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Neramexane for Tinnitus

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
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Tinnitus Drug: Neramexane Drug: Placebo Phase 2

Study Design

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
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

Primary Outcome Measures :
  1. Change from baseline in tinnitus severity at the endpoint visit [ Time Frame: Week 16 ]
  2. Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms [ Time Frame: From baseline until week 20 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus

Exclusion Criteria:

  • main exclusion criterion: intermittent or pulsatile tinnitus
Contacts and Locations

Information from the National Library of Medicine

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


Locations
Austria
Vienna, Austria
Germany
Munich, Germany
Sponsors and Collaborators
Merz Pharmaceuticals GmbH
Investigators
Study Chair: Markus Suckfüll, MD PhD Ass. Prof. Ludwig-Maximilians - University of Munich
More Information

Publications:
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     History of Changes
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

Additional relevant MeSH terms:
Tinnitus
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms