Official Title: “Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus”

The purpose of this study is to determine wether Gabapentin which is useful for treating neuropathic pains, is effective on idiopathic subjective tinnitus.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2008

Tinnitus is the perception of sound in the absence of acoustic stimulation. It can be subjective or objective. .

Despite numerous researches,no effective treatment for people who suffer from tinnitus has yet been stablished.

As there are many evidences suggesting that loss of inhibition in the central nervous system may be responsible for many aspects of auditory dysfunction,including tinnitus; and as Gabapentin (Neurontin), a gama-aminobutyric acid (GABA) analogue, is an effective medication in conditions where inhibition in the CNS is impaired; we guess that Gabapentin might be useful for treating idiopathic subjective tinnitus.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • Gabapentin, 600 mg bid for the first two weeks, increased to a maximum dose of 1800 mg per day during the next 6 weeks if necessary.
• Drug: placebo
  • placebo is given with the same definition as Gabapentin

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Randomly,half of the subjects are given Gabapentin.
• Placebo Comparator: 2
  • Randomly,half of the subjects receive placebo.

Primary Measures

• Reduction in the sensation of Tinnitus by the patient or complete resolution of tinnitus;by the patient's scoring it from one to ten, before and after prescribing Gabapentin.
  • Time Frame: two months
    Safety Issue?: Yes

Secondary Measures

• Relieve of complications of tinnitus, such as sleep difficulties.
  • Time Frame: two months
    Safety Issue?: Yes

Inclusion Criteria:

• patients with subjective idiopathic tinnitus

Exclusion Criteria:

• tinnitus with known underlying cause
• pregnant women and patients younger than 18 or older than 75 years
• patients with impaired renal function

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Islamic Azad University of Mashhad

Overall Clinical Trial Officials and Contacts

Mahboobeh Adami Dehkordi, MD Principal Investigator ENT department of Mashhad azad university of mashhad  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00555776

Study ID Number: Gaba-tinntus-145

ClinicalTrials.gov Identifier: NCT00555776

Health Authority: Iran: Ministry of Health