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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neramexane 25mg/d | Experimental |
| |
| Neramexane 50mg/d | Experimental |
| |
| Neramexane 75mg/d | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Neramexane | Drug | Oral tablets, duration: 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in tinnitus severity at the endpoint visit | Week 16 | |
| Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms | From baseline until week 20 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Markus Suckfüll, MD PhD Ass. Prof. | Ludwig-Maximilians - University of Munich | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna | Austria | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21223542 | Result | Suckfull M, Althaus M, Ellers-Lenz B, Gebauer A, Gortelmeyer R, Jastreboff PJ, Moebius HJ, Rosenberg T, Russ H, Wirth Y, Krueger H. A randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus. BMC Ear Nose Throat Disord. 2011 Jan 11;11:1. doi: 10.1186/1472-6815-11-1. | |
| 21751942 |
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| ID | Term |
|---|---|
| D014012 | Tinnitus |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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| ID | Term |
|---|---|
| C114144 | neramexane |
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| Placebo | Drug | Oral tablets, duration: 16 weeks |
|
| Munich |
| Germany |
| Derived |
| Gortelmeyer R, Schmidt J, Suckfull M, Jastreboff P, Gebauer A, Kruger H, Wittmann W. Assessment of tinnitus-related impairments and disabilities using the German THI-12: sensitivity and stability of the scale over time. Int J Audiol. 2011 Aug;50(8):523-9. doi: 10.3109/14992027.2011.578591. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |