The Effect of Gabapentin on the Sensation and Impact of Tinnitus

Tinnitus Clinical Trial

Official title:

The Effect of Gabapentin on the Sensation and Impact of Tinnitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00257270
• Other study ID #: 03-073
• Status: Completed
• Phase: Phase 2
• First received: November 18, 2005
• Last updated: November 18, 2005
• Start date: August 2003
• Est. completion date: January 2005

Study information

• Verified date: June 2005
• Source: Tinnitus Research Consortium
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study evaluated the effectiveness of gabapentin in treating tinnitus in two populations: Tinnitus with associated acoustic trauma and tinnitus without associated acoustic trauma. The hypothesis was that gabapentin would decrease both subjective and objective features of tinnitus in the trauma group, but would be less effective in the non-trauma group.`

Description:

Methods. A prospective, placebo-controlled, single-blind study of the effect of gabapentin on tinnitus was employed. Audiograms and personal histories were used to categorize tinnitus etiology as either secondary to acoustic trauma, or not associated with acoustic trauma. Participants were restricted to those with moderate-to-severe tinnitus for at least one year. All participants received gabapentin in a graduated ascending-descending dose series over 20 weeks (peak dose of 2400 mg/day).

Results. There was a significant improvement in tinnitus annoyance for the trauma group (p = 0.05). Other subjective aspects of tinnitus were not significantly affected in either group. Between-subject variability of therapeutic response was considerable. Nevertheless, considering subjective loudness ratings, 4/19 non-trauma participants, and 6/20 trauma participants showed an improvement of 20 percent or better. Considering psychoacoustic loudness estimates, 4/19 non-trauma and 6/20 trauma participants showed a 15 dB (HL) improvement. Evenly dividing each group into high and low responders revealed significant improvement in loudness at 1800 and 2400 mg/day for the trauma high-response subgroup (p = 0.007). No significant improvement was obtained for other subgroups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• non-pulsatile tinnitus present > 1 year

• Tinnitus Handicap Questionnaire score > 30

• ability to perform psychophysical matching procedure

Exclusion Criteria:

• evidence of depression

• renal insufficiency

• conductive hearing loss

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tinnitus

Intervention

Drug:
• gabapentin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tinnitus Research Consortium

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psychophysical loudness match of tinnitus to broad band noise and pure tones.
Primary	Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
Primary	The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.
Secondary	Quality of Life survey (SF36-QOL)