The Effect of Gabapentin on the Sensation and Impact of Tinnitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00257270|
Recruitment Status : Completed
First Posted : November 22, 2005
Last Update Posted : November 22, 2005
|Condition or disease||Intervention/treatment||Phase|
|Tinnitus||Drug: gabapentin||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Official Title:||The Effect of Gabapentin on the Sensation and Impact of Tinnitus|
|Study Start Date :||August 2003|
|Estimated Study Completion Date :||January 2005|
- 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.
- Quality of Life survey (SF36-QOL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00257270
|Principal Investigator:||Carol Bauer, MD||Southern Illinois University School of Medicine|