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Sponsored by: |
Merz Pharmaceuticals GmbH |
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Information provided by: | Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00405886 |
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.
Condition | Intervention | Phase |
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Tinnitus |
Drug: Neramexane |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Randomised, Double-Blind, Placebo-Controlled, Clinical Dose-Ranging Trial to Evaluate Efficacy and Safety of a NMDA Antagonist for Oral Administration in Patients With Subjective Tinnitus |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | MRZ 92579-0508/1 |
Study First Received: | November 29, 2006 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00405886 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Neurologic Manifestations Ear Diseases Tinnitus |
Signs and Symptoms Sensation Disorders Hearing Disorders Otorhinolaryngologic Diseases |
Nervous System Diseases Neurologic Manifestations Ear Diseases Tinnitus |