventions

Gabapentin (Neurontin)DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Tinnitus Handicap Inventory Score from Baseline to Week 8

Secondary Outcomes

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

Data from ClinicalTrials.gov

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