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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
411

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings