Neramexane for Tinnitus
- Registration Number
- NCT00405886
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
Tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the absence of an external source of acoustic signals. Tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. One hypothesis is that tinnitus is caused by an increased activity of NMDA glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. Neramexane may alleviate tinnitus symptoms due to its NMDA and alpha9/alpha10 nACh receptor blocking activity. The purpose of this study is to assess the safety and efficacy of Neramexane compared with placebo in patients with subjective tinnitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 431
Inclusion Criteria
- main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus
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Exclusion Criteria
- main exclusion criterion: intermittent or pulsatile tinnitus
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - Neramexane 50mg/d Neramexane - Neramexane 75mg/d Neramexane - Neramexane 25mg/d Neramexane -
- Primary Outcome Measures
Name Time Method Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms From baseline until week 20 Change from baseline in tinnitus severity at the endpoint visit Week 16
- Secondary Outcome Measures
Name Time Method