Status:
TERMINATED
Gabapentin for the Treatment of Tinnitus
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Conditions:
Tinnitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00317850
Start Date
April 1 2004
End Date
February 1 2006
Last Update
March 2 2012
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