Neramexane for Tinnitus

March 10, 2011 updated by: Merz Pharmaceuticals GmbH

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • main exclusion criterion: intermittent or pulsatile tinnitus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Oral tablets, duration: 16 weeks
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merz Pharmaceuticals GmbH

Investigators

  • Study Chair: Markus Suckfüll, MD PhD Ass. Prof., Ludwig-Maximilians - University of Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

November 29, 2006

First Submitted That Met QC Criteria

November 29, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Estimate)

March 11, 2011

Last Update Submitted That Met QC Criteria

March 10, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRZ 92579-0508/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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