Efficacy, Safety and Tolerability of Neramexane in Comparison to Placebo in Patients With Subjective Tinnitus

June 30, 2010 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 (Anticipated)

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.
400

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

  • Belgium
      • Assebroek-Brugge, Belgium, 8310
        • AZ Sint Lucas, ENT department
      • Brussels, Belgium, 1200
        • Clinique Universitaire Saint-Luc
      • Brussels, Belgium, 1090
        • University Hospital Brussels, ENT department
      • Bruxelles, Belgium, 1200
        • Dr. Henri HABERMAN
      • Gent, Belgium, 9000
        • AZ Sint Lucas, ENT department
      • La Louvière, Belgium, 7100
        • Centre Hospitalier de Jolimont
      • Leuven, Belgium, 3000
        • University Hospital Leuven, ENT Department
      • Liège, Belgium, 4000
        • CHU Liege Service ORL
  • Czech Republic
      • Brno, Czech Republic, 65691
        • Teaching University Hospital, ORL klinika
      • Brno, Czech Republic, 60200
        • Prof. MUDr. Ivo Šlapák, CSc
      • Havlíčkův Brod, Czech Republic, 58022
        • Nemocnice Havlíčkův Brod
      • Jihlava, Czech Republic, 58633
        • ORL - Otorynolaryngologické oddělení
      • Karlovy Vary, Czech Republic, 36066
        • ORL oddělení, Karlovarská krajská nemocncie a.s.
      • Kladno, Czech Republic, 27259
        • Oblastni nemocnice Kladno a.s.
      • Mladá Boleslav, Czech Republic, 29301
        • Pro-audio,s.r.o.-private ENT clinic
      • Praha, Czech Republic, 12808
        • ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
      • Sokolov, Czech Republic, 35601
        • ORL oddělení , Karlovarská krajská nemocnice a. s.
    • Prague
      • Chodov, Prague, Czech Republic
        • Medico
  • France
      • Issy les moulineaux, France, 92130
        • Dr. Ebbo
      • La seyne sur Mer, France, 83500
        • Dr. Sarfati
      • Lorient, France, 56322
        • Centre Hospitalier de Bretagne Sud Service
      • Lyon cedex 03, France, 69437
        • Hôpital Edouard Herriot
      • Paris, France, 75015
        • BONFILS
      • Paris, France, 75015
        • OHRESSER
      • Saint-Etienne, France, 42055
        • Hôpital Nord
      • Toulouse cedex, France, 31059
        • FRAYSSE
      • Tours, France, 37044
        • Service ORL CHU
      • Villejuif, France, 94800
        • Hopital Paul BROUSSE Polyclinique
  • Netherlands
      • Breda, Netherlands, 4811 VL
        • Andromed Breda
      • Leiderdorp, Netherlands, 2352 RA
        • Andromed Leiden
      • Leiderdorp, Netherlands, 2353 GA
        • Rijnland Ziekenhuis, ENT department
      • Nijmegen, Netherlands, 6533 HL
        • Adromed Nijmegen
      • Rotterdam, Netherlands, 3021 HC
        • Andromed Rotterdam
      • Rotterdam, Netherlands, HC 3021
        • Andromed Rotterdam
      • Velp, Netherlands, 6883 ES
        • Andromed Oost
      • Zoetermeer, Netherlands, 2724 EK
        • Andromed Zoetermeer
  • Poland
      • Bialystok, Poland, 15-279
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Gdansk, Poland, 80-288
        • Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
      • Gdynia, Poland, 81-348
        • Szpital Miejski im. J.Brudzinskiego
      • Katowice, Poland, 40-027
        • Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mielęckiego Slaskiego Uniwersytetu Medycznego w Katowicach
      • Krakow, Poland, 30-349
        • NZOZ Specjalistyczne Centrum Medyczne Nowomed
      • Krakow, Poland, 31-913
        • Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
      • Krakow, Poland, 31-534
        • Specjalistyczny Gabinet Otolaryngologiczny Dr Anna Otto- Markiewicz
      • Krakow, Poland, 31-636
        • Niepubliczny Zaklad Opieki Zdrowotnej PROMED
      • Lodz, Poland, 91-153
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
      • Lodz, Poland, 91-348
        • Instytut Medycyny Pracy im. Prof. Dr med. Jerzego Nofera w Lodzi
      • Lublin, Poland, 20-718
        • Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
      • Olsztyn, Poland, 10-561
        • Wojewodzki Szpital Specjalistyczny w Olsztynie
      • Warszawa, Poland, 01-943
        • Instytut Fizjologii i Patologii Sluchu
      • Wroclaw, Poland, 50-369
        • Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu
  • South Africa
      • Bellville, South Africa, 7530
        • Louis Leipoldt Mediclinic
      • Benoni, South Africa, 1501
        • Lakeview Hospital
      • Pretoria, South Africa, 0186
        • GCT Eastmed Clinical Trial centre
      • Pretoria, South Africa, 0002
        • Dr. A. Viljoen
      • Western Cape, South Africa, 7800
        • Constantiaberg Medi Clinic
      • Wynberg, South Africa, 7800
        • Dr. J. Steer

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

18 years to 75 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 sghould never be absent for >24 hours in a row), subjective, uni-or bilateral tinntius 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, Meniére´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
  • Masking: TRIPLE

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: Neramexa mesylate Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day
Drug: Neramexane mesylate
Double-blind treatment period of 17 weeks up to 75 mg Neramexane mesylate per day, 12 weeks follow-up.
PLACEBO_COMPARATOR: 2
Drug: Placebo Double-blind treatment period of 17 weeks placebo
Drug: Placebo
Double-blind treatment period of 17 weeks placebo, 12 weeks follow-up.

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 Handycap 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 respond rate, Tinnitus Rating Scale, Sleep Questionnaire, Qualitiy Of Life, population pharmacokinetics, optional pharmacogenetics
Time Frame: 29 weeks
29 weeks
safety parameters
Time Frame: 29 weeks
29 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

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.
November 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.
June 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.
June 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).
October 13, 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.
October 14, 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.
October 15, 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.
July 1, 2010

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.
June 30, 2010

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.
June 1, 2010

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/3002
  • EudraCT Number 2008-000639-16

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.

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