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Neramexane for Tinnitus

This study has been completed.
Sponsor:
Information provided by:
Merz Pharmaceuticals GmbH
ClinicalTrials.gov Identifier:
NCT00405886
First received: November 29, 2006
Last updated: March 10, 2011
Last verified: March 2011
History of Changes
  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
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Tinnitus
U.S. FDA Resources

Further study details as provided by Merz Pharmaceuticals GmbH:

Primary Outcome Measures:
  • Change from baseline in tinnitus severity at the endpoint visit [ Time Frame: Week 16 ] [ Designated as safety issue: No ]
  • Comparison of adverse events (type, severity, seriousness, frequency, relatedness) between treatment arms [ Time Frame: From baseline until week 20 ] [ Designated as safety issue: Yes ]

Enrollment: 431
Study Start Date: October 2005
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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

Publications:
Suckfüll et al.: A randomized, double-blind, placebocontrolled clinical trial to evaluate the efficacy and safety of neramexane in patients with moderate to severe subjective tinnitus. BMC Ear, Nose and Throat Disorders 2011 11:1. http://www.biomedcentral.com/1472-6815/11/1

Additional 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
Study First Received: November 29, 2006
Last Updated: March 10, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on May 16, 2013