Gabapentin for the Treatment of Tinnitus

Tinnitus Clinical Trial

Official title:

Gabapentin for the Relief of Idiopathic Subjective Tinnitus

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00317850
• Other study ID #: R01DC006253-01
• Secondary ID: R01DC006253
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: April 21, 2006
• Last updated: February 29, 2012
• Start date: April 2004
• Est. completion date: February 2006

Study information

• Verified date: February 2012
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: February 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• Gabapentin (Neurontin)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute on Deafness and Other Communication Disorders (NIDCD)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tinnitus Handicap Inventory Score from Baseline to Week 8
Secondary	Beck Depression Inventory Score from Baseline to Week 8
Secondary	Brief Symptom Inventory Score from Baseline to Week 8
Secondary	Epworth Sleepiness Scale Score from Baseline to Week 8