Effect of Gabapentin on Idiopathic Subjective Tinnitus

Subjective Tinnitus Clinical Trial

Official title:

Phase 2 Effect of Gabapentin on Idiopathic Subjective Tinnitus

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00555776
• Other study ID #: Gaba-tinntus-145
• Status: Unknown status
• Phase: Phase 2
• First received: November 8, 2007
• Last updated: January 5, 2009
• Start date: January 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2008
• Source: Islamic Azad University of Mashhad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 70
• Est. completion date: October 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Subjective Tinnitus
• Tinnitus

Intervention

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.
• placebo
placebo is given with the same definition as Gabapentin

Locations

Country	Name	City	State
Iran, Islamic Republic of	ENT department of Mashhad Azad medical university	Mashhad	Khorasan razavi

Sponsors (1)

Lead Sponsor	Collaborator
Islamic Azad University of Mashhad

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

Bakhshaee M, Ghasemi M, Azarpazhooh M, Khadivi E, Rezaei S, Shakeri M, Tale M. Gabapentin effectiveness on the sensation of subjective idiopathic tinnitus: a pilot study. Eur Arch Otorhinolaryngol. 2008 May;265(5):525-30. Epub 2007 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		two months
Secondary	Relieve of complications of tinnitus, such as sleep difficulties.		two months