Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus (OLLTT)

November 27, 2012 updated by: Merz Pharmaceuticals GmbH

An Open-Label, Long-Term Treatment Study to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane With Subjective Tinnitus

The purpose of this study is to investigate the long-term safety and tolerability and efficacy of neramexane mesylate in the long-term treatment of subjective tinnitus after a completed double-blind randomized placebo controlled study

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

821

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, 8020
        • Krankenhaus der Elisabethinen
      • Kufstein, Austria, 6330
        • Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
      • Vienna, Austria, 1090
        • Clin Pharm International GmbH, Zentrum Wien
  • Belgium
      • Brussels, Belgium, 1090
        • University Hospital Brussels
      • Bruxelles, Belgium, 1200
        • Clinique Universitaire Saint-Luc
      • Gent, Belgium, 9000
        • AZ Sint Lucas, ENT department
      • Leuven, Belgium, 3000
        • University Hospital Leuven, ENT Department
  • Brazil
      • Belo Horizonte/Mimaf Gerais, Brazil, CEP 30150-270
        • Consultório Dr. Marcelo Rates
      • Santo André/SP, Brazil, zip 09060-650
        • Osmar Clayton Person
      • São Paulo/SP, Brazil, ZIP CODE: 05469-000
        • Instituto Ganz Sanchez
      • Valenca/RJ, Brazil, CEP.: 27211-130
        • Clínica OTOSUL
  • Czech Republic
      • Brno, Czech Republic, 602 00
        • prof. MUDr. Ivo Šlapák
      • Brno, Czech Republic, 65691
        • Teaching University Hospital, ORL klinika
      • Karlovy Vary, Czech Republic, 360 66
        • ORL oddělení, Karlovarská krajská nemocncie a.s.
      • Kladno, Czech Republic, 272 59
        • Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje
      • Mladá Boleslav, Czech Republic, 29301
        • Pro-audio,s.r.o.-private ENT clinic
      • Praha, Czech Republic, 128 08
        • ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
      • Sokolov, Czech Republic, 356 01
        • ORL oddělení , Karlovarská krajská nemocnice a. s.
    • Prague
      • Chodov, Prague, Czech Republic, 4
        • Medico
  • France
      • Issy les moulineaux, France, 92130
        • Dr. Ebbo
      • La seyne sur Mer, France, 83500
        • Dr. Sarfati
      • Lorient, France, 2233-56322
        • Centre Hospitalier de Bretagne Sud Service ORL-B9
      • Paris, France, 75015
        • Dr. Bonfils
      • Paris, France, 75015
        • Dr. Ohresser
      • Saint-etienne, France, 42055
        • Hôpital Nord
      • Toulouse cedex, France, 31059
        • Dr. Fraysse
      • Tours, France, 37044
        • Service ORL CHU Bretonneau
      • Villejuif, France, 94800
        • Hopital Paul BROUSSE Polyclinique
  • Germany
      • Aachen, Germany, 52074
        • Dr. med. Norbert Pasch
      • 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
        • DM Helena Sigal
      • Darmstadt, Germany, 64283
        • Dr. Klaus Peter Jayme
      • Dresden, Germany, 01277
        • Dr. Christian Dörr
      • Duisburg, Germany, 47179
        • HNO-Praxis im Gesundheitszentrum
      • Heiligenhaus, Germany, 42579
        • Dr. Gieselmann, Werner
      • Iserlohn, Germany, 58642
        • Dr. Wolfgang Lotte
      • Leipzig, Germany, 04103
        • Dr. Dr. med. Hans-Detlev Stahl
      • Lichtenfels, Germany, 96215
        • HNO Praxis
      • Lorsch, Germany, 64653
        • Dr. Dannesberger
      • Magdeburg, Germany, 39104
        • ClinPharm International
      • Meppen, Germany, 48716
        • HNO Gemeinschaftpraxis
      • Munich, Germany, 81377
        • Martin Canis, MD
      • Nuernberg, Germany, 90443
        • Dr. Susanne Wiedemann
      • Nürnberg, Germany, 90402
        • Dr. med. Ulrike Walter
      • Schlüchtern, Germany, 36381
        • Dr. Norbert Staab
      • Wiesbaden, Germany, 65183
        • Dr. Hannelore Neumaier
    • Saale
      • Halle, Saale, Germany, 06112
        • Dr. Kühne, Elisabeth
  • Mexico
      • CP 44630 Guadalajara Jalisco, Mexico
        • Grupo Médico Terranova
      • Centro Culiacán Sinaloa, Mexico, 80000
        • Unidad Médica de Especialidades del Noroeste (UMEN)
      • Chihuahua C.P. 31000, Mexico
        • Hospital General de Chihuahua. "Dr. Salvador Anchondo"
      • Chihuahua CP 3100, Mexico
        • Hospital Christus Muguerza del Parque
      • Col Obispado, Monterrey , N.L. C.P. 64060, Mexico
        • Internal Medicine Clin Trials (IMED)
      • Col. El Retiro CP 44280 Cuadalajara Jalis, Mexico
        • Hospital Civil de Guadalajara
      • Edo. de México CP 54055, Mexico
        • Clinical Research Instutute S.C.
      • Fracc. Bosques del Prado Norte Aguascalientes, Mexico, CP 20127
        • Instituto Biomedico De Investigacion A.C.
      • Jalisco, 44150, Mexico
        • Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
      • Nuevo León CP 64000, Mexico
        • Monterrey International Research Center (MIRC)
      • Nuevo León CP 64400, Mexico
        • Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología
      • San Luis Potosí, SLP, México, 78240, Mexico
        • Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología
  • Netherlands
    • EK
      • Zoetermeer, EK, Netherlands, 2724
        • Andromed Zoetermeer
    • ES
      • Velp, ES, Netherlands, 6883
        • Andromed Oost
    • GA
      • Leiderdorp, GA, Netherlands, 2353
        • Rijnland Ziekenhuis, ENT department
    • HC
      • Rotterdam, HC, Netherlands, 3021
        • Andromed Rotterdam
    • HL
      • Nijmegen, HL, Netherlands, 6533
        • Adromed Nijmegen
    • RA
      • Leiderdorp, RA, Netherlands, 2352
        • Andromed Leiden
    • VL
      • Breda, VL, Netherlands, 4811
        • Andromed Breda
  • Poland
      • Bialystok, Poland, 15-276
        • 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 Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
      • Krakow, Poland, 30-349
        • NZOZ Specjalistyczne Centrum Medyczne Nowomed
      • Krakow, Poland, 31- 636
        • Niepubliczny Zaklad Opieki Zdrowotnej PROMED
      • Krakow, Poland, 31-534
        • Specjalistyczny Gabinet Otolaryngologiczny
      • Krakow, Poland, 31-913
        • Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
      • Lodz, Poland, 91-153
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego 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
  • Portugal
      • Porto, Portugal, 4050-113
        • Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
  • South Africa
      • Bellville, South Africa, 7530
        • Louis Leipoldt Mediclinic
      • Benoni, South Africa, 1501
        • Lakeview Hospital
      • Pretoria, South Africa, 0002
        • 1007 Louis Pasteur Building
      • Pretoria, South Africa, 0186
        • GCT Eastmed Clinical Trial centre
      • Western Cape, South Africa, 7800
        • Constantiaberg Medi Clinic,
      • Wynberg, South Africa, 7800
        • Prince Alfred House
  • Spain
      • Alcorcon - Madrid, Spain, 28922
        • Fundación Hospital de Alcorcón, Otorhinolaryngology
      • Barcelona, Spain, 08036
        • Hospital Clínico Barcelona, Dept. Of ORL
      • Madrid, Spain, 28035
        • Hospital Puerta del Hierro, Madrid- Servicio de ORL
      • Madrid, Spain, 28805
        • Hospital Universitario Príncipe de Asturias
      • Pamplona, Navarra, Spain, 31008
        • Clínica Universitaria de Navarra, Dept. ORL
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca- Hospital Virgen de la Vega
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Hospital Sagunto
  • United Kingdom
      • Bath, United Kingdom, BA2 3HT
        • Oldfield Surgery
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital
      • Chesterfield, United Kingdom, S40 4TF
        • Avondale Surgery, Research Office
      • 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
      • Warwickshire, United Kingdom, CV32 4RA
        • Sherbourne Medical Centre
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85705
        • Paradigm Clinical Research
    • California
      • Burbank, California, United States, 91505
        • Providence Clinical Research
      • Fresno, California, United States, 93720
        • Central California Clinical Research
      • Sacramento, California, United States, 95817
        • UC Davis Health System Department of Otolaryngology
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Colorado Otolaryngology Associates
      • Golden, Colorado, United States, 80401
        • New West Physicians
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Visions Clinical Research
      • Tampa, Florida, United States, 33603
        • Clinical Research of West Florida
    • Illinois
      • Gurnee, Illinois, United States, 60031
        • Deerpath Physicians Group
      • Peoria, Illinois, United States, 61614
        • Knight Center for Integrated Health,
    • Kansas
      • Kansas City, Kansas, United States, 66160-0001
        • University of Kansas Department of Otolaryngology Head & Neck Surgery
      • Wichita, Kansas, United States, 67205
        • Heartland Research Associates, LLC.
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC.
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Commonwealth Ear, Nose & Throat
    • Montana
      • Kalispell, Montana, United States, 59901
        • Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Immedicenter
      • Somerville, New Jersey, United States, 08876
        • David L. Bortniker, M.D, FACS
    • New York
      • Bronx, New York, United States, 10867
        • Montefiore Medical Center Attn: Anxiety and Depression Center
      • Buffalo, New York, United States, 14221
        • Erie County Medical Center, Department of Rehabilitation Medicine
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cary Medical Research
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Wilmington, North Carolina, United States, 28401
        • Wilmington Medical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research
    • South Carolina
      • Charleston, South Carolina, United States, 29425-5500
        • Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials of Neurology
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc.
      • Laredo, Texas, United States, 78041
        • South Texas Research Alliance LLC
      • Plano, Texas, United States, 75093
        • Research Across America
    • Utah
      • West Jordon, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.

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

Main Inclusion Criteria:

  • Male or female patients who have successfully completed one of the double-blind Phase 3 tinnitus studies of Merz with Neramexane mesylate
  • patients aged equal or older 18 but not older than 75 years with clinical diagnosis of first onset, persistent (i.e. tinnitus should never be absent for more than 24 hours in a row), subjective, uni-or bilateral subacute tinnitus at the timepoint of the lead-in study

Main 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1, verum
Drug: Neramexane mesylate
Up-titration treatment period of 5 weeks up to 75mg Neramexane mesylate oral per day followed by 49 weeks treatment maintenance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Descriptive analyses of TBF-12 (Tinnitus-Beeinträchtigungs-Fragebogen 12 "Tinnitus Handicap Inventory 12")total score and its subscores, of the Tinnitus Rating Scale and its single items as well as of SF-36 and safety/tolerability parameters
Time Frame: 54 weeks
54 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

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 21, 2009

First Submitted That Met QC Criteria

January 21, 2009

First Posted (Estimate)

January 22, 2009

Study Record Updates

Last Update Posted (Estimate)

November 28, 2012

Last Update Submitted That Met QC Criteria

November 27, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MRZ 92579/TI/3004
  • 2008-001432-13 (EudraCT Number)

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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