ClinicalTrials.gov
ClinicalTrials.gov Menu

Gabapentin for the Treatment of Tinnitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00317850
Recruitment Status : Terminated
First Posted : April 25, 2006
Last Update Posted : March 2, 2012
Sponsor:
Collaborator:
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine

April 21, 2006
April 25, 2006
March 2, 2012
April 2004
Not Provided
Tinnitus Handicap Inventory Score from Baseline to Week 8
Same as current
Complete list of historical versions of study NCT00317850 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Gabapentin for the Treatment of Tinnitus
Gabapentin for the Relief of Idiopathic Subjective Tinnitus
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Tinnitus
Drug: Gabapentin (Neurontin)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
160
Same as current
February 2006
Not Provided

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00317850
R01DC006253-01( U.S. NIH Grant/Contract )
R01DC006253 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Jay F. Piccirillo, MD, Washington University School of Medicine
Washington University School of Medicine
National Institute on Deafness and Other Communication Disorders (NIDCD)
Principal Investigator: Jay F Piccirillo, MD Washington University School of Medicine
Washington University School of Medicine
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP