Gabapentin for the Treatment of Tinnitus
Gabapentin for the Relief of Idiopathic Subjective Tinnitus
2 other identifiers
interventional
160
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2004
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
April 21, 2006
CompletedFirst Posted
Study publicly available on registry
April 25, 2006
CompletedMarch 2, 2012
February 1, 2012
April 21, 2006
February 29, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Tinnitus Handicap Inventory Score from Baseline to Week 8
Secondary Outcomes (3)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 17438255DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jay F Piccirillo, MD
Washington University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Otolaryngology, Director of Clinical Outcomes Research Office
Study Record Dates
First Submitted
April 21, 2006
First Posted
April 25, 2006
Study Start
April 1, 2004
Study Completion
February 1, 2006
Last Updated
March 2, 2012
Record last verified: 2012-02