An Observational Study on the Clinical Efficacy of Neramexane in Subjective Tinnitus in a Phase 2 Clinical Trial in a Hispanic Cohort in Laredo, Texas

Abstract:

An observational study was conducted on the efficacy of Neramexane in a small cohort of Hispanic subjects who were diagnosed with moderate to severe subjective tinnitus. Patients were screened using the inclusion and exclusion criteria as outlined by the study sponsor. The study protocol involved daily intake of Neramexane 50 mg/day (for weigh< 90 kg) or 75 mg/day (weight> 90 kg) for 29 weeks with primary efficacy assessed through audiogram study and 3 electronic self-reporting questionnaires: Tinnitus Handicap Inventory-12 (TBF/THI-12) Scale, Tinnitus Rating Scale (TRS) and Hospital Anxiety and Depression Scale (HADS). Audiogram studies were conducted at baseline and at subsequent visits to document hearing level and progress with treatment. Comparative analysis with the subjective outcome measures (3 self-reporting questionnaires) in the cohort group of 14 patients indicate 75% improved in their subjective tinnitus after 29 weeks of Neramexane intake. The same patients that reported improved subjective tinnitus also demonstrated improved hearing. There was correlation of improved audiogram results with improved scores on the THI-12, TRS and HADS. These findings suggest potential efficacy of Neramexane in the improvement of hearing in those with moderate to severe subjective tinnitus. Associated comorbid conditions for tinnitus include hypertension, hyperthyroidism and vertigo. Pbkp_redisposing occupational risk factors and exposure to chronic ear trauma support current knowledge about tinnitus.

Año de publicación:

2017

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