Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus (EASE)

February 3, 2016 updated by: Merz Pharmaceuticals GmbH

A Randomized, Double-Blind, Placebo-Controlled, Clinical Evaluation of the Efficacy, Safety and Tolerability of Neramexane in Patients With Subjective Tinnitus

The purpose of this study is to investigate the safety and efficacy of neramexane mesylate in the treatment of subjective tinnitus in comparison to placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

411

Phase

  • Phase 3

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

  • Austria
      • Graz, Austria, A-8020
        • Krankenhaus der Elisabethinen
      • Kufstein, Austria, A-6330
        • Bezirkskrankenhaus Kufstein
      • Linz, Austria, A-4010
        • A. ö. Krankenhaus der Elisabethinen Linz
      • Salzburg, Austria, A-5020
        • Salzburger Landeskrankenhaus, Universitätsklinik für Hals-Nasen-Ohren-Krankheiten
      • Vienna, Austria, A-1090
        • Clin Pharm International GmbH, Zentrum Wien
  • Germany
      • Aachen, Germany, 52074
        • Dr. med. Nobert Pasch
      • Augsburg, Germany, 86199
        • Dr. Peter Küppers
      • Berlin, Germany, 10117
        • Charité, Universitätsmedizin Berlin-Tinnituszentrum
      • Berlin, Germany, 13125
        • Klin. Forschung Berlin Buch GmbH
      • Braunschweig, Germany, 38100
        • Dr. med. Frank Reintjes
      • Chemnitz, Germany, 09120
        • ClinPharm International
      • Darmstadt, Germany, 64283
        • Dr. Klaus Peter Jayme
      • Dresden, Germany, 01277
        • Dr. Christian Dörr
      • Duisburg, Germany, 47179
        • HNO-Praxis im Gesundheitszentrum Walsum
      • Frankfurt, Germany, 60596
        • ClinPharm International GmbH
      • Görlitz, Germany, 02826
        • ClinPharm International GmbH
      • Heiligenhaus, Germany, 42579
        • Dr. Werner Gieselmann
      • Iserlohn, Germany, 58642
        • Dr. Wolfgang Lotte
      • Leipzig, Germany, 04103
        • ClinPharm International GmbH
      • Lichtenfels, Germany, 96215
        • HNO Praxis
      • Lorsch, Germany, 64653
        • Dr. Dannesberger
      • Magdeburg, Germany, 39104
        • ClinPharm International
      • Meppen, Germany, 48716
        • HNO Gemeinschaftpraxis
      • Munich, Germany
        • LMU München Klinik Großhadern
      • Nürnberg, Germany, 90402
        • Dr. med. Ulrike Walter
      • Nürnberg, Germany, 90443
        • Dr. Susanne Wiedemann
      • Schlüchtern, Germany, 36381
        • Dr. Norbert Staab
      • Wiesbaden, Germany, 65183
        • Dr. Hannelore Neumaier
      • Worms, Germany, 67547
        • Dr. med. Stephanie Göbel
    • Saale
      • Halle, Saale, Germany, 06112
        • Dr. Elisabeth Kühne
  • Portugal
      • Porto, Portugal, 4050-113
        • Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
      • Porto, Portugal, 4050-115
        • Clínica ORL Dr. Eurico de Almeida
  • Spain
      • Alcorcón - Madrid, Spain, 28922
        • Fundación Hospital de Alcorcón, Otorhinolaryngology
      • Barcelona, Spain, 08036
        • Hospital Clínico Barcelona, Dept. Of ORL
      • Jaén, Spain
        • Clinica Clivina, Private Consultancy
      • Linares, Jaén, Spain, 23700
        • Hospital Comarcal San Agustin
      • Lugo, Spain
        • Hospital Xeral-Caldé
      • Madrid, Spain, 28805
        • Hospital Universitario Príncipe de Asturias
      • Madrid, Spain, 28035
        • Hospital Puerta del Hierro, Madrid- Servicio de OR
      • Palma de Mallorca, Spain, 07004
        • Hospital Universtiario Son Dureta
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca- Hospital Virgen de la Vega
      • Sevilla, Spain, 41005
        • Hospital Universitario Virgen del Rocio- Centro de Especialidades Dr. Fleming
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Clínica Universitaria de Navarra, Dept. ORL
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Hospital Sagunto
  • United Kingdom
      • Bath, United Kingdom, BA2 3HT
        • Oldfield Surgery
      • Chesterfield, United Kingdom, S40 4TF
        • Avondale Surgery Research office
      • East Horsley, Leatherhead, Surrey, United Kingdom, KT24 6QT
        • The Horsley Medical Practice
      • Leicester, United Kingdom, LE1 5WW
        • The university Hospitals of Leicester, Leicester Royal Infirmary
      • Leicestershire, United Kingdom, LE10 2SE
        • Burbage Surgery
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • The Freeman Hospital
      • Petereborough, United Kingdom, PE8 6PL
        • Wansford and Kings Cliffe Practice
      • Somerset, United Kingdom, BA11 1EZ
        • Frome Medical Practice
      • Warwick Shire, United Kingdom, CV9 1EU
        • Dr. Trevor Gooding
      • Warwickshire, United Kingdom, CV32 4RA
        • Sherbourne Medical Centre

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 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 18 to 75 years with a clinical diagnosis of first onset,
  • Persistent (i.e. tinnitus should never be absent for > 24 hours in a row), subjective, uni- or bilateral tinnitus present for at least 3 months but not more than 12 months

Exclusion Criteria:

  • Clinical diagnosis of intermittent or pulsatile tinnitus
  • Patients who have tinnitus as a concomitant symptom of an otological/neurological disease (such as otitis media, Menière's disease, otosclerosis, etc)

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
Experimental: 1
Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Placebo Comparator: 2
Drug: Placebo
Double-blind treatment period of 17 weeks placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen-12 "Tinnitus Handicap Inventory-12") total score change from baseline to end of treatment
Time Frame: Screening, Baseline, week 5, 13, 17
Screening, Baseline, week 5, 13, 17

Secondary Outcome Measures

Outcome Measure
Time Frame
TBF-12 factorial scores, individual responder rate, Tinnitus Rating Scale, Sleep Questionnaire, population pharmacokinetics, optional pharmacogenetics
Time Frame: 17 weeks
17 weeks
safety parameters
Time Frame: 17 weeks
17 weeks

Collaborators and Investigators

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

Sponsor

Merz Pharmaceuticals GmbH

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.

Helpful Links

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

September 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

August 21, 2008

First Submitted That Met QC Criteria

August 21, 2008

First Posted (Estimate)

August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

February 4, 2016

Last Update Submitted That Met QC Criteria

February 3, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRZ 92579/TI/3001
  • EudraCT Number 2007-007835-16

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.

Clinical Trials on Subjective Tinnitus

Clinical Trials on Neramexane mesylate

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe