Gabapentin for the Treatment of Tinnitus

This study has been terminated.

First Received: April 21, 2006 Last Updated: May 12, 2006 History of Changes

Sponsor:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00317850

Purpose

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.

Condition	Intervention	Phase
Tinnitus	Drug: Gabapentin (Neurontin)	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Gabapentin for the Relief of Idiopathic Subjective Tinnitus

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus Toe Injuries and Disorders

Drug Information available for: Gabapentin

U.S. FDA Resources

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Primary Outcome Measures:

Tinnitus Handicap Inventory Score from Baseline to Week 8

Secondary Outcome Measures:

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

Estimated Enrollment:	160
Study Start Date:	April 2004
Estimated Study Completion Date:	February 2006

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00317850

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Principal Investigator:

Jay F Piccirillo, MD

Washington University School of Medicine

More Information

Additional Information:

Clinical Outcomes Research Office at the Washington University School of Medicine This link exits the ClinicalTrials.gov site

No publications provided by National Institute on Deafness and Other Communication Disorders (NIDCD)

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	R01 DC006253-01
Study First Received:	April 21, 2006
Last Updated:	May 12, 2006
ClinicalTrials.gov Identifier:	NCT00317850 History of Changes
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Sensation Disorders
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Ear Diseases
Tinnitus
Membrane Transport Modulators
Signs and Symptoms
Hearing Disorders

Sensory System Agents
Therapeutic Uses
Analgesics
Excitatory Amino Acid Antagonists
Otorhinolaryngologic Diseases
Tranquilizing Agents
Nervous System Diseases
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Neurologic Manifestations
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 22, 2009