Open-Label, Long-Term Treatment Study, to Assess the Long-Term Safety and Tolerability and Efficacy of Neramexane in Patients With Subjective Tinnitus
- Registration Number
- NCT00827008
- Lead Sponsor
- Merz Pharmaceuticals GmbH
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 821
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1, verum Neramexane mesylate -
- Primary Outcome Measures
Name Time Method 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 54 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (134)
Glacier Ear, Nose, and Throat, Head and Neck Surgery, P.C.
🇺🇸Kalispell, Montana, United States
Hospital Sagunto
🇪🇸Sagunto, Valencia, Spain
Heartland Research Associates, LLC.
🇺🇸Wichita, Kansas, United States
University of Kansas Department of Otolaryngology Head & Neck Surgery
🇺🇸Kansas City, Kansas, United States
Colorado Otolaryngology Associates
🇺🇸Colorado Springs, Colorado, United States
University Hospital Leuven, ENT Department
🇧🇪Leuven, Belgium
Rijnland Ziekenhuis, ENT department
🇳🇱Leiderdorp, GA, Netherlands
Andromed Rotterdam
🇳🇱Rotterdam, HC, Netherlands
Szpital Specjalistyczny im. Stefana Zeromskiego, SP ZOZ w Krakowie, Oddzial Otolaryngologii
🇵🇱Krakow, Poland
Andromed Oost
🇳🇱Velp, ES, Netherlands
AZ Sint Lucas, ENT department
🇧🇪Gent, Belgium
Medico
🇨🇿Chodov, Prague, Czech Republic
ORL oddělení, Všeobecná Fakultní Nemocnice v Praze
🇨🇿Praha, Czech Republic
Unidad Médica de Especialidades del Noroeste (UMEN)
🇲🇽Centro Culiacán Sinaloa, Mexico
Internal Medicine Clin Trials (IMED)
🇲🇽Col Obispado, Monterrey , N.L. C.P. 64060, Mexico
Monterrey International Research Center (MIRC)
🇲🇽Nuevo León CP 64000, Mexico
Andromed Leiden
🇳🇱Leiderdorp, RA, Netherlands
David L. Bortniker, M.D, FACS
🇺🇸Somerville, New Jersey, United States
Krankenhaus der Elisabethinen
🇦🇹Graz, Austria
Bezirkskrankenhaus Kufstein Dr. Christof Pauli (PI: Prim. Dr. Peter Ostertag
🇦🇹Kufstein, Austria
ORL oddělení , Karlovarská krajská nemocnice a. s.
🇨🇿Sokolov, Czech Republic
Clinical Research Instutute S.C.
🇲🇽Edo. de México CP 54055, Mexico
Medical University of South Carolina - Department of Otolaryngology, Department of Otolaryngology - Head & Neck Surgery
🇺🇸Charleston, South Carolina, United States
University Hospital Brussels
🇧🇪Brussels, Belgium
Teaching University Hospital, ORL klinika
🇨🇿Brno, Czech Republic
ORL oddělení, Karlovarská krajská nemocncie a.s.
🇨🇿Karlovy Vary, Czech Republic
Hospital General de Chihuahua. "Dr. Salvador Anchondo"
🇲🇽Chihuahua C.P. 31000, Mexico
Hospital Christus Muguerza del Parque
🇲🇽Chihuahua CP 3100, Mexico
Hospital Central "Dr. Ignacio Morones Prieto" Servicio de Otorrinolaringología
🇲🇽San Luis Potosí, SLP, México, 78240, Mexico
Andromed Zoetermeer
🇳🇱Zoetermeer, EK, Netherlands
Andromed Breda
🇳🇱Breda, VL, Netherlands
Szpital Miejski im. J.Brudzinskiego
🇵🇱Gdynia, Poland
Niepubliczny Zaklad Opieki Zdrowotnej PROMED
🇵🇱Krakow, Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
🇵🇱Wroclaw, Poland
Pro-audio,s.r.o.-private ENT clinic
🇨🇿Mladá Boleslav, Czech Republic
Paradigm Clinical Research
🇺🇸Tucson, Arizona, United States
Clin Pharm International GmbH, Zentrum Wien
🇦🇹Vienna, Austria
Clinique Universitaire Saint-luc
🇧🇪Bruxelles, Belgium
Oblastní nemocnice Kladno a.s., Nemocnice Středočeského kraje
🇨🇿Kladno, Czech Republic
Hospital Civil de Guadalajara
🇲🇽Col. El Retiro CP 44280 Cuadalajara Jalis, Mexico
Grupo Médico Terranova
🇲🇽CP 44630 Guadalajara Jalisco, Mexico
Instituto Biomédico de Investigación A.C.
🇲🇽Fracc. Bosques del Prado Norte Aguascalientes, Mexico
Unidad de Investigación Clínica Cardiometábolica de Occidente S.C. (UNICAMO)
🇲🇽Jalisco, 44150, Mexico
Specjalistyczny Gabinet Otolaryngologiczny
🇵🇱Krakow, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi
🇵🇱Lodz, Poland
Hospital Militar Regional nº 1 Serviço de Otorrinolaringologia
🇵🇹Porto, Portugal
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynała Wyszynskiego Samodzielny Publiczny Zaklad Opieki Zdrowotnej
🇵🇱Lublin, Poland
Wojewodzki Szpital Specjalistyczny w Olsztynie
🇵🇱Olsztyn, Poland
Dr. Sarfati
🇫🇷La seyne sur Mer, France
Prince Alfred House
🇿🇦Wynberg, South Africa
Clínica OTOSUL
🇧🇷Valenca/RJ, Brazil
Hopital Nord
🇫🇷Saint-etienne, France
Wansford and Kings Cliffe Practice
🇬🇧Petereborough, United Kingdom
Hospital Clínico Barcelona, Dept. Of ORL
🇪🇸Barcelona, Spain
Louis Leipoldt Mediclinic
🇿🇦Bellville, South Africa
Fundación Hospital de Alcorcón, Otorhinolaryngology
🇪🇸Alcorcon - Madrid, Spain
Lakeview Hospital
🇿🇦Benoni, South Africa
Instytut Fizjologii i Patologii Sluchu
🇵🇱Warszawa, Poland
1007 Louis Pasteur Building
🇿🇦Pretoria, South Africa
Constantiaberg Medi Clinic,
🇿🇦Western Cape, South Africa
GCT Eastmed Clinical Trial centre
🇿🇦Pretoria, South Africa
Oldfield Surgery
🇬🇧Bath, United Kingdom
Avondale Surgery, Research Office
🇬🇧Chesterfield, United Kingdom
Burbage Surgery
🇬🇧Leicestershire, United Kingdom
Frome Medical Practice
🇬🇧Somerset, United Kingdom
Hospital Puerta del Hierro, Madrid- Servicio de ORL
🇪🇸Madrid, Spain
Clínica Universitaria de Navarra, Dept. ORL
🇪🇸Pamplona, Navarra, Spain
Sherbourne Medical Centre
🇬🇧Warwickshire, United Kingdom
Hospital Universitario de Salamanca- Hospital Virgen de la Vega
🇪🇸Salamanca, Spain
Addenbrooke's Hospital
🇬🇧Cambridge, United Kingdom
The university Hospitals of Leicester, Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
The Freeman Hospital
🇬🇧Newcastle upon Tyne, United Kingdom
Hospital Universitario Príncipe de Asturias
🇪🇸Madrid, Spain
Central California Clinical Research
🇺🇸Fresno, California, United States
New West Physicians
🇺🇸Golden, Colorado, United States
Providence Clinical Research
🇺🇸Burbank, California, United States
UC Davis Health System Department of Otolaryngology
🇺🇸Sacramento, California, United States
Knight Center for Integrated Health,
🇺🇸Peoria, Illinois, United States
Clinical Research of West Florida
🇺🇸Tampa, Florida, United States
Visions Clinical Research
🇺🇸Boynton Beach, Florida, United States
Deerpath Physicians Group
🇺🇸Gurnee, Illinois, United States
Montefiore Medical Center Attn: Anxiety and Depression Center
🇺🇸Bronx, New York, United States
Erie County Medical Center, Department of Rehabilitation Medicine
🇺🇸Buffalo, New York, United States
Immedicenter
🇺🇸Bloomfield, New Jersey, United States
Cary Medical Research
🇺🇸Cary, North Carolina, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Wilmington Medical Research
🇺🇸Wilmington, North Carolina, United States
Piedmont Medical Research
🇺🇸Winston-Salem, North Carolina, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
South Texas Research Alliance LLC
🇺🇸Laredo, Texas, United States
Future Search Trials of Neurology
🇺🇸Austin, Texas, United States
Research Across America
🇺🇸Plano, Texas, United States
Advanced Clinical Research
🇺🇸West Jordon, Utah, United States
Health Research of Hampton Roads, Inc.
🇺🇸Newport News, Virginia, United States
Consultório Dr. Marcelo Rates
🇧🇷Belo Horizonte/Mimaf Gerais, Brazil
Osmar Clayton Person
🇧🇷Santo André/SP, Brazil
Instituto Ganz Sanchez
🇧🇷São Paulo/SP, Brazil
prof. MUDr. Ivo Šlapák
🇨🇿Brno, Czech Republic
Centre Hospitalier de Bretagne Sud Service ORL-B9
🇫🇷Lorient, France
Dr. Ebbo
🇫🇷Issy les moulineaux, France
Dr. Bonfils
🇫🇷Paris, France
Dr. Ohresser
🇫🇷Paris, France
Dr. Fraysse
🇫🇷Toulouse cedex, France
Hopital Paul BROUSSE Polyclinique
🇫🇷Villejuif, France
Service ORL CHU Bretonneau
🇫🇷Tours, France
Dr. med. Norbert Pasch
🇩🇪Aachen, Germany
Dr. Kühne, Elisabeth
🇩🇪Halle, Saale, Germany
Charité, Universitätsmedizin Berlin-Tinnituszentrum
🇩🇪Berlin, Germany
Klin. Forschung Berlin Buch GmbH
🇩🇪Berlin, Germany
Dr. Klaus Peter Jayme
🇩🇪Darmstadt, Germany
Dr. med. Frank Reintjes
🇩🇪Braunschweig, Germany
DM Helena Sigal
🇩🇪Chemnitz, Germany
Dr. Christian Dörr
🇩🇪Dresden, Germany
HNO-Praxis im Gesundheitszentrum
🇩🇪Duisburg, Germany
Dr. Gieselmann, Werner
🇩🇪Heiligenhaus, Germany
Dr. Wolfgang Lotte
🇩🇪Iserlohn, Germany
Dr. Dr. med. Hans-Detlev Stahl
🇩🇪Leipzig, Germany
HNO Praxis
🇩🇪Lichtenfels, Germany
ClinPharm International
🇩🇪Magdeburg, Germany
Dr. Dannesberger
🇩🇪Lorsch, Germany
HNO Gemeinschaftpraxis
🇩🇪Meppen, Germany
Dr. Susanne Wiedemann
🇩🇪Nuernberg, Germany
Martin Canis, MD
🇩🇪Munich, Germany
Dr. Norbert Staab
🇩🇪Schlüchtern, Germany
Dr. med. Ulrike Walter
🇩🇪Nürnberg, Germany
Dr. Hannelore Neumaier
🇩🇪Wiesbaden, Germany
Hospital Universitario Dr. José Eleuterio González. Edificio Elizondo Barragán, Servicio de Otorrinolaringología
🇲🇽Nuevo León CP 64400, Mexico
Adromed Nijmegen
🇳🇱Nijmegen, HL, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Prywatne Centrum Medyczne PROMEDIS
🇵🇱Gdansk, Poland
NZOZ Specjalistyczne Centrum Medyczne Nowomed
🇵🇱Krakow, Poland
Samodzielny Publiczny Szpital Kliniczny im. Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Katowice, Poland
Commonwealth Ear, Nose & Throat
🇺🇸Louisville, Kentucky, United States