Gabapentin for the Treatment of Tinnitus

NCT ID: NCT00317850

Last Updated: 2012-03-02

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2006-02-28

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.

Conditions

Tinnitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Gabapentin (Neurontin)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jay F. Piccirillo, MD

Professor of Otolaryngology, Director of Clinical Outcomes Research Office

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jay F Piccirillo, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

References

Piccirillo JF, Finnell J, Vlahiotis A, Chole RA, Spitznagel E Jr. Relief of idiopathic subjective tinnitus: is gabapentin effective? Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7. doi: 10.1001/archotol.133.4.390.

Reference Type: DERIVED

PMID: 17438255 (View on PubMed)

Other Identifiers

R01DC006253

Identifier Type: NIH

Identifier Source: secondary_id

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R01DC006253-01

Identifier Type: NIH

Identifier Source: org_study_id

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