The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Information source: Tinnitus Research Consortium
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tinnitus
Intervention: gabapentin (Drug)
Phase: Phase 2
Sponsored by: Tinnitus Research Consortium
Official(s) and/or principal investigator(s):
Carol Bauer, MD, Principal Investigator, Affiliation: Southern Illinois University School of Medicine
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.`
Official title: The Effect of Gabapentin on the Sensation and Impact of Tinnitus
Study design: Treatment, Non-Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study
Psychophysical loudness match of tinnitus to broad band noise and pure tones.
Subjective evaluation of tinnitus impact using Tinnitus Handicap Questionnaire.
The subjective and objective measures were obtained after treatment with placebo and 4 doses of gabapentin.
Secondary outcome: Quality of Life survey (SF36-QOL)
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.
Minimum age: 18 Years.
Maximum age: 75 Years.
- non-pulsatile tinnitus present > 1 year
- Tinnitus Handicap Questionnaire score > 30
- ability to perform psychophysical matching procedure
- evidence of depression
- renal insufficiency
- conductive hearing loss
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Starting date: August 2003
Ending date: January 2005
Last updated: November 18, 2005