Gabapentin for the Treatment of Tinnitus
This study has been terminated.
Sponsor:
Washington University School of Medicine
Collaborator:
Information provided by (Responsible Party):
Jay F. Piccirillo, MD, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT00317850
First received: April 21, 2006
Last updated: February 29, 2012
Last verified: February 2012
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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 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Gabapentin for the Relief of Idiopathic Subjective Tinnitus |
Resource links provided by NLM:
Further study details as provided by Washington University School of Medicine:
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 More Information
Additional Information:
No publications provided by Washington University School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jay F. Piccirillo, MD, Professor of Otolaryngology, Director of Clinical Outcomes Research Office, Washington University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00317850 History of Changes |
| Other Study ID Numbers: | R01 DC006253-01, R01DC006253 |
| Study First Received: | April 21, 2006 |
| Last Updated: | February 29, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases Signs and Symptoms Gabapentin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Anticonvulsants Antiparkinson Agents Anti-Dyskinesia Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on June 17, 2013