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The Effect of Gabapentin on the Sensation and Impact of Tinnitus

This study has been completed.
Sponsor:
Information provided by:
Tinnitus Research Consortium
ClinicalTrials.gov Identifier:
NCT00257270
First received: November 18, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted

November 18, 2005
November 18, 2005
August 2003
 
  • 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.
Same as current
No Changes Posted
Quality of Life survey (SF36-QOL)
Same as current
 
 
 
The Effect of Gabapentin on the Sensation and Impact of Tinnitus
The Effect of Gabapentin on the Sensation and Impact of Tinnitus

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.`

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.
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Treatment
Tinnitus
Drug: gabapentin
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
January 2005
 

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00257270
03-073
 
 
Tinnitus Research Consortium
 
Principal Investigator: Carol Bauer, MD Southern Illinois University School of Medicine
Tinnitus Research Consortium
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP