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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

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

  • 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
        • Hopital 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 Śląskiego 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

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
Intervention / Treatment
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

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

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

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

November 1, 2008

Primary Completion (ACTUAL)

June 1, 2010

Study Completion (ACTUAL)

June 1, 2010

Study Registration Dates

First Submitted

October 13, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (ESTIMATE)

October 15, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 1, 2010

Last Update Submitted That Met QC Criteria

June 30, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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