Tinnitus
Conditions
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.
Interventions
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Tinnitus Handicap Inventory Score from Baseline to Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Outcome results
None listed