Neramexane for Tinnitus
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00405886 |
Recruitment Status :
Completed
First Posted : November 30, 2006
Last Update Posted : March 11, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tinnitus | Drug: Neramexane Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 431 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | October 2005 |
Actual Primary Completion Date : | March 2007 |
Actual Study Completion Date : | March 2007 |
Arm | Intervention/treatment |
---|---|
Experimental: Neramexane 25mg/d |
Drug: Neramexane
Oral tablets, duration: 16 weeks |
Experimental: Neramexane 50mg/d |
Drug: Neramexane
Oral tablets, duration: 16 weeks |
Experimental: Neramexane 75mg/d |
Drug: Neramexane
Oral tablets, duration: 16 weeks |
Placebo Comparator: Placebo |
Drug: Placebo
Oral tablets, duration: 16 weeks |
- Change from baseline in tinnitus severity at the endpoint visit [ Time Frame: Week 16 ]
- Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms [ Time Frame: From baseline until week 20 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus
Exclusion Criteria:
- main exclusion criterion: intermittent or pulsatile tinnitus

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405886
Austria | |
Vienna, Austria | |
Germany | |
Munich, Germany |
Study Chair: | Markus Suckfüll, MD PhD Ass. Prof. | Ludwig-Maximilians - University of Munich |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Dr. Matthias Zerm, Manager Public Disclosure, Merz Pharmaceuticals GmbH |
ClinicalTrials.gov Identifier: | NCT00405886 |
Other Study ID Numbers: |
MRZ 92579-0508/1 |
First Posted: | November 30, 2006 Key Record Dates |
Last Update Posted: | March 11, 2011 |
Last Verified: | March 2011 |
Tinnitus Hearing Disorders Ear Diseases Otorhinolaryngologic Diseases |
Sensation Disorders Neurologic Manifestations Nervous System Diseases |