Gabapentin for the Treatment of Tinnitus

Condition(s) targeted: Tinnitus

Intervention: Gabapentin (Neurontin) (Drug)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD)

Official(s) and/or principal investigator(s):
Jay F Piccirillo, MD, Principal Investigator, Affiliation: Washington University School of Medicine

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.

Official title: Gabapentin for the Relief of Idiopathic Subjective Tinnitus

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Tinnitus Handicap Inventory Score from Baseline to Week 8

Secondary outcome:

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Clinical Outcomes Research Office at the Washington University School of Medicine

Starting date: April 2004
Ending date: February 2006
Last updated: May 12, 2006