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Neramexane for Tinnitus
This study has been completed.
First Received: November 29, 2006   Last Updated: January 28, 2008   History of Changes
Sponsored by: Merz Pharmaceuticals GmbH
Information provided by: Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier: NCT00405886
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Change from baseline in tinnitus severity at the endpoint visit

Estimated Enrollment: 400
Study Start Date: October 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Hearing Disorders
Otorhinolaryngologic Diseases
Neurologic Manifestations
Ear Diseases
Tinnitus

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

ClinicalTrials.gov processed this record on September 03, 2009