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Sponsored by: |
Tinnitus Research Consortium |
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Information provided by: | Tinnitus Research Consortium |
ClinicalTrials.gov Identifier: | NCT00257270 |
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.`
Condition | Intervention | Phase |
---|---|---|
Tinnitus |
Drug: gabapentin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Single Blind, Placebo Control, Crossover Assignment, Efficacy Study |
Official Title: | The Effect of Gabapentin on the Sensation and Impact of Tinnitus |
Estimated Enrollment: | 40 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | January 2005 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 03-073 |
Study First Received: | November 18, 2005 |
Last Updated: | November 18, 2005 |
ClinicalTrials.gov Identifier: | NCT00257270 History of Changes |
Health Authority: | United States: Institutional Review Board |
Chronic Tinnitus Acoustic trauma |
Psychophysics Loudness match gabapentin |
Excitatory Amino Acids Sensation Disorders Neurotransmitter Agents Tranquilizing Agents Otorhinolaryngologic Diseases Gabapentin Psychotropic Drugs Wounds and Injuries Central Nervous System Depressants Calcium Channel Blockers Cardiovascular Agents |
Antimanic Agents Tinnitus Ear Diseases Signs and Symptoms Calcium, Dietary Hearing Disorders Neurologic Manifestations Anti-Anxiety Agents Analgesics Peripheral Nervous System Agents Anticonvulsants |
Sensation Disorders Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Gabapentin Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Calcium Channel Blockers Excitatory Amino Acid Agents Ear Diseases Tinnitus Membrane Transport Modulators Signs and Symptoms Hearing Disorders |
Sensory System Agents Therapeutic Uses Analgesics Excitatory Amino Acid Antagonists Otorhinolaryngologic Diseases Tranquilizing Agents Nervous System Diseases Central Nervous System Depressants Cardiovascular Agents Antimanic Agents Pharmacologic Actions Neurologic Manifestations Anti-Anxiety Agents Peripheral Nervous System Agents Central Nervous System Agents |