Investigate the effect of neramexane in subjective tinnitus.
Methods
431 patients with subjective tinnitus and with an onset minimum three and maximum 18 months were included. They were randomized to receive placebo or 25 mg/d, 50 mg/d, and 75 mg/d of neramexane mesylate, a new alpha9/10 and NMDA receptor antagonist. Subjects were evaluated before treatment (screening), at baseline, after four, eight, 12, and 16 weeks of treatment, and four weeks after termination of trial medication intake.
Results
The primary efficacy analysis was based on the total score of the German short version of the Tinnitus Handicap Inventory questionnaire (THI-12 [TBF12]), a validated tool used to assess tinnitus suffering. Compared to placebo, the largest improvement was observed in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group. These treatment differences did not reach statistical significance at endpoint (p=0.098 for 50 mg/d; p=0.289 for 75 mg/d neramexane, two-factorial ANCOVA with THI-12 at baseline as covariate, ITT-LOCF) but there was a trend towards superiority compared to placebo for the 50 mg/d neramexane group.
Conclusions
Four weeks after the end of treatment, THI-12 scores of the 50 mg group were significantly better than those of the controls (p = 0.021) Secondary efficacy variables supported this trend and revealed p-values of p<0.05 for the 50 mg/d neramexane group regarding the functional-communicational subscores of the THI-12, assessment of tinnitus annoyance and tinnitus impact on life measured on a Likert-like scale. Preliminary data have been presented at the International Tinnitus Congress in Gothenborg, Sweden 2008.
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