Atlanta — In a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus, the drug shows promising results with a dose of 50 mg/d and 75 mg/d.
Neramexane is a new substance that exhibits antagonistic properties at both the 9/10 nicotinergic and the N methyl-D aspartate receptor, suggesting potential efficacy in the treatment of tinnitus.
The study involved a total of 431 outpatients with moderate to severe subjective tinnitus (onset 3-18 months before screening). Subjects were assigned randomly to receive either placebo or neramexane mesylate (25 mg/day, 50 mg/day and 75 mg/day) for 16 weeks, with assessment at 4-week intervals.
Compared with placebo, the largest improvement was achieved in the 50 mg/d neramexane group, followed by the 75 mg/d neramexane group.
This treatment difference did not reach statistical significance at the pre-defined endpoint in Week 16 (p = 0.098 for 50 mg/d; p = 0.289 for 75 mg/d neramexane), but consistent numerical superiority of both neramexane groups compared with placebo was observed.
Four weeks after the end of treatment, assessment scores in the 50 mg/d group were significantly better than those of the controls.
Laboratory values, electrocardiography, and vital signs revealed no relevant influence of the study medication. Dizziness was the most common adverse event and showed a clear dose-dependence.
The researchers concluded that this dose-finding study demonstrated the safety and tolerability of neramexane treatment in patients with moderate to severe tinnitus and allowed appropriate dose selection for conducting further studies.
The abstract and full text of “A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus” is currently available online.
SOURCE: BMC Ear, Nose and Throat Disorders